Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes

Overview

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 a larger number of adult Haitian immigrants.

Full Title of Study: “Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Participant)
  • Study Primary Completion Date: January 31, 2024

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).

Interventions

  • Behavioral: Diabetes Self-Management Behaviors
    • The intervention is to be delivered by a diabetes educator.

Arms, Groups and Cohorts

  • Experimental: 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.
  • No Intervention: 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.

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • 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)
  • 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 Measures

  • Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
    • Time Frame: (T0) baseline through (T3) 90 days post-intervention
    • Change in diabetes distress ( 0-6, lower scores indicates improvement)

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 90 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Boston College
  • Collaborator
    • National Institute of Nursing Research (NINR)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Cherlie Magny-Normilus, Research Scholar – Boston College
  • Overall Official(s)
    • Cherlie Magny-Normilus, PhD, FNP-BC, Principal Investigator, Boston College
  • Overall Contact(s)
    • Cherlie Magny-Normilus, PhD, FNP-BC, 617-552-8814, cherlie.magny-normilus@bc.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.