Diabetes
Conditions
Keywords
mobile health, social support, health disparity, Latino
Brief summary
This is an intervention to study incorporating social support into mHealth interventions for low-income, ED patients with diabetes
Detailed description
Diabetes has disproportionately affected the Latino population. TExT-MED (Trial to Examine Text Message for Emergency Department Patients with Diabetes) is a locally designed, successful mobile health (mHealth) intervention for low income Latinos with diabetes. Social support interventions have likewise been successful at improving patient self-efficacy and disease management but are limited in scale due to two key obstacles: 1) requirements of in-person training of family and friends to be supporters and 2) the need to coordinate schedules and physical location between the patient and their supporter. mHealth can overcome these obstacles by allowing supporters to be trained remotely via a mobile platform and by allowing communication between a patient and supporter to occur at any time or place. The proposed intervention leverages the success of TExT-MED by augmenting the program with a social supporter that each patient can select from his or her own social support system (Family And friend Network Supporters (FANS)), creating TExT-MED+FANS. This is a 12 month, randomized study of this intervention. At the completion of the trial, we will evaluate the user experience with TExT-MED+FANS, and the impact of TExT-MED+FANS on patient motivation, self-efficacy and behaviors through a qualitative analysis of semi-structured individual interviews.
Interventions
BEHAVIORALTExT-MED
messages designed to inspire motivation and behavior change
BEHAVIORALFANS
SMS delivered messages to family members to improve social support
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age \>18 * HbA1c\>8.5 * Social support person identified and contacted
Exclusion criteria
* unable to consent * does not speak/read English or Spanish
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in HBA1c From Baseline | 6 Months | Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in BMI From Baseline | 6 Months | Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker. |
| Change in BMI From 6 Months to 12 Months | 12 Months | Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker. |
| Change in Abdominal Circumference From Baseline | 6 Months | A measure of central adiposity, it correlates with cardiovascular outcomes. |
| Change From Abdominal Circumference From 6 Months to 12 Months | 12 Months | A measure of central adiposity, it correlates with cardiovascular outcomes. |
| Change in Systolic Blood Pressure From Baseline | 6 Months | Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications |
| Change in Systolic Blood Pressure From 6 Months to 12 Months | 12 Months | Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications |
| Change in Diastolic Blood Pressure From Baseline | 6 Months | Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit. |
| Change in Diastolic Blood Pressure From 6 Months to 12 Months | 12 Months | Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit. |
| Change in Summary of Diabetes Self-care Activities From Baseline | 6 Months | Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors. |
| Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | 12 Months | Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors. |
| Change in Wilson 3 Item Scale From Baseline | 6 Months | Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence. |
| Change in Wilson 3 Item Scale From 6 Months to 12 Months | 12 Months | Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence. |
| Change in Healthcare Utilization From Baseline | 6 Months | Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit. |
| Change in Healthcare Utilization From 6 Months to 12 Months | 12 Months | Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit. |
| Change in Diabetes Empowerment Scale Short Form From Baseline | 6 Months | Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy. |
| Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months | 12 months | Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy. |
| Change in HBA1c From 6 Months to 12 Months | 12 months | Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value. |
| Change in Diabetes Distress Scale From 6 Months to 12 Months | 12 Months | Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress |
| Change in Patient Health Questionnaire 9 From Baseline | 6 Months | Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control. |
| Change in Patient Health Questionnaire 9 From 6 Months to 12 Months | 12 Months | Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control. |
| Change in Fatalism From Baseline | 6 Months | Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors. |
| Change in Fatalism From 6 Months to 12 Months | 12 Months | Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors. |
| Change in WHO Quality of Life From Baseline | 6 Months | Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life. |
| Change in WHO Quality of Life From 6 Months to 12 Months | 12 Months | Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life. |
| Change in Diabetes Family Behavior Checklist - Supportive From Baseline | 6 Months | Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total. |
| Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months | 12 Months | Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total. |
| Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline | 6 Months | Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total. |
| Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months | 12 Months | Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total. |
| Change in Diabetes Care Profile Support From Baseline | 6 Months | Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received. |
| Change in Diabetes Care Profile Support From 6 Months to 12 Months | 12 Months | Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received. |
| Change in Norbeck Social Support Questionnaire From Baseline | 6 Months | Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf) |
| Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | 12 Months | Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf) |
| Change in Partner Distress Scale From Baseline | 6 Months | Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, &Johnson, 2016). The self-report scale consists of 21 items in 4 domains: my partner's diabetes management, how best to help, diabetes & me, & hypoglycemia. Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care & lower satisfaction with relationship |
| Change in Diabetes Distress Scale From Baseline | 6 Months | Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| TExT-MED Only Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) in traditional booklet form.
TExT-MED: messages designed to inspire motivation and behavior change | 86 |
| TExT-MED+FANS Patients receive SMS-textmessage curriculum to improve self0-efficacy and self care for diabetes. A patient-identified family member receives a social support curriculum (FANS) by SMS-text-message synchronized by time and content.
