Clinical trial NCT04023487: Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)
Official title: Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus, Type 1, randomized controlled trial
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2019-07-17
Enrollment: 209
Sex: ALL
Minimum age (years): 18
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C)
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
Secondary outcomes:
measure: 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)
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
measure: Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS)
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
measure: Change in Functional Health and Well-being, Using the "SF-12v2® Health Survey"
timeFrame: Baseline, 6 months, and 12 months
measure: Change in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R).
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Change in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Change in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF)
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Change in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ)
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
measure: Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
measure: Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia
timeFrame: Assessed at Baseline and 6 months; change from baseline to 6 months reported
measure: Change in Cost to Patients
timeFrame: Baseline, 3 months, 6 months, 9 months, and 12 months
measure: Change in Cost to Payor
timeFrame: 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
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: USC Center for Health Professionals
state: California
Study officials:
affiliation: University of Southern California
name: Elizabeth Pyatak, PhD, OTR/L
role: PRINCIPAL_INVESTIGATOR
References: