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

Sponsor
Boston College (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04949568
Collaborator
National Institute of Nursing Research (NINR) (NIH), National Institutes of Health (NIH) (NIH)
40
Enrollment
1
Location
2
Arms
24
Anticipated Duration (Months)
1.7
Patients Per Site Per Month

Study Details

Study Description

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 a larger number of adult Haitian immigrants.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Diabetes Self-Management Behaviors
 N/A

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
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Behavioral: Diabetes Self-management behaviorsBehavioral: Diabetes Self-management behaviors
Masking:
Single (Participant)
Masking Description:
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
Primary Purpose:
Supportive Care
Official Title:
Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
Anticipated Study Start Date :
Aug 1, 2023
Anticipated Primary Completion Date :
Jan 31, 2024
Anticipated Study Completion Date :
Jul 31, 2025

Arms and Interventions

Arm Intervention/Treatment
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.

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

Outcome Measures

Primary Outcome Measures

  1. Summary of Diabetes of Self-Care Activities Scale (11- item) [(T0) baseline through (T3) 90 days post-intervention]

    Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)

  2. Stanford Diabetes Self-Efficacy Scale (8- item) [(T0) baseline through (T3) 90 days post-intervention]

    Change in general self-efficacy 1-10, higher scores indicate improvement)

  3. Wrist-worn actigraphy (ActiGraph) to be worn while awake [(T0) baseline through (T3) 90 days post-intervention]

    Change in physical activity (Frequent physical activity indicates improvement)

  4. Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro [(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 Outcome Measures

  1. Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6 [(T0) baseline through (T3) 90 days post-intervention]

    Change in diabetes distress ( 0-6, lower scores indicates improvement)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 90 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Boston College Chestnut Hill Massachusetts United States 02647

Sponsors and Collaborators

  • Boston College
  • National Institute of Nursing Research (NINR)
  • National Institutes of Health (NIH)

Investigators

  • Principal Investigator: Cherlie Magny-Normilus, PhD, FNP-BC, Boston College

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Cherlie Magny-Normilus, Research Scholar, Boston College
ClinicalTrials.gov Identifier:
NCT04949568
Other Study ID Numbers:
  • 20.236.01
First Posted:
Jul 2, 2021
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by Cherlie Magny-Normilus, Research Scholar, Boston College
Immigrant Health
Diabetes Mellitus, Type 2
Metabolic Diseases
Self-Management Behaviors
Haitian Americans
Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Jul 8, 2022