Diabetes Mellitus
Conditions
Keywords
Hispanic Americans, Cellular Phone, Behavior
Brief summary
In this study, an existing mobile health intervention to improve diabetes self-management will be combined with a social support module and tested for feasibility. The investigators hypothesize that this combination will be feasible and acceptable to both patients and their loved ones.
Detailed description
This will be the first ever evaluation of a highly scalable and low-cost social support intervention for patients with diabetes delivered entirely via mobile phones. TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) will unite the benefits of mHealth (scalability, ease of access) and social support interventions (personalized motivation, emotional support). The Diabetes FANS text message based curriculum will make it easier for friends and family to become supporters. Additionally, augmenting TExT-MED with the FANS social support module will be more effective than TExT-MED alone. The personalized support of TExT-MED FANS will also be more effective than providing TExT-MED in combination with a community health worker supporter who lacks a pre-existing relationship with the patient. Through this innovative combination, I can create a more cost-effective and diffusible mHealth solution that maintains the personal connection of social support interventions. To date there has only been one study evaluating social support interventions for patients with diabetes using mHealth, but in this study participants were paired with other subjects with diabetes (not friends or family) and it required intensive face-to-face support group time. TExT-MED FANS will provide key insights into the utility of combining social support interventions delivered solely via mHealth in low-income Latino patients. These insights will help future interventions achieve maximal impact on diabetes and other chronic disease management.
Interventions
BEHAVIORALTExT MED
educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
BEHAVIORALFANS
supporter curriculum of messages, consisting of educational/motivational messages, and support challenges
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* type II diabetes * HbA1c \>or=8 at enrollment * speak English or Spanish * has support person willing to participate
Exclusion criteria
* unable to consent * pediatric patient
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Feasibility | 3 months after enrollment | Number of patients lost to follow-up |
| Acceptability | 3 months after enrollment | Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program? |
| Acceptability 2: Would Patients Recommend the Program to Family or Friends? | 3 months follow up | Response to: Would you recommend TExT-MED FANS to family or friends? |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic Control | 3 months after enrollment | glycosylated hemoglobin A1c |
| Body Mass Index | 3 months after enrollment | height and weight measurements |
| Change in Summary of Diabetes Self-care Activities - General Diet Sub Score | 3 months follow up | change in number of days patient followed a general diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score | 3 months follow up | change in number of days patient followed a diabetes specific diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Diabetes Knowledge Test Scale | 3 months after enrollment | Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum |
| Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score | 3 months follow up | change in number of days patient checked blood sugar (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score | 3 months follow up | change in number of days patient followed a foot care plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score | 3 months follow up | change in number of days patient followed a carb spacing plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Change in Summary of Diabetes Self-care Activities - Exercise Sub Score | 3 months follow up | change in number of days patient exercised (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up) |
| Change in Self-efficacy | 3 months after enrollment | Change Diabetes Empowerment Scale - Short Form( measures feelings of self efficacy regarding diabetes disease management) from baseline to 6 month follow up scale minimum 8, maximum 40 Best possible change 40 (maximum at follow up) minus 8 (minimum at follow up)=32 Worst possible change: -32 |
| Change in Problem Areas in Diabetes Scale | 3 months after enrollment | Change in Problem areas in diabetes scale (a measure of mental health problems that patient experience related to their diabetes) Baseline minus 3 month follow up. Higher score = more problems scale minimum 0 scale maximum 100 worst possible change -100 (0 problem scale at baseline, 100 at follow up) best possible change 100 (100 problem scale at baseline, 0 at follow up |
Countries
United States
Participant flow
Recruitment details
745 patients screened Excluded: * No mobile phone = 174 * Do not know how to text = 180 * HbA1c \<8 = 145 * No English or Spanish = 28 * Critically ill/AMS = 80 * Refused screening = 28
Pre-assignment details
14 patients dropped before randomization * Unable to identify support person = 4 * Unable to contact support person = 22 * Support person can not text = 15
Participants by arm
| Arm | Count |
|---|---|
| TExT-MED Only Patients will receive TExT-MED intervention, but supporters will not receive additional messages
TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone | 22 |
| TExT-MED FANS Patients get TExT-MED intervention, supporter gets FANS curriculum
TExT MED: educational , motivational, medication reminder and healthy living challenge text messages sent to patient's cell phone
FANS: supporter curriculum of messages, consisting of educational/motivational messages, and support challenges | 22 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 5 |
Baseline characteristics
| Characteristic | TExT-MED FANS | Total | TExT-MED Only |
|---|---|---|---|
| Age, Continuous | 46.04 years STANDARD_DEVIATION 9.86 | 46.05 years STANDARD_DEVIATION 9.45 | 46.05 years STANDARD_DEVIATION 9.17 |
| Language Both Equally | 1 Participants | 2 Participants | 1 Participants |
| Language More English than Spanish | 4 Participants | 6 Participants | 2 Participants |
| Language More Spanish than English | 3 Participants | 7 Participants | 4 Participants |
| Language Only English | 2 Participants | 4 Participants | 2 Participants |
| Language Only Spanish | 7 Participants | 18 Participants | 11 Participants |
| Race/Ethnicity, Customized African American | 1 Participants | 3 Participants | 2 Participants |
| Race/Ethnicity, Customized Asian | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Latino | 17 Participants | 35 Participants | 18 Participants |
| Race/Ethnicity, Customized Non-hispanic White | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Region of Enrollment United States | 22 Participants | 44 Participants | 22 Participants |
| Sex: Female, Male Female | 11 Participants | 25 Participants | 14 Participants |
| Sex: Female, Male Male | 11 Participants | 19 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 22 | 0 / 22 |
| other Total, other adverse events | 0 / 22 | 0 / 22 |
| serious Total, serious adverse events | 0 / 22 | 0 / 22 |
Outcome results
Primary
Acceptability
Patient response to: I have enjoyed the TExT-MED FANS (Trial to Examine Text-based mHealth for Emergency Department Patients With Diabetes With Family And Friend Network Supporter) program?