TExT-MED: messages designed to inspire motivation and behavior change
FANS: SMS delivered messages to family members to improve social support | 80 |
| Total | 166 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Lost to Follow-up | 29 | 25 |
| Overall Study | Withdrawal by Subject | 10 | 14 |
Baseline characteristics
| Characteristic | Total | TExT-MED Only | TExT-MED+FANS |
|---|---|---|---|
| Abdominal circumference (cm) | 122.90 cm STANDARD_DEVIATION 128.63 | 138.67 cm STANDARD_DEVIATION 174.29 | 104.82 cm STANDARD_DEVIATION 16.61 |
| Age, Continuous | 48.9 years | 50.7 years | 47.7 years |
| BMI | 30.07 kg^m2 STANDARD_DEVIATION 7.6 | 30.78 kg^m2 STANDARD_DEVIATION 7.96 | 29.34 kg^m2 STANDARD_DEVIATION 7.18 |
| Born outside US | 131 Participants | 75 Participants | 56 Participants |
| Diabetes Care Profile Support Perceived Disease Specific Support Needs | 23.61 units on a scale STANDARD_DEVIATION 7.52 | 23.22 units on a scale STANDARD_DEVIATION 7.51 | 24.04 units on a scale STANDARD_DEVIATION 7.55 |
| Diabetes Care Profile Support Perceived Disease Specific Support Received | 18.51 units on a scale STANDARD_DEVIATION 8.92 | 17.91 units on a scale STANDARD_DEVIATION 8.81 | 19.16 units on a scale STANDARD_DEVIATION 9.06 |
| Diabetes Care Profile Support Support Attitudes | 6.49 units on a scale STANDARD_DEVIATION 5.11 | 6.58 units on a scale STANDARD_DEVIATION 5.5 | 6.39 units on a scale STANDARD_DEVIATION 4.68 |
| Diabetes Distress Scale | 2.46 units on a scale STANDARD_DEVIATION 0.1 | 2.32 units on a scale STANDARD_DEVIATION 0.86 | 2.60 units on a scale STANDARD_DEVIATION 1.11 |
| Diabetes Empowerment Scale Short Form | 30.78 units on a scale STANDARD_DEVIATION 5.28 | 30.50 units on a scale STANDARD_DEVIATION 5.56 | 31.09 units on a scale STANDARD_DEVIATION 4.99 |
| Diabetes Family Behavior Checklist Non-Supportive | 18.75 units on a scale STANDARD_DEVIATION 7.22 | 18.27 units on a scale STANDARD_DEVIATION 7.23 | 19.28 units on a scale STANDARD_DEVIATION 7.22 |
| Diabetes Family Behavior Checklist Supportive | 24.09 units on a scale STANDARD_DEVIATION 9.2 | 23.65 units on a scale STANDARD_DEVIATION 9.12 | 24.56 units on a scale STANDARD_DEVIATION 9.32 |
| Diastolic blood pressure | 80.77 mmHg STANDARD_DEVIATION 15.95 | 79.98 mmHg STANDARD_DEVIATION 15.81 | 81.61 mmHg STANDARD_DEVIATION 16.15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 156 Participants | 82 Participants | 74 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 9 Participants | 3 Participants | 6 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Fatalism | 34.94 units on a scale STANDARD_DEVIATION 9.89 | 34.09 units on a scale STANDARD_DEVIATION 9.9 | 35.86 units on a scale STANDARD_DEVIATION 9.85 |
| HbA1c | 10.4 % percentage of hemoglobin glycosylated | 10.3 % percentage of hemoglobin glycosylated | 10.6 % percentage of hemoglobin glycosylated |
| Healthcare Utilization Clinic Visits Made | 3.02 Number of Healthcare Encounters STANDARD_DEVIATION 5.43 | 3.28 Number of Healthcare Encounters STANDARD_DEVIATION 5.61 | 2.74 Number of Healthcare Encounters STANDARD_DEVIATION 5.25 |
| Healthcare Utilization ED/UCC Visits | 2.42 Number of Healthcare Encounters STANDARD_DEVIATION 2.74 | 2.45 Number of Healthcare Encounters STANDARD_DEVIATION 2.12 | 2.38 Number of Healthcare Encounters STANDARD_DEVIATION 3.29 |
| Healthcare Utilization Hospitalization | 0.43 Number of Healthcare Encounters STANDARD_DEVIATION 0.79 | 0.43 Number of Healthcare Encounters STANDARD_DEVIATION 0.8 | 0.44 Number of Healthcare Encounters STANDARD_DEVIATION 0.78 |
| Language Preferred English | 50 Participants | 22 Participants | 28 Participants |
| Language Preferred Spanish | 116 Participants | 64 Participants | 52 Participants |
| Norbeck Social Support Questionnaire Emotional | 13.84 units on a scale STANDARD_DEVIATION 3.23 | 14.00 units on a scale STANDARD_DEVIATION 3.32 | 13.68 units on a scale STANDARD_DEVIATION 3.15 |
| Norbeck Social Support Questionnaire Tangible | 6.99 units on a scale STANDARD_DEVIATION 1.68 | 6.83 units on a scale STANDARD_DEVIATION 1.77 | 7.15 units on a scale STANDARD_DEVIATION 1.57 |
| Partner Distress Scale - Total | 1.42 units on a scale STANDARD_DEVIATION 0.95 | 1.32 units on a scale STANDARD_DEVIATION 0.94 | 1.52 units on a scale STANDARD_DEVIATION 0.95 |
| Patient Health Questionnaire 9 | 9.16 units on a scale STANDARD_DEVIATION 6.63 | 8.90 units on a scale STANDARD_DEVIATION 6.94 | 9.45 units on a scale STANDARD_DEVIATION 6.31 |
| Race (NIH/OMB) American Indian or Alaska Native | 5 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 9 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 2 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 73 Participants | 37 Participants | 36 Participants |
| Race (NIH/OMB) White | 74 Participants | 40 Participants | 34 Participants |
| Region of Enrollment United States | 166 participants | 86 participants | 80 participants |
| Sex: Female, Male Female | 84 Participants | 49 Participants | 35 Participants |
