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Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)

Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04023487
Acronym
REAL-T
Enrollment
209
Registered
2019-07-17
Start date
2019-10-22
Completion date
2023-11-18
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, randomized controlled trial

Brief summary

This study will evaluate (1) the efficacy of REAL-T, a lifestyle-based telehealth intervention, in improving glycemic control (HbA1c) and psychosocial outcomes, (2) which effects are retained over a 6-month follow-up period, and (3) the mediating mechanisms responsible for the intervention's effects. Half of participants will receive REAL-T, while the other half will receive their usual care.

Detailed description

Evaluation of a Complex Behavioral Intervention for Young Adults with Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study will address the unmet self-management and psychosocial needs of young adults (YAs) with type 1 diabetes (T1D). We will conduct a large-scale randomized controlled trial (n=210) to compare the 6-month REAL-T intervention to usual care in improving glycemic control (A1c and continuous glucose monitor-derived measures), psychosocial well-being, and hypothesized intervention mediators. In addition, we will perform health economic analyses to determine the extent to which REAL-T is cost-effective or produces cost savings. The study's specific aims are as follows: Aim 1: Evaluate the efficacy of REAL-T in improving glycemic control and psychosocial well-being. * Hypothesis 1: Over a 6-month intervention period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate improvements in glycemic control, in comparison to YAs with T1D who receive usual care. * Hypothesis 2: Over a 6-month period (including 3 and 6 month measures), YAs with T1D who receive REAL-T demonstrate gains in psychosocial well-being in comparison to YAs with T1D who receive usual care. Aim 2: Assess the post-intervention durability (at 3 and 6 months post-intervention) of REAL-T's effects on glycemic control and psychosocial well-being. * Hypothesis 1: Among YAs with T1D, improvements in glycemic control that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment. * Hypothesis 2: Among YAs with T1D, improvements in psychosocial well-being that result from REAL-T relative to usual care are maintained at 3 and 6 months post-treatment. Aim 3: Examine mediating mechanisms of the REAL-T intervention's effects on glycemic control and psychosocial well-being through structural equation modeling (SEM). * Hypothesis 1: Improvements in diabetes self-care behaviors mediate positive intervention effects on glycemic control and psychosocial well-being. * Hypothesis 2: Improvements in self-efficacy mediate positive intervention effects on psychosocial well-being and partially mediate positive effects on diabetes self-care behaviors. * Hypothesis 3: Improvements in habit strength for diabetes self-care behaviors partially mediate positive intervention effects on the performance of diabetes self-care behaviors.

Interventions

BEHAVIORALResilient, Empowered, Active Living-Telehealth (REAL-T)

REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.

Sponsors

University of Southern California
Lead SponsorOTHER
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CollaboratorNIH

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 30 Years
Healthy volunteers
No

Inclusion criteria

* T1D for ≥12 months * A1c ≥7.5% at time of study enrollment * Age 18-30 yrs. at time of study enrollment * English or Spanish speaking * Resides in a state where OT clinicians are licensed, in an area where the participant has access to a local healthcare provider in the event of emergency and can complete data collection in person (when permitted) or via mailings (when required during period of social distance or due to distance from study site) * Participant has access to a laptop or desktop computer, either their own or loaned by the study (if geographically feasible and permitted given COVID-19 social distancing distractions) * Willing to participate in 6-month intervention

Exclusion criteria

* Currently pregnant or planning to become pregnant within the next 12 months * Previously received REAL intervention * Cognitive impairment or severe disability limiting life expectancy

Design outcomes

Primary

MeasureTime frameDescription
Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)Assessed at Baseline and 6 months; change from baseline to 6 months reportedHbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported.

Secondary

MeasureTime frameDescription
Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15)Assessed at Baseline and 6 months; change from baseline to 6 months reported15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: "If I did not have diabetes, \[the question topic\] would be", followed by 5 options ranging from "very much better" (or similar; scored as -3) to "worse" (or similar; scored as 1). The fourth option is always "the same" and scored as 0. Part B is: "\[the question topic\] is" followed by 4 options ranging from "very important" (scored as 3) to "not at all important" (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, \& 11 have preliminary yes/no questions, and when a "no" response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Higher/more positive scores represent a better outcome; Lower/ more negative scores represent a worse outcome.
Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS)Assessed at Baseline and 6 months; change from baseline to 6 months reported17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6, with higher scores indicating a worse outcome. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6, with higher scores indicating a worse outcome. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score \> 3.0 should be considered 'high distress.'
Change From Baseline to 6-months in Functional Health and Well-being, Using the "SF-12v2® Health Survey"Assessed at Baseline, 6 months, and 12 months; change from baseline to 6 months reportedShort Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health \& well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states.
Change From Baseline to 6-months in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10.
Change From Baseline to 6-months in Medication Adherence, Using the "3-item Adherence Self-report Scale" QuestionnaireAssessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported3-item questionnaire (Wilson,Lee, Fowler, \& Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100.
Change From Baseline to 6-months in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF)Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy.
Change From Baseline to 6-months in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ)Assessed at Baseline, 3 months, 6 months, 9 months, and 12 months; change from baseline to 6 months reported19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-RangeAssessed at Baseline and 6 months; change from baseline to 6 months reportedThe percentage of time when blood glucose was between 70 and 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in HyperglycemiaAssessed at Baseline and 6 months; change from baseline to 6 months reportedThe percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.
Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in HypoglycemiaAssessed at Baseline and 6 months; change from baseline to 6 months reportedThe percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORElizabeth Pyatak, PhD, OTR/L