Time frame: 3 months after enrollment
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TExT-MED Only | Acceptability | Yes | 18 Participants |
| TExT-MED Only | Acceptability | No | 1 Participants |
| TExT-MED FANS | Acceptability | Yes | 17 Participants |
| TExT-MED FANS | Acceptability | No | 0 Participants |
Primary
Acceptability 2: Would Patients Recommend the Program to Family or Friends?
Response to: Would you recommend TExT-MED FANS to family or friends?
Time frame: 3 months follow up
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| TExT-MED Only | Acceptability 2: Would Patients Recommend the Program to Family or Friends? | Yes | 18 Participants |
| TExT-MED Only | Acceptability 2: Would Patients Recommend the Program to Family or Friends? | No | 1 Participants |
| TExT-MED FANS | Acceptability 2: Would Patients Recommend the Program to Family or Friends? | No | 0 Participants |
| TExT-MED FANS | Acceptability 2: Would Patients Recommend the Program to Family or Friends? | Yes | 17 Participants |
Primary
Feasibility
Number of patients lost to follow-up
Time frame: 3 months after enrollment
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| TExT-MED Only | Feasibility | 3 Participants |
| TExT-MED FANS | Feasibility | 5 Participants |
Secondary
Body Mass Index
height and weight measurements
Time frame: 3 months after enrollment
Population: Was not able to be collected
Secondary
Change in Problem Areas in Diabetes Scale
Change in Problem areas in diabetes scale (a measure of mental health problems that patient experience related to their diabetes) Baseline minus 3 month follow up. Higher score = more problems scale minimum 0 scale maximum 100 worst possible change -100 (0 problem scale at baseline, 100 at follow up) best possible change 100 (100 problem scale at baseline, 0 at follow up
Time frame: 3 months after enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Problem Areas in Diabetes Scale | -.9 units on a scale |
| TExT-MED FANS | Change in Problem Areas in Diabetes Scale | -6.8 units on a scale |
Secondary
Change in Self-efficacy
Change Diabetes Empowerment Scale - Short Form( measures feelings of self efficacy regarding diabetes disease management) from baseline to 6 month follow up scale minimum 8, maximum 40 Best possible change 40 (maximum at follow up) minus 8 (minimum at follow up)=32 Worst possible change: -32
Time frame: 3 months after enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Self-efficacy | .3 units on a scale |
| TExT-MED FANS | Change in Self-efficacy | 0.1 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score
change in number of days patient checked blood sugar (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score | -.7 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - Blood Glucose Sub Score | 1.6 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score
change in number of days patient followed a carb spacing plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score | 0.5 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - Carb Spacing Sub Score | 0.5 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - Exercise Sub Score
change in number of days patient exercised (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - Exercise Sub Score | 0.7 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - Exercise Sub Score | 0.4 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score
change in number of days patient followed a foot care plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score | 0.9 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - Foot Care Sub Score | 1 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - General Diet Sub Score
change in number of days patient followed a general diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - General Diet Sub Score | 0.1 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - General Diet Sub Score | 0.9 units on a scale |
Secondary
Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score
change in number of days patient followed a diabetes specific diet plan (3 month follow up report minus baseline report) Minimum -7: worst possible change (from all days at baseline to no days at follow up) Max 7: best possible change from baseline (from no days at baseline to all days at follow up)
Time frame: 3 months follow up
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score | 0.9 units on a scale |
| TExT-MED FANS | Change in Summary of Diabetes Self-care Activities - Specific Diet Sub Score | 1.2 units on a scale |
Secondary
Diabetes Knowledge Test Scale
Diabetes Knowledge Test Scale measures specific areas of diabetes knowledge, and is geared to specific curriculum
Time frame: 3 months after enrollment
Population: Data was not collected as final program educational curriculum did not have sufficient overlap with Diabetes Knowledge Test Scale
Secondary
Glycemic Control
glycosylated hemoglobin A1c
Time frame: 3 months after enrollment
| Arm | Measure | Value (MEAN) |
|---|---|---|
| TExT-MED Only | Glycemic Control | -0.6 % glycoslated hemoglobin |
| TExT-MED FANS | Glycemic Control | -1.4 % glycoslated hemoglobin |