| Sex: Female, Male Male | 82 Participants | 37 Participants | 45 Participants |
| Summary of Diabetes Self-Care Activities Checking feet daily for wounds | 4.06 units on a scale STANDARD_DEVIATION 2.93 | 4.01 units on a scale STANDARD_DEVIATION 3 | 4.11 units on a scale STANDARD_DEVIATION 2.86 |
| Summary of Diabetes Self-Care Activities Following a disease specific diet plan | 3.87 units on a scale STANDARD_DEVIATION 1.9 | 3.98 units on a scale STANDARD_DEVIATION 1.9 | 3.74 units on a scale STANDARD_DEVIATION 1.89 |
| Summary of Diabetes Self-Care Activities Following a generally healthy diet | 3.23 units on a scale STANDARD_DEVIATION 2.47 | 3.38 units on a scale STANDARD_DEVIATION 2.44 | 3.07 units on a scale STANDARD_DEVIATION 2.51 |
| Summary of Diabetes Self-Care Activities Getting sufficient physical activity | 2.47 units on a scale STANDARD_DEVIATION 2.57 | 2.51 units on a scale STANDARD_DEVIATION 2.62 | 2.43 units on a scale STANDARD_DEVIATION 2.53 |
| Summary of Diabetes Self-Care Activities Self-monitoring blood glucose as advised by a h | 2.65 units on a scale STANDARD_DEVIATION 2.92 | 2.55 units on a scale STANDARD_DEVIATION 2.79 | 2.76 units on a scale STANDARD_DEVIATION 3.06 |
| Summary of Diabetes Self-Care Activities Spacing carbohydrates throughout the day | 2.89 units on a scale STANDARD_DEVIATION 2.56 | 2.78 units on a scale STANDARD_DEVIATION 2.65 | 3.00 units on a scale STANDARD_DEVIATION 2.46 |
| Systolic Blood Pressure | 131.30 mmHg STANDARD_DEVIATION 26.88 | 131.55 mmHg STANDARD_DEVIATION 25.02 | 131.03 mmHg STANDARD_DEVIATION 28.9 |
| WHO Quality of life | 60.02 units on a scale STANDARD_DEVIATION 28 | 61.91 units on a scale STANDARD_DEVIATION 26.59 | 58.00 units on a scale STANDARD_DEVIATION 29.48 |
| Wilson 3 Item Scale | 66.53 units on a scale STANDARD_DEVIATION 29.67 | 67.16 units on a scale STANDARD_DEVIATION 31.13 | 65.85 units on a scale STANDARD_DEVIATION 28.23 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 86 | 1 / 80 |
| other Total, other adverse events | 0 / 86 | 0 / 80 |
| serious Total, serious adverse events | 21 / 86 | 19 / 80 |
Outcome results
Primary
Change in HBA1c From Baseline
Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is baseline value minus follow up value.
Time frame: 6 Months
Population: 2 of the HbA1c were collected from electronic healthcare records in the active control group. 1 intervention group patient refused blood draw at follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in HBA1c From Baseline | 1.42 %mmHg/dL |
| TExT-MED+FANS | Change in HBA1c From Baseline | 1.34 %mmHg/dL |
Secondary
Change From Abdominal Circumference From 6 Months to 12 Months
A measure of central adiposity, it correlates with cardiovascular outcomes.
Time frame: 12 Months
Population: abdominal circumference not measured in 9 participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change From Abdominal Circumference From 6 Months to 12 Months | 0.99 cm | Standard Deviation 5.1 |
| TExT-MED+FANS | Change From Abdominal Circumference From 6 Months to 12 Months | 0.85 cm | Standard Deviation 18.51 |
| Total | Change From Abdominal Circumference From 6 Months to 12 Months | 0.93 cm | Standard Deviation 12.7 |
Secondary
Change in Abdominal Circumference From Baseline
A measure of central adiposity, it correlates with cardiovascular outcomes.
Time frame: 6 Months
Population: abdominal circumference unable to be collected from 20 patients
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Abdominal Circumference From Baseline | 1.58 cm | Standard Deviation 14.7 |
| TExT-MED+FANS | Change in Abdominal Circumference From Baseline | 2.73 cm | Standard Deviation 22.54 |
| Total | Change in Abdominal Circumference From Baseline | 2.11 cm | Standard Deviation 18.62 |
Secondary
Change in BMI From 6 Months to 12 Months
Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.
Time frame: 12 Months
Population: 5 participants unable stand to provide weight
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in BMI From 6 Months to 12 Months | -3.38 kg^m2 | Standard Deviation 22.51 |
| TExT-MED+FANS | Change in BMI From 6 Months to 12 Months | 4.02 kg^m2 | Standard Deviation 24.88 |
| Total | Change in BMI From 6 Months to 12 Months | -0.04 kg^m2 | Standard Deviation 23.75 |
Secondary
Change in BMI From Baseline
Calculated from Weight and Height. As a measure of adiposity, it correlates positively with cardiovascular disease outcomes. While imperfect, it is an easily measured and validated marker.
Time frame: 6 Months
Population: 4 participants were not able to stand on the scale to measure weight
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in BMI From Baseline | -7.91 kg^m2 | Standard Deviation 33.8 |
| TExT-MED+FANS | Change in BMI From Baseline | -3.84 kg^m2 | Standard Deviation 22.94 |
| Total | Change in BMI From Baseline | -5.96 kg^m2 | Standard Deviation 29.03 |
Secondary
Change in Diabetes Care Profile Support From 6 Months to 12 Months
Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.
