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

NCT04023487 | Completed Results DMC

• 1 other identifier: 1R01DK116719
• Study Type: interventional
• Target: 209
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1, randomized controlled trial

Outcome Measures

Primary Outcomes (1)

• 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.

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

Secondary Outcomes (12)

• 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 reported

• 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 reported

• 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

Study Arms (2)

Lifestyle Intervention

EXPERIMENTAL

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

Behavioral: Resilient, Empowered, Active Living-Telehealth (REAL-T)

Usual Care

NO INTERVENTION

Participants will continue to have access to routine diabetes care from the provider of their choosing; they will not receive any study-related intervention.

Interventions

Resilient, Empowered, Active Living-Telehealth (REAL-T) BEHAVIORAL

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.

Lifestyle Intervention

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

USC Center for Health Professionals

Los Angeles, California, 90033, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

COVID-19/public health policies may have affected data. COVID-19 led to changes in outcome assessment methods (in-person vs self-administered surveys; Afinion POC vs AccuBase mail-in A1c test) and caused other logistical challenges affecting data collection.

Results Point of Contact

• Title: Beth Pyatak
• Organization: University of Southern California

beth.pyatak@chan.usc.edu

323-442-2615

Study Officials

• Elizabeth Pyatak, PhD, OTR/L

  University of Southern California

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 15, 2019
• First Posted: July 17, 2019
• Study Start: October 22, 2019
• Primary Completion: June 5, 2023
• Study Completion: November 18, 2023
• Last Updated: August 21, 2024
• Results First Posted: August 21, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)