Overview

This trial is active, not recruiting.

Conditions diabetes mellitus, type 1, diabetes mellitus, type 2
Treatments resilient, empowered, active living with diabetes, information control
Sponsor University of Southern California
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date October 2014
End date July 2016
Trial size 81 participants
Trial identifier NCT02214641, 1K01DK099202-01A1

Summary

This three-year award will pilot-test an innovative intervention, Resilient, Empowered, Active Living with Diabetes (REAL), targeting underserved minority young adults with poorly-controlled diabetes. The individually tailored, community-based intervention merges findings of an in-depth needs assessment, principles of an evidence-based occupational therapy intervention (Lifestyle Redesign®) and evidence-based diabetes self-management strategies. A proof-of-concept study demonstrated that REAL is feasible to implement, acceptable to young adults with type 1 diabetes and type 2 diabetes, and has potential to produce positive changes in diabetes self-care and glycemic control. The study will randomize 80 young adults with diabetes to receive either the six-month REAL intervention or an attention control condition. Blinded data collectors will assess glycemic control, diabetes self-care behaviors and quality of life outcomes, as well as potential intervention mediators, before and after the six-month intervention. It is anticipated that findings from this pilot study will be used to inform a large-scale randomized controlled trial of the REAL intervention.

The study's specific aims and hypotheses are as follows:

Aim 1. Determine the intervention's efficacy for the primary outcomes: glycemic control and diabetes self-care.

Hypothesis: At 6 months (immediately following the intervention), intervention group participants will demonstrate improvements in A1C and diabetes self-care as compared to control group participants.

Aim 2. Conduct exploratory analyses of the intervention's impact on secondary outcomes and potential mediating mechanisms (to inform power estimates for a large-scale RCT).

Hypothesis 1: At 6 months, intervention group participants will demonstrate improvements in secondary outcomes: diabetes-related stress and quality of life, depression, and life satisfaction as compared to control group participants.

Hypothesis 2: At 6 months, intervention group participants will demonstrate improvements in potential mediators of the intervention: habit strength, problem solving, activity participation, self-efficacy and diabetes knowledge as compared to baseline.

Aim 3. Conduct a process evaluation utilizing mixed methods to evaluate and refine intervention delivery (e.g. treatment fidelity, patient satisfaction) and study procedures (e.g. recruitment, retention, testing protocol).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Resilient, Empowered, Active Living (REAL) Diabetes
resilient, empowered, active living with diabetes
Individualized lifestyle intervention incorporating the following topics: Diabetes knowledge; access to healthcare; communication with healthcare providers; incorporation of diabetes self-care tasks within daily habits and routines; social support; and emotional well-being. Participants receive a total of 10-16 hours of intervention by a licensed occupational therapist with training in diabetes education, motivational interviewing and the REAL Diabetes intervention protocol.
(Active Comparator)
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose.
information control
Participants will receive a packet of informational materials about diabetes, and receive periodic follow-up phone calls to match for attention dose. The packet of materials will be delivered in an initial home visit. Follow-up phone calls will occur at approximately two week intervals to inquire whether participants have reviewed specific sections of the intervention materials, and clarify information included in the packet.

Primary Outcomes

Measure
Glycated hemoglobin (HbA1C)
time frame: Baseline & 6 months.

Secondary Outcomes

Measure
Audit of Diabetes-Dependent Quality of Life (ADD-QoL)
time frame: Baseline & 6 months.
Problem Areas in Diabetes (PAID) Scale - Short Form
time frame: Baseline & 6 months.
Patient Health Questionnaire-8 (PHQ-8)
time frame: Baseline & 6 months
Satisfaction With Life Scale (SWLS)
time frame: Baseline & 6 months.
Summary of Diabetes Self-Care Activities (SDSCA)
time frame: Baseline & 6 months

Eligibility Criteria

Male or female participants from 18 years up to 30 years old.

Inclusion Criteria: - Diagnosed with type 1 or type 2 diabetes mellitus for a minimum of 12 months - Most recent A1C ≥8.0% - Fluent in English or Spanish - Reachable by telephone or text message - Willing to participate in study activities - Reside in Los Angeles County with no plans to relocate Exclusion Criteria: - Pregnant or planning to become pregnant - Cognitive impairment or severe disability limiting life expectancy - Participated in lifestyle intervention targeting diabetes within past 12 months - Participated in formative research related to intervention development.

Additional Information

Official title Diabetes Self-Management Lifestyle Intervention for Urban Minority Young Adults
Principal investigator Elizabeth Pyatak, PhD, OTR/L
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Southern California.