Time frame: 12 Months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Needs | -0.38 units on a scale | Standard Deviation 8.17 |
| TExT-MED Only | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Received | -1.38 units on a scale | Standard Deviation 7.54 |
| TExT-MED Only | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Support Attitudes | -0.77 units on a scale | Standard Deviation 4.56 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Received | 2.70 units on a scale | Standard Deviation 8.17 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Needs | 0.40 units on a scale | Standard Deviation 10.31 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Support Attitudes | 0.08 units on a scale | Standard Deviation 4.01 |
| Total | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Support Attitudes | -0.38 units on a scale | Standard Deviation 4.31 |
| Total | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Needs | -0.02 units on a scale | Standard Deviation 9.17 |
| Total | Change in Diabetes Care Profile Support From 6 Months to 12 Months | Perceived Disease Specific Support Received | 0.49 units on a scale | Standard Deviation 8.06 |
Secondary
Change in Diabetes Care Profile Support From Baseline
Diabetes-specific social support is measured by the Diabetes Care Profile Support Questions,(Fitzgerald et al., 1996) with sub-scores for perceived disease specific support needs and perceived disease specific support received. Diabetes Care Profile support questions: Support wanted, and support received. Each range from 5 to 30, high scores indicating high desire for support and higher support received.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Needs | 4.44 units on a scale | Standard Error 10.79 |
| TExT-MED Only | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Received | -0.08 units on a scale | Standard Error 9.68 |
| TExT-MED Only | Change in Diabetes Care Profile Support From Baseline | Support Attitudes | 0.96 units on a scale | Standard Error 6.51 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Received | -3.65 units on a scale | Standard Error 9.11 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From Baseline | Support Attitudes | -0.87 units on a scale | Standard Error 5.73 |
| TExT-MED+FANS | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Needs | 5.80 units on a scale | Standard Error 9.06 |
| Total | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Needs | 5.08 units on a scale | Standard Error 9.99 |
| Total | Change in Diabetes Care Profile Support From Baseline | Support Attitudes | 0.10 units on a scale | Standard Error 6.2 |
| Total | Change in Diabetes Care Profile Support From Baseline | Perceived Disease Specific Support Received | -1.76 units on a scale | Standard Error 9.54 |
Secondary
Change in Diabetes Distress Scale From 6 Months to 12 Months
Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Distress Scale From 6 Months to 12 Months | 0.06 units on a scale | Standard Deviation 0.92 |
| TExT-MED+FANS | Change in Diabetes Distress Scale From 6 Months to 12 Months | -0.01 units on a scale | Standard Deviation 0.71 |
| Total | Change in Diabetes Distress Scale From 6 Months to 12 Months | 0.03 units on a scale | Standard Deviation 0.83 |
Secondary
Change in Diabetes Distress Scale From Baseline
Diabetes related distress (Diabetes Distress Scale) (Polonsky et al., 2005), is a 17 item scale measuring distress related to emotional burden, physician-related distress, regimen-related distress, and diabetes-related interpersonal issues. It has a Cronbach's alpha of 0.88-0.93 in various studies. Higher scores are negatively correlated with several healthy behaviors. Each question is a Likert scale ranking of how serious a particular issue is from 1-6, 6 indicating a more significant problem. The scores are then averaged across all item, with final scores ranging from 1-6, with 6 indicating higher levels of distress
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Distress Scale From Baseline | 0.65 units on a scale | Standard Deviation 0.97 |
| TExT-MED+FANS | Change in Diabetes Distress Scale From Baseline | 0.60 units on a scale | Standard Deviation 1.15 |
| Total | Change in Diabetes Distress Scale From Baseline | 0.63 units on a scale | Standard Deviation 1.06 |
Secondary
Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months
Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.
