N/A
Completed N=209
Evaluation of an Intervention for Young Adults With Diabetes: Resilient, Empowered, Active Living-Telehealth (REAL-T)
Diabetes Mellitus, Type 1
Source: ClinicalTrials.gov NCT04023487 ↗
Enrolled (actual)
209
Serious AEs
29.7%
Results posted
Aug 2024
Primary outcomePrimary: Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C) — -0.44; -0.31 percentage of glycosylated hemoglobin
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to 6-months in Glycemic Control, Using Glycated Hemoglobin (HbA1C) |
-0.44; -0.31 | — |
| 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) |
0.39; -0.15 | — |
| SECONDARY Change From Baseline to 6-months Post-test in Diabetes-related Emotional Distress, Using the "Diabetes Distress Scale" (DDS) |
-0.48; -0.25 | — |
| SECONDARY Change in Functional Health and Well-being, Using the "SF-12v2® Health Survey" |
— | — |
| SECONDARY Change in Global Diabetes Self-management, Using the "Diabetes Self-Management Questionnaire-Revised" (DSMQ-R). |
— | — |
| SECONDARY Change in Medication Adherence, Using the "3-item Adherence Self-report Scale" Questionnaire |
— | — |
| SECONDARY Change in Self-efficacy for Performing Diabetes Self-management, Using the "Diabetes Empowerment Scale - Short Form" (DES-SF) |
— | — |
| SECONDARY Change in Autonomy of Taking Insulin and/or Checking Blood Sugar, Using the "Treatment Self-Regulation Questionnaire" (TSRQ) |
— | — |
| SECONDARY Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time-in-Range |
4.44; 1.02 | — |
| SECONDARY Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hyperglycemia |
-4.48; -1.61 | — |
| SECONDARY Change From Baseline to 6-months Post-test in Glycemia, Using Percent Time in Hypoglycemia |
0.04; 0.59 | — |
| SECONDARY Change in Cost to Patients |
— | — |
| SECONDARY Change in Cost to Payor |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT04023487). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.