Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- New York University
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Stanford Diabetes Self-Efficacy Scale (8- item)
Study Overview
Brief Summary
The objective of the study is to conduct a pilot randomized study to test feasibility and preliminary efficacy of the developed diabetes self-management education program with 40 adult Haitian immigrants.
Detailed Description
This is a two-arm randomized trial. Participants will be randomized to the culturally tailored Diabetes Self-Management Education Program or standard care condition in a 1:1 allocation. All participants will receive standard type 2 diabetes care at the enrolled clinic and remain under their providers' care for the duration of the study. The culturally tailored Diabetes Education Program involves the following: 1) an initial 45-minute face-to-face consultation; and 2) six 2-hour weekly interactive educational sessions in a format to be determined (TBD) by Aim 1 (e.g., in-person, video/telephone conference call).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Masking Description
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Self-described Haitian immigrant aged 21 and older
- •Known diagnosis of type 2 diabetes for at least one year
- •Have lived in the US for at least one year
- •Have an HbA1c of 7.5%
- •Willing and able to participate in an individual interview
Exclusion Criteria
- •Having a diagnosis of type 1 diabetes
- •Unable to comprehend, consent and or fully participate in the study
Arms & Interventions
Usual Type 2 Diabetes Care
The usual care arm will receive the clinic's standard type 2 diabetes care and remain under their providers' care for the duration of the study.
Diabetes Self-Management Behaviors
Self-Management Education Program The culturally tailored Diabetes Self-Management Education Program involves the following: 1) an initial 45-minute face-to-face private consultation collaboratively determining goals; followed by 2) six 2-hour weekly educational interactive sessions in a format TBD by aim 1. We will deliver culturally targeted written materials and presentations in these sessions. Participants will be asked to practice self-management behaviors concurrently and for four additional weeks.
Intervention: Diabetes Self-Management Behaviors (Behavioral)
Outcomes
Primary Outcomes
Stanford Diabetes Self-Efficacy Scale (8- item)
Time Frame: (T0) baseline through (T3) 90 days post-intervention
Change in general self-efficacy 1-10, higher scores indicate improvement)
Wrist-worn actigraphy (ActiGraph) to be worn while awake
Time Frame: (T0) baseline through (T3) 90 days post-intervention
Change in physical activity (Frequent physical activity indicates improvement)
Summary of Diabetes of Self-Care Activities Scale (11- item)
Time Frame: (T0) baseline through (T3) 90 days post-intervention
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
Time Frame: (T0) baseline through (T3) 90 days post-intervention
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
Secondary Outcomes
- Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6((T0) baseline through (T3) 90 days post-intervention)