Time frame: 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months | 0.13 units on a scale | Standard Deviation 0.49 |
| TExT-MED+FANS | Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months | -0.03 units on a scale | Standard Deviation 0.54 |
| Total | Change in Diabetes Empowerment Scale Short Form From 6 Months to 12 Months | 0.05 units on a scale | Standard Deviation 0.52 |
Secondary
Change in Diabetes Empowerment Scale Short Form From Baseline
Change in Self-efficacy. Diabetes Empowerment Scale Short Form (Anderson, Fitzgerald, Gruppen, Funnell, & Oh, 2003), is a measure of a patient's overall diabetes related self-efficacy, shortened by the original from 37 to an 8 item scale. It has reliability of alpha=0.84; and has been shown to be sensitive to change in multiple populations and is correlated with improved glycemic control measured by A1C (Anderson et al., 2003). It ranges from 8-40 points; higher score indicates higher self-efficacy.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Empowerment Scale Short Form From Baseline | -0.17 units on a scale | Standard Deviation 0.63 |
| TExT-MED+FANS | Change in Diabetes Empowerment Scale Short Form From Baseline | -0.05 units on a scale | Standard Deviation 0.69 |
| Total | Change in Diabetes Empowerment Scale Short Form From Baseline | -0.11 units on a scale | Standard Deviation 0.66 |
Secondary
Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months
Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time frame: 12 Months
Population: patients who achieved follow up at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months | -.85 units on a scale | Standard Deviation 6.1 |
| TExT-MED+FANS | Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months | -1.13 units on a scale | Standard Deviation 6.93 |
| Total | Change in Diabetes Family Behavior Checklist Nonsupportive From 6 Months to 12 Months | -.98 units on a scale | Standard Deviation 6.46 |
Secondary
Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline
Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline | .58 units on a scale | Standard Deviation 6.25 |
| TExT-MED+FANS | Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline | .56 units on a scale | Standard Deviation 6.86 |
| Total | Change in Diabetes Family Behavior Checklist - Nonsupportive From Baseline | .57 units on a scale | Standard Deviation 6.51 |
Secondary
Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months
Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time frame: 12 Months
Population: patients who achieved follow up at 12 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months | -.70 units on a scale | Standard Deviation 7.87 |
| TExT-MED+FANS | Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months | -.98 units on a scale | Standard Deviation 9.32 |
| Total | Change in Diabetes Family Behavior Checklist Supportive From 6 Months to 12 Months | -.83 units on a scale | Standard Deviation 8.52 |
Secondary
Change in Diabetes Family Behavior Checklist - Supportive From Baseline
Diabetes-related supportive and obstructive family behaviors are measured by patient report on the Diabetes Family Behavior checklist (Lewin et al., 2005). Family behaviors: supportive and non-supportive sub-scores of the Diabetes Family Behavior Checklist: supportive ranges from 4-45 (4 being lowest in family supportive behavior), non-supportive ranges from 7-35 (4 indicating least report of non-supportive behavior). Non-supportive scores are subtracted form supportive scores for a total.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diabetes Family Behavior Checklist - Supportive From Baseline | .58 units on a scale | Standard Deviation 7.99 |
| TExT-MED+FANS | Change in Diabetes Family Behavior Checklist - Supportive From Baseline | .12 units on a scale | Standard Deviation 9.08 |
| Total | Change in Diabetes Family Behavior Checklist - Supportive From Baseline | .36 units on a scale | Standard Deviation 8.48 |
Secondary
Change in Diastolic Blood Pressure From 6 Months to 12 Months
Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
Time frame: 12 Months
Population: 11 patients with DBP unable to be obtained
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diastolic Blood Pressure From 6 Months to 12 Months | -0.82 mmHg | Standard Deviation 17.39 |
| TExT-MED+FANS | Change in Diastolic Blood Pressure From 6 Months to 12 Months | 5.20 mmHg | Standard Deviation 20.15 |
| Total | Change in Diastolic Blood Pressure From 6 Months to 12 Months | 1.95 mmHg | Standard Deviation 18.82 |
Secondary
Change in Diastolic Blood Pressure From Baseline
Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the diastolic blood pressure for that visit.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Diastolic Blood Pressure From Baseline | -0.27 mmHg | Standard Deviation 17.11 |
| TExT-MED+FANS | Change in Diastolic Blood Pressure From Baseline | -2.56 mmHg | Standard Deviation 20.09 |
| Total | Change in Diastolic Blood Pressure From Baseline | -1.36 mmHg | Standard Deviation 18.53 |
Secondary
Change in Fatalism From 6 Months to 12 Months
Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.
Time frame: 12 Months
Population: 5 participants decline to answer questions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Fatalism From 6 Months to 12 Months | -1.30 units on a scale | Standard Deviation 8.97 |
| TExT-MED+FANS | Change in Fatalism From 6 Months to 12 Months | -1.20 units on a scale | Standard Deviation 8.51 |
| Total | Change in Fatalism From 6 Months to 12 Months | -1.26 units on a scale | Standard Deviation 8.7 |
Secondary
Change in Fatalism From Baseline
Fatalism is measured by the Diabetes Fatalism Scale (Egede & Ellis, 2010), which measures three subscale emotional distress, religiosity and coping and perceived self-efficacy, which are summed together. The total score ranges from 12-72, higher score indicates higher fatalism, and has a Cronbach's alpha of 0.80. The score is associated with glycemic control, depression, self-care behaviors and social factors.
Time frame: 6 Months
Population: 2 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Fatalism From Baseline | -1.44 units on a scale | Standard Deviation 9.47 |
| TExT-MED+FANS | Change in Fatalism From Baseline | 0.58 units on a scale | Standard Deviation 10.61 |
| Total | Change in Fatalism From Baseline | -0.47 units on a scale | Standard Deviation 10.03 |
Secondary
Change in HBA1c From 6 Months to 12 Months
Glycemic control is measured by hemoglobin A1C collected at point-of-care from an Afinion AS100 capillary point of care machine. The Afinion machine has excellent point of care correlation with laboratory values. As a surrogate for average glycemic control over the previous 3 months and with correlation with clinical outcomes, hemoglobin A1c is a marker of overall clinical disease management. Change is 6 month value minus 12 month value.
