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

New York University (NYU)

Status: Active, not recruiting

Conditions: Patient Education; Diabetes Mellitus, Type 2; Patient Engagement

Treatments: Behavioral: Diabetes Self-Management Behaviors

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04949568

2024-9103

Details and patient eligibility

About

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.

Full 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).

Enrollment: 40 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

Diabetes Self-Management Behaviors

Experimental group

Description:

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.

Treatment:

Behavioral: Diabetes Self-Management Behaviors

Usual Type 2 Diabetes Care

No Intervention group

Description:

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.