Evaluation of a Complex Intervention for Young Adults With Diabetes: The Resilient, Empowered, Active Living-Telehealth (REAL-T) Study
Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)
Sponsors
Source
University of Southern California
Oversight Info
Has Dmc
Yes
Is Fda Regulated Drug
No
Is Fda Regulated Device
No
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.
Overall Status
Recruiting
Start Date
2019-10-01
Completion Date
2022-12-01
Primary Completion Date
2022-06-01
Phase
N/A
Study Type
Interventional
Primary Outcome
Measure |
Time Frame |
|
Change in glycemic control, using Glycated Hemoglobin (HbA1C) |
Baseline, 3 months, 6 months, 9 months, and 12 months |
Secondary Outcome
Measure |
Time Frame |
|
Change in diabetes-related quality of life, using the "Audit of Diabetes-Dependent Quality of Life-15" (ADD-QoL-15) |
Baseline, 6 months, and 12 months |
|
Change in diabetes-related emotional distress, using the "Diabetes Distress Scale" (DDS) |
Baseline, 6 months, and 12 months |
|
Change in functional health and well-being, using the "SF-12v2® Health Survey" |
Baseline, 6 months, and 12 months |
|
Change in global diabetes self-management, using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R). |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in medication adherence, using the "3-item adherence self-report scale" questionnaire |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in automaticity of behavior (testing blood sugar), using the "Self-Report Behavioural Automaticity Index" (SRBAI) |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in self-efficacy for performing diabetes self-management, using the "Diabetes Empowerment Scale - Short Form" (DES-SF) |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in autonomy of taking insulin and/or checking blood sugar, using the "Treatment Self-Regulation Questionnaire" (TSRQ) |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in cost to patients |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in self management of blood glucose, using the # of blood glucose checks |
Baseline, 3 months, 6 months, 9 months, and 12 months |
|
Change in glycemic control, using Percent Time-in-Range |
Baseline, 6 months, and 12 months |
|
Change in glycemic control, using Percent Time in Hyperglycemia |
Baseline, 6 months, and 12 months |
|
Change in glycemic control, using Percent Time in Hypoglycemia |
Baseline, 6 months, and 12 months |
|
Telehealth Satisfaction |
6 months |
|
Change in cost to payor |
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 |
Enrollment
210
Condition
Intervention
Intervention Type
Behavioral
Intervention Name
Description
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.
Arm Group Label
Lifestyle Intervention
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 within 50 miles of study office with no plans to relocate
- 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
Gender
All
Minimum Age
18 Years
Maximum Age
30 Years
Healthy Volunteers
No
Overall Official
Last Name |
Role |
Affiliation |
|
Elizabeth Pyatak, PhD, OTR/L |
Principal Investigator |
University of Southern California |
Overall Contact
Location
Facility |
Status |
Contact |
|
USC Center for Health Professionals Los Angeles California 90033 United States |
Recruiting |
Location Countries
Country
United States
Verification Date
2019-10-01
Lastchanged Date
N/A
Firstreceived Date
N/A
Responsible Party
Responsible Party Type
Principal Investigator
Investigator Affiliation
University of Southern California
Investigator Full Name
Beth Pyatak
Investigator Title
Associate Professor
Keyword
Has Expanded Access
No
Condition Browse
Secondary Id
1R01DK116719
Number Of Arms
2
Arm Group
Arm Group Label
Lifestyle Intervention
Arm Group Type
Experimental
Description
Resilient, Empowered, Active Living-Telehealth (REAL-T)
Arm Group Label
Usual Care
Arm Group Type
No Intervention
Description
Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.
Firstreceived Results Date
N/A
Overall Contact Backup
Acronym
REAL-T
Other Outcome
Measure
Background Information
Time Frame
Baseline
Description
19-item questionnaire, designed by the study, gathering background data on demographic characteristics and baseline healthcare utilization (for prior 3 months). No total score will be calculated. Scores on individual items will be used as covariates in various analyses.
Patient Data
Sharing Ipd
No
Firstreceived Results Disposition Date
N/A
Study Design Info
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)
Study First Submitted
July 15, 2019
Study First Submitted Qc
July 15, 2019
Study First Posted
July 17, 2019
Last Update Submitted
October 2, 2019
Last Update Submitted Qc
October 2, 2019
Last Update Posted
October 4, 2019
ClinicalTrials.gov processed this data on December 10, 2019
Conditions
Conditions usually refer to a disease, disorder, syndrome, illness, or injury. In ClinicalTrials.gov,
conditions include any health issue worth studying, such as lifespan, quality of life, health risks, etc.
Interventions
Interventions refer to the drug, vaccine, procedure, device, or other potential treatment being studied.
Interventions can also include less intrusive possibilities such as surveys, education, and interviews.
Study Phase
Most clinical trials are designated as phase 1, 2, 3, or 4, based on the type of questions
that study is seeking to answer:
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.
In Phase 1 (Phase I) clinical trials, researchers test a new drug or treatment in a small group of people (20-80) for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
In Phase 2 (Phase II) clinical trials, the study drug or treatment is given to a larger group of people (100-300) to see if it is effective and to further evaluate its safety.
In Phase 3 (Phase III) clinical trials, the study drug or treatment is given to large groups of people (1,000-3,000) to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
In Phase 4 (Phase IV) clinical trials, post marketing studies delineate additional information including the drug's risks, benefits, and optimal use.
These phases are defined by the Food and Drug Administration in the Code of Federal Regulations.