University of Southern California

Participant flow

Participants by arm

ArmCount
Lifestyle Intervention
Resilient, Empowered, Active Living-Telehealth (REAL-T) Resilient, Empowered, Active Living-Telehealth (REAL-T): REAL-T is an individually-tailored occupational therapy intervention that focuses on incorporating diabetes self-care into participants' daily habits and routines. Participants receive approximately 12 hours of intervention, delivered via telehealth over 6 months by a licensed occupational therapist with training in diabetes education, motivational interviewing, and the REAL Diabetes intervention protocol.
104
Usual Care
Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
105
Total209

Baseline characteristics

CharacteristicLifestyle InterventionUsual CareTotal
Age, Continuous23.88 years
STANDARD_DEVIATION 3.78
24.77 years
STANDARD_DEVIATION 3.62
24.33 years
STANDARD_DEVIATION 3.72
Baseline A1c9.12 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.44
9.26 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.66
9.19 percentage of glycosylated hemoglobin
STANDARD_DEVIATION 1.55
Diabetes device use
Injections + CGM
27 Participants20 Participants47 Participants
Diabetes device use
Injections only
30 Participants29 Participants59 Participants
Diabetes device use
Insulin pump only
12 Participants13 Participants25 Participants
Diabetes device use
Other combination
2 Participants5 Participants7 Participants
Diabetes device use
Pump + CGM
33 Participants38 Participants71 Participants
Educational Attainment
Bachelor's Degree
17 Participants31 Participants48 Participants
Educational Attainment
Decline to Answer
1 Participants0 Participants1 Participants
Educational Attainment
Graduate Degree
6 Participants12 Participants18 Participants
Educational Attainment
High School Graduate
26 Participants19 Participants45 Participants
Educational Attainment
Some college/AA degree
51 Participants38 Participants89 Participants
Educational Attainment
Some High School
3 Participants5 Participants8 Participants
Employment Status (non-exclusive)
Disabled
3 Participants3 Participants6 Participants
Employment Status (non-exclusive)
Full-time homemaker
3 Participants5 Participants8 Participants
Employment Status (non-exclusive)
Full-time work
42 Participants48 Participants90 Participants
Employment Status (non-exclusive)
On leave
5 Participants3 Participants8 Participants
Employment Status (non-exclusive)
Other/decline to answer
3 Participants4 Participants7 Participants
Employment Status (non-exclusive)
Part-time work
26 Participants25 Participants51 Participants
Employment Status (non-exclusive)
Student
37 Participants34 Participants71 Participants
Employment Status (non-exclusive)
Unemployed
10 Participants10 Participants20 Participants
Health Insurance (non-exclusive)
Decline to answer
1 Participants1 Participants2 Participants
Health Insurance (non-exclusive)
Don't know
7 Participants2 Participants9 Participants
Health Insurance (non-exclusive)
MediCal/Medicaid
38 Participants43 Participants81 Participants
Health Insurance (non-exclusive)
No Insurance
2 Participants2 Participants4 Participants
Health Insurance (non-exclusive)
Other public insurance
13 Participants5 Participants18 Participants
Health Insurance (non-exclusive)
Private
53 Participants57 Participants110 Participants
Household composition (non-exclusive)
Alone
1 Participants4 Participants5 Participants
Household composition (non-exclusive)
Missing/Declined to State
0 Participants1 Participants1 Participants
Household composition (non-exclusive)
With parents
50 Participants44 Participants94 Participants
Household composition (non-exclusive)
With partner
39 Participants34 Participants73 Participants
Household composition (non-exclusive)
With roommates
21 Participants22 Participants43 Participants
Household size3.62 Persons
STANDARD_DEVIATION 1.81
3.65 Persons
STANDARD_DEVIATION 2
3.63 Persons
STANDARD_DEVIATION 1.91
Race/Ethnicity, Customized
>1 Race/ethnicity
5 Participants3 Participants8 Participants
Race/Ethnicity, Customized
Asian
2 Participants2 Participants4 Participants
Race/Ethnicity, Customized
Black
1 Participants7 Participants8 Participants
Race/Ethnicity, Customized
Decline to Answer
1 Participants0 Participants1 Participants
Race/Ethnicity, Customized
Hispanic/Latinx
49 Participants42 Participants91 Participants
Race/Ethnicity, Customized
Other
0 Participants4 Participants4 Participants
Race/Ethnicity, Customized
White
46 Participants47 Participants93 Participants
Recruitment Source
Clinic
40 Participants42 Participants82 Participants
Recruitment Source
Social Media (California)
40 Participants40 Participants80 Participants
Recruitment Source
Social Media (Oregon, Washington, Colorado)
10 Participants7 Participants17 Participants
Recruitment Source
Social Media (Texas)
14 Participants16 Participants30 Participants
Region of Enrollment
United States
104 participants105 participants209 participants
Sex/Gender, Customized
Decline to Answer
1 Participants0 Participants1 Participants
Sex/Gender, Customized
Female
62 Participants63 Participants125 Participants
Sex/Gender, Customized
Male
36 Participants39 Participants75 Participants
Sex/Gender, Customized
Other
5 Participants3 Participants8 Participants
Social Deprivation Index (SDI)63.11 units on a scale
STANDARD_DEVIATION 27.99
63.92 units on a scale
STANDARD_DEVIATION 27.04
63.52 units on a scale
STANDARD_DEVIATION 27.46
Social Needs2.13 units on a scale
STANDARD_DEVIATION 1.87
2.07 units on a scale
STANDARD_DEVIATION 1.8
2.10 units on a scale
STANDARD_DEVIATION 1.83
Social Vulnerability Index (SVI)0.57 units on a scale
STANDARD_DEVIATION 0.28
0.55 units on a scale
STANDARD_DEVIATION 0.29
0.56 units on a scale
STANDARD_DEVIATION 0.29
T1D diagnosis age10.77 years
STANDARD_DEVIATION 6.01
12.22 years
STANDARD_DEVIATION 5.94
11.50 years
STANDARD_DEVIATION 6