Time frame: 12 months
Population: 2 intervention group patient refused blood draw at follow up.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in HBA1c From 6 Months to 12 Months | -.36 %mmHg/dL |
| TExT-MED+FANS | Change in HBA1c From 6 Months to 12 Months | .28 %mmHg/dL |
Secondary
Change in Healthcare Utilization From 6 Months to 12 Months
Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
Time frame: 12 Months
Population: all patients initially enrolled in trial followed in EMR
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Healthcare Utilization From 6 Months to 12 Months | ED/UCC Visit | 0.07 Number of Healthcare Encounters | Standard Deviation 1.35 |
| TExT-MED Only | Change in Healthcare Utilization From 6 Months to 12 Months | Clinic Visits Made | 1.10 Number of Healthcare Encounters | Standard Deviation 4.3 |
| TExT-MED Only | Change in Healthcare Utilization From 6 Months to 12 Months | Hospitalization | -.02 Number of Healthcare Encounters | Standard Deviation 0.65 |
| TExT-MED+FANS | Change in Healthcare Utilization From 6 Months to 12 Months | ED/UCC Visit | .05 Number of Healthcare Encounters | Standard Deviation 1.57 |
| TExT-MED+FANS | Change in Healthcare Utilization From 6 Months to 12 Months | Hospitalization | 0 Number of Healthcare Encounters | Standard Deviation 0.83 |
| TExT-MED+FANS | Change in Healthcare Utilization From 6 Months to 12 Months | Clinic Visits Made | .88 Number of Healthcare Encounters | Standard Deviation 6.3 |
| Total | Change in Healthcare Utilization From 6 Months to 12 Months | ED/UCC Visit | .06 Number of Healthcare Encounters | Standard Deviation 1.46 |
| Total | Change in Healthcare Utilization From 6 Months to 12 Months | Clinic Visits Made | .99 Number of Healthcare Encounters | Standard Deviation 5.34 |
| Total | Change in Healthcare Utilization From 6 Months to 12 Months | Hospitalization | -.01 Number of Healthcare Encounters | Standard Deviation 0.74 |
Secondary
Change in Healthcare Utilization From Baseline
Healthcare utilization by EMR review of clinic appointments, ED visits and hospitalizations within enrollment through 6 months at each follow up visit.
Time frame: 6 Months
Population: 166 patients who initially enrolled followed in EMR
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Healthcare Utilization From Baseline | Hospitalization | 0.24 Number of Healthcare Encounters | Standard Deviation 0.72 |
| TExT-MED Only | Change in Healthcare Utilization From Baseline | ED/UCC Visit | 1.47 Number of Healthcare Encounters | Standard Deviation 1.87 |
| TExT-MED Only | Change in Healthcare Utilization From Baseline | Clinic Visits Made | -.97 Number of Healthcare Encounters | Standard Deviation 3.87 |
| TExT-MED+FANS | Change in Healthcare Utilization From Baseline | Hospitalization | .13 Number of Healthcare Encounters | Standard Deviation 0.96 |
| TExT-MED+FANS | Change in Healthcare Utilization From Baseline | ED/UCC Visit | .88 Number of Healthcare Encounters | Standard Deviation 2.22 |
| TExT-MED+FANS | Change in Healthcare Utilization From Baseline | Clinic Visits Made | -2 Number of Healthcare Encounters | Standard Deviation 6.45 |
| Total | Change in Healthcare Utilization From Baseline | ED/UCC Visit | 1.18 Number of Healthcare Encounters | Standard Deviation 2.06 |
| Total | Change in Healthcare Utilization From Baseline | Clinic Visits Made | -1.46 Number of Healthcare Encounters | Standard Deviation 5.28 |
| Total | Change in Healthcare Utilization From Baseline | Hospitalization | .19 Number of Healthcare Encounters | Standard Deviation 0.84 |
Secondary
Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months
Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
Time frame: 12 Months
Population: 2 participants decline to answer question
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Tangible | -0.36 units on a scale | Standard Deviation 2.17 |
| TExT-MED Only | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Emotional | -0.48 units on a scale | Standard Deviation 4.03 |
| TExT-MED+FANS | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Tangible | 0.48 units on a scale | Standard Deviation 2.08 |
| TExT-MED+FANS | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Emotional | 0.69 units on a scale | Standard Deviation 4.01 |
| Total | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Tangible | 0.02 units on a scale | Standard Deviation 2.16 |
| Total | Change in Norbeck Social Support Questionnaire From 6 Months to 12 Months | Emotional | 0.06 units on a scale | Standard Deviation 4.04 |
Secondary
Change in Norbeck Social Support Questionnaire From Baseline
Measure Description: General social support is captured by the Norbeck Social Support Questionnaire Emotional and&Tangible subscales.(Norbeck, Lindsey, & Carrieri, 1981) General social support: Norbeck Social Support Questionnaire, emotional sub score (ranges 0-16, with higher scores indicating higher perceived emotional support) & tangible sub score (0-8, higher score indicating higher perceived tangible support). While the subscores are highly correlated, the authors do not recommend Cronbach's alpha as a test of internal validity.(http://eileengigliotti.com/uploads/1/1/0/2/110241155/nssq-psychometric.pdf)
Time frame: 6 Months
Population: 10 participants decline to answer questions. 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Norbeck Social Support Questionnaire From Baseline | Emotional | 0.64 units on a scale | Standard Deviation 4.02 |
| TExT-MED Only | Change in Norbeck Social Support Questionnaire From Baseline | Tangible | 0.06 units on a scale | Standard Deviation 1.99 |
| TExT-MED+FANS | Change in Norbeck Social Support Questionnaire From Baseline | Emotional | -0.22 units on a scale | Standard Deviation 4.41 |
| TExT-MED+FANS | Change in Norbeck Social Support Questionnaire From Baseline | Tangible | -0.29 units on a scale | Standard Deviation 2.02 |
| Total | Change in Norbeck Social Support Questionnaire From Baseline | Emotional | 0.24 units on a scale | Standard Deviation 4.2 |
| Total | Change in Norbeck Social Support Questionnaire From Baseline | Tangible | -0.10 units on a scale | Standard Deviation 2 |
Secondary
Change in Partner Distress Scale From Baseline
