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

Diabetes Mellitus, Type 2 Clinical Trial

Official title:

Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04949568
• Other study ID #: 20.236.01
• Status: Recruiting
• Phase: N/A
• Start date: August 12, 2023
• Est. completion date: July 31, 2025

Study information

• Verified date: May 2024
• Source: Boston College
• Contact: Cherlie Magny-Normilus, PhD, FNP-BC
• Phone: 617-552-8814
• Email: cherlie.magny-normilus[@]bc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 a larger number of adult Haitian immigrants.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: July 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Patient Education
• Patient Engagement

Intervention

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

Locations

Country	Name	City	State
United States	Boston College	Chestnut Hill	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston College	National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Summary of Diabetes of Self-Care Activities Scale (11- item)	Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)	(T0) baseline through (T3) 90 days post-intervention
Primary	Stanford Diabetes Self-Efficacy Scale (8- item)	Change in general self-efficacy 1-10, higher scores indicate improvement)	(T0) baseline through (T3) 90 days post-intervention
Primary	Wrist-worn actigraphy (ActiGraph) to be worn while awake	Change in physical activity (Frequent physical activity indicates improvement)	(T0) baseline through (T3) 90 days post-intervention
Primary	Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro	Time in range and glucose variability (More time in range and less glucose variability indicates improvement)	(T0) baseline through (T3) 90 days post-intervention
Secondary	Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6	Change in diabetes distress ( 0-6, lower scores indicates improvement)	(T0) baseline through (T3) 90 days post-intervention