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 1040 / 105
other
Total, other adverse events
8 / 1047 / 105
serious
Total, serious adverse events
34 / 10428 / 105

Outcome results

Primary

Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)

HbA1C is a measure of average blood glucose concentration over approximately the previous 12 weeks. HbA1C will be measured using a finger-prick test using the DCA Vantage Analyzer point-of-care system OR AccuBase A1c test with DTI Laboratories. Assessed at Baseline and 6 months; change from baseline to 6 months reported.

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)-0.44 percentage of glycosylated hemoglobinStandard Deviation 1.22
Usual CareChange From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)-0.31 percentage of glycosylated hemoglobinStandard Deviation 1.35
Secondary

Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the Diabetes Distress Scale (DDS)

17-item questionnaire assessing diabetes-related emotional distress. Total scores (mean score on all 17 items) range from 1 to 6, with higher scores indicating a worse outcome. Sub-scale scores (emotional burden, physician-related distress, regimen-related distress, and interpersonal distress) each range from 1 to 6, with higher scores indicating a worse outcome. A total or sub-scale score 2.0 - 2.9 should be considered 'moderate distress,' and a total or sub-scale score \> 3.0 should be considered 'high distress.'

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the Diabetes Distress Scale (DDS)-0.48 score on a scaleStandard Deviation 1.01
Usual CareChange From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the Diabetes Distress Scale (DDS)-0.25 score on a scaleStandard Deviation 1.07
Secondary

Change From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the Audit of Diabetes-Dependent Quality of Life-15 (ADD-QoL-15)

15-item questionnaire assessing diabetes-related quality of life (qol). Each item contains two parts. Part A is: If I did not have diabetes, \[the question topic\] would be, followed by 5 options ranging from very much better (or similar; scored as -3) to worse (or similar; scored as 1). The fourth option is always the same and scored as 0. Part B is: \[the question topic\] is followed by 4 options ranging from very important (scored as 3) to not at all important (scored as 0). For each question, scores on parts A and B are multiplied, and the 15 products are summed for a total score. Questions 2, 4, 6, 8, 9, & 11 have preliminary yes/no questions, and when a no response is given, parts A and B are skipped and the score for that question is 0. The minimum score on each question is -9 and the maximum is 3, with total scores ranging from -135 to 45. Higher/more positive scores represent a better outcome; Lower/ more negative scores represent a worse outcome.