Supporter diabetes-related distress is measured by the Partner Distress Scale (Polonsky, Fisher, Hessler, &Johnson, 2016). The self-report scale consists of 21 items in 4 domains: my partner's diabetes management, how best to help, diabetes & me, & hypoglycemia. Domains are summed together. Each item is score from 0 to 4, lower scores indicate less distress. The total score is an average of the 21 items. The Cronbach's alpha was 0.76 for total scores. Greater partner distress is correlated with higher A1C among patients, worse self-care & lower satisfaction with relationship
Time frame: 6 Months
Population: Supporters who were reached for follow up at 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Partner Distress Scale From Baseline | .45 units on a scale | Standard Deviation 0.83 |
| TExT-MED+FANS | Change in Partner Distress Scale From Baseline | .13 units on a scale | Standard Deviation 0.89 |
| Total | Change in Partner Distress Scale From Baseline | .37 units on a scale | Standard Deviation 0.89 |
Secondary
Change in Patient Health Questionnaire 9 From 6 Months to 12 Months
Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
Time frame: 12 Months
Population: 2 participants decline to answer questions
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Patient Health Questionnaire 9 From 6 Months to 12 Months | -0.18 units on a scale | Standard Deviation 6.86 |
| TExT-MED+FANS | Change in Patient Health Questionnaire 9 From 6 Months to 12 Months | -0.13 units on a scale | Standard Deviation 5.17 |
| Total | Change in Patient Health Questionnaire 9 From 6 Months to 12 Months | -0.15 units on a scale | Standard Deviation 6.09 |
Secondary
Change in Patient Health Questionnaire 9 From Baseline
Depression as measured by the PHQ-9 (Kroenke, Spitzer, Williams, & Lowe, 2010), is a widely used scale of depression used in clinical practice and research. The Cronbach's alpha ranges from 0.86-0.89, and it has been validated in multiple languages. Depression is worse with higher scores. Score ranges from 0 to 27. Higher levels of depression are associated with fewer healthy behaviors and worse glycemic control.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 1 participant decline to answer question
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Patient Health Questionnaire 9 From Baseline | 3.86 units on a scale | Standard Error 6.19 |
| TExT-MED+FANS | Change in Patient Health Questionnaire 9 From Baseline | 2.33 units on a scale | Standard Error 6.2 |
| Total | Change in Patient Health Questionnaire 9 From Baseline | 3.13 units on a scale | Standard Error 6.21 |
Secondary
Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months
Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
Time frame: 12 Months
Population: one participant did not answer carb spacing as they did not know what that meant.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a generally healthy diet | 0.23 units on a scale | Standard Deviation 2.5 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a disease specific diet plan | 0.29 units on a scale | Standard Deviation 1.85 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Self-monitoring blood glucose as advised by a h | -0.66 units on a scale | Standard Deviation 3.19 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Checking feet daily for wounds | -0.81 units on a scale | Standard Deviation 2.64 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Carb Spacing carbohydrates throughout the day | 0.11 units on a scale | Standard Deviation 4.51 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Getting sufficient physical activity | 0.11 units on a scale | Standard Deviation 2.97 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Getting sufficient physical activity | 0.81 units on a scale | Standard Deviation 2.88 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a generally healthy diet | 0.96 units on a scale | Standard Deviation 2.74 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Checking feet daily for wounds | 0.01 units on a scale | Standard Deviation 1.93 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Carb Spacing carbohydrates throughout the day | 0.31 units on a scale | Standard Deviation 3.89 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a disease specific diet plan | 0.45 units on a scale | Standard Deviation 1.85 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Self-monitoring blood glucose as advised by a h | -0.18 units on a scale | Standard Deviation 2.4 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a disease specific diet plan | 0.36 units on a scale | Standard Deviation 1.84 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Self-monitoring blood glucose as advised by a h | -0.44 units on a scale | Standard Deviation 2.84 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Getting sufficient physical activity | 0.43 units on a scale | Standard Deviation 2.94 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Checking feet daily for wounds | -0.43 units on a scale | Standard Deviation 2.36 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Following a generally healthy diet | 0.57 units on a scale | Standard Deviation 2.62 |
| Total | Change in Summary of Diabetes Self-care Activities From 6 Months to 12 Months | Carb Spacing carbohydrates throughout the day | 0.20 units on a scale | Standard Deviation 4.22 |
Secondary
Change in Summary of Diabetes Self-care Activities From Baseline
Summary of Diabetes Self-care Activities (Toobert, Hampson, Glasgow, & RE, 2000). The Summary consists of 6 subscales representing different domains of diabetes related healthy behaviors and self-care. It has been validated in over 10 studies, with the results published in two manuscripts: one with three studies (Toobert & Glasgow, 1994), and one with seven studies(Toobert et al., 2000). Each measure ranges from Each range from 0-7, indicating number of days per week patient reports engaging in these behaviors.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Following a generally healthy diet | -1.55 units on a scale | Standard Deviation 2.91 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Following a disease specific diet plan | -0.42 units on a scale | Standard Deviation 2.12 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Self-monitoring blood glucose as advised by a h | -0.91 units on a scale | Standard Deviation 3 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Checking feet daily for wounds | -1.25 units on a scale | Standard Deviation 2.96 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Spacing carbohydrates throughout the day | -0.71 units on a scale | Standard Deviation 4.34 |