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the Audit of Diabetes-Dependent Quality of Life-15 (ADD-QoL-15)0.39 score on a scaleStandard Deviation 1.37
Usual CareChange From Baseline to 6-months Post-test in Diabetes-related Quality of Life, Using the Audit of Diabetes-Dependent Quality of Life-15 (ADD-QoL-15)-0.15 score on a scaleStandard Deviation 1.59
Secondary

Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia

The percentage of time when blood glucose was above 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia-4.48 percentage of timeStandard Deviation 24.68
Usual CareChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia-1.61 percentage of timeStandard Deviation 26.5
Secondary

Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia

The percentage of time when blood glucose was below 70 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia0.04 percentage of timeStandard Deviation 4.99
Usual CareChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia0.59 percentage of timeStandard Deviation 5.09
Secondary

Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range

The percentage of time when blood glucose was between 70 and 180 mg/dl, as measured by a continuous glucose monitor worn for 14 days.

Time frame: Assessed at Baseline and 6 months; change from baseline to 6 months reported

ArmMeasureValue (MEAN)Dispersion
Lifestyle InterventionChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range4.44 percentage of timeStandard Deviation 22.18
Usual CareChange From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range1.02 percentage of timeStandard Deviation 24.02
Secondary

Change in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the Treatment Self-Regulation Questionnaire (TSRQ)

19-item questionnaire, adapted for type 1 diabetes, assessing the degree to which a person's motivation for a particular behavior or a set of behaviors is relatively autonomous or self-determined. Each item can receive a value ranging from 1 - 7 as selected by the participant. The scale has 2 sub-scales: the autonomous regulatory style and the controlled regulatory style. Calculating the scores for the sub-scales consists of averaging the items on that sub-scale. A Relative Autonomous Motivation Index can be formed by subtracting the average for the controlled reasons from the average for the autonomous reasons. Scores range from 1 to 7, with 7 indicating a strong identification with the given autonomy style. The autonomous regulatory style represents the most self-determined form of motivation.

Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary

Change in Cost to Patients

9 diabetes-related expense questions designed by the study (polar questions, multiple choice, and open-ended). Questions assess loss of income or other productivity due to diabetes (3 items), and impact of cost and health insurance on access to and use of insulin and test strips (6 items).

Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary

Change in Cost to Payor

8-item healthcare utilization questionnaire designed by the study. Polar; Yes/No questions about health service usage in the last month: (e.g., have you had to be admitted to the hospital?). Open-ended questions about number of time health services were used, (e.g., how many times were you admitted to the hospital for reasons related to diabetes?).

Time frame: Baseline, 1 month, 2 months, 3 months, 4 months, 5 months, 6 months, 7 months, 8 months, 9 months, 10 months, 11 months, and 12 months

Secondary

Change in Functional Health and Well-being, Using the SF-12v2® Health Survey

Short Form 12-item Health Survey Ver. 2 (SF-12v2) is a 12-item questionnaire assessing functional health & well-being over the last 4 weeks in 8 health domains (physical functioning, role participation with physical health problems, bodily pain, general health, vitality, social functioning, role participation with emotional health problems, mental health), all from the patient's point of view. These 8 domains can be summarized into a physical component summary (PCS) and a mental component summary (MCS). Higher scores indicate a better health state. MCS and PCS scores range from 0-100. Scores are calibrated using general population-derived normative data so that 50 is the avg score or norm. Results can be further summarized into a single preference-based health utility number ranging from 1 (equivalent to perfect health) to 0 (equivalent to being dead), using a complex scoring algorithm (SF-6D) derived from surveying a general U.S. population's preferences for specific health states.

Time frame: Baseline, 6 months, and 12 months

Secondary

Change in Global Diabetes Self-management, Using the Diabetes Self-Management Questionnaire-Revised (DSMQ-R).

27-item questionnaire assessing self-care activities associated with glycemic control. Higher values indicate more effective self-management. Transformed scores = Actual sum of items / maximum possible sum of items x 10. Total transformed scores range from 0 to 10. Transformed scores on six sub-scales (Dietary control, Glucose management, Glucose monitoring, Medication adherence, Physical activity, and Physician contact) also range from 0 to 10.

Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary

Change in Medication Adherence, Using the 3-item Adherence Self-report Scale Questionnaire

3-item questionnaire (Wilson,Lee, Fowler, & Rogers, 2016) assessing adherence to diabetes medication regimen. Item responses for the three adherence items are linearly transformed to a 0-100 scale with zero being the worst adherence, and 100 the best. A total summary score is calculated as the mean of the three individual items, with a range of 0 to 100.

Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

Secondary

Change in Self-efficacy for Performing Diabetes Self-management, Using the Diabetes Empowerment Scale - Short Form (DES-SF)

8-item questionnaire assessing self-efficacy for performing diabetes self-management, using 5-point likert scales. The scale is scored by averaging the scores of all completed items. Scores range from 8 to 40, with higher scores indicating higher self-efficacy.

Time frame: Baseline, 3 months, 6 months, 9 months, and 12 months

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026