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities From Baseline | Getting sufficient physical activity | -0.39 units on a scale | Standard Deviation 2.99 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Getting sufficient physical activity | -0.90 units on a scale | Standard Deviation 3.14 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Following a generally healthy diet | -1.17 units on a scale | Standard Deviation 2.69 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Checking feet daily for wounds | -1.36 units on a scale | Standard Deviation 2.69 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Spacing carbohydrates throughout the day | -0.20 units on a scale | Standard Deviation 3.31 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Following a disease specific diet plan | -0.78 units on a scale | Standard Deviation 1.93 |
| TExT-MED+FANS | Change in Summary of Diabetes Self-care Activities From Baseline | Self-monitoring blood glucose as advised by a h | -0.10 units on a scale | Standard Deviation 2.84 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Following a disease specific diet plan | -0.59 units on a scale | Standard Deviation 2.03 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Self-monitoring blood glucose as advised by a h | -0.53 units on a scale | Standard Deviation 2.94 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Getting sufficient physical activity | -0.63 units on a scale | Standard Deviation 3.06 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Checking feet daily for wounds | -1.30 units on a scale | Standard Deviation 2.83 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Following a generally healthy diet | -1.37 units on a scale | Standard Deviation 2.8 |
| Total | Change in Summary of Diabetes Self-care Activities From Baseline | Spacing carbohydrates throughout the day | -0.47 units on a scale | Standard Deviation 3.89 |
Secondary
Change in Systolic Blood Pressure From 6 Months to 12 Months
Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications
Time frame: 12 Months
Population: 11 patients with SBP unable to be obtained
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Systolic Blood Pressure From 6 Months to 12 Months | -4.95 mmHg | Standard Deviation 31.81 |
| TExT-MED+FANS | Change in Systolic Blood Pressure From 6 Months to 12 Months | 2.09 mmHg | Standard Deviation 37.46 |
| Total | Change in Systolic Blood Pressure From 6 Months to 12 Months | -1.71 mmHg | Standard Deviation 34.47 |
Secondary
Change in Systolic Blood Pressure From Baseline
Blood pressure is measured by study RAs after the patient is seated for 5 minutes, with the average of three readings used as the systolic blood pressure for that visit. Systolic blood pressure is associated with cardiovascular complications
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available. 2 participants refused BP measurement
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Systolic Blood Pressure From Baseline | -9.11 mmHg | Standard Deviation 30.45 |
| TExT-MED+FANS | Change in Systolic Blood Pressure From Baseline | -13.07 mmHg | Standard Deviation 36.34 |
| Total | Change in Systolic Blood Pressure From Baseline | -11.00 mmHg | Standard Deviation 33.28 |
Secondary
Change in WHO Quality of Life From 6 Months to 12 Months
Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
Time frame: 12 Months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in WHO Quality of Life From 6 Months to 12 Months | 0.09 units on a scale | Standard Deviation 34.02 |
| TExT-MED+FANS | Change in WHO Quality of Life From 6 Months to 12 Months | 6.30 units on a scale | Standard Deviation 29.9 |
| Total | Change in WHO Quality of Life From 6 Months to 12 Months | 2.94 units on a scale | Standard Deviation 32.16 |
Secondary
Change in WHO Quality of Life From Baseline
Quality of life (World Health Organization WHO-5 Well Being Index) (Topp, Ostergaard, Sondergaard, & Bech, 2015) is a widely used measure of quality life, validated in many languages and consists of only 5 items. Each self-reported item is scored between 0 and 5, summed together and then multiplied by 4. The total range is from 0 to 100, with 0 being the lowest quality of life.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in WHO Quality of Life From Baseline | -9.69 units on a scale | Standard Deviation 31.47 |
| TExT-MED+FANS | Change in WHO Quality of Life From Baseline | -4.96 units on a scale | Standard Deviation 29.86 |
| Total | Change in WHO Quality of Life From Baseline | -7.47 units on a scale | Standard Deviation 30.66 |
Secondary
Change in Wilson 3 Item Scale From 6 Months to 12 Months
Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.
Time frame: 12 Months
Population: 1 Participant decline to answer question
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Wilson 3 Item Scale From 6 Months to 12 Months | 1.74 units on a scale | Standard Deviation 18.92 |
| TExT-MED+FANS | Change in Wilson 3 Item Scale From 6 Months to 12 Months | 3.22 units on a scale | Standard Deviation 22.89 |
| Total | Change in Wilson 3 Item Scale From 6 Months to 12 Months | 2.43 units on a scale | Standard Deviation 20.75 |
Secondary
Change in Wilson 3 Item Scale From Baseline
Medication adherence(Wilson et al.,2014). The 3item medication adherence scale is a self-report measure that assessing no. of days medication missed in prior month, days taken medication as advised & self-rated medication adherence. Developed in HIV research, it has been validated for non-HIV medications (Wilson, et al,2016). Each component contributes 33% of the scale. Total score ranges from 0-100. It is the combination of 3 sub-scores, (days missed dose(negative scored), self-rating, days taking medications as indicated). Higher scores indicate better medication adherence.
Time frame: 6 Months
Population: 2 participants in active control arm did not attend follow up visit. Hba1c taken from medical records, no other data available.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| TExT-MED Only | Change in Wilson 3 Item Scale From Baseline | -15.73 units on a scale | Standard Deviation 30.87 |
| TExT-MED+FANS | Change in Wilson 3 Item Scale From Baseline | -12.39 units on a scale | Standard Deviation 31.11 |
| Total | Change in Wilson 3 Item Scale From Baseline | -14.16 units on a scale | Standard Deviation 30.87 |