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

Primary Purpose

Diabetes Mellitus, Type 2, Patient Engagement, Patient Education

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diabetes Self-Management Behaviors
Sponsored by
Boston College
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • Boston College

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Diabetes Self-Management Behaviors

Usual Type 2 Diabetes Care

Arm 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.

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.

Outcomes

Primary Outcome Measures

Summary of Diabetes of Self-Care Activities Scale (11- item)
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Stanford Diabetes Self-Efficacy Scale (8- item)
Change in general self-efficacy 1-10, higher scores indicate improvement)
Wrist-worn actigraphy (ActiGraph) to be worn while awake
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 in range and glucose variability (More time in range and less glucose variability indicates improvement)

Secondary Outcome Measures

Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
Change in diabetes distress ( 0-6, lower scores indicates improvement)

Full Information

First Posted
June 25, 2021
Last Updated
July 25, 2023
Sponsor
Boston College
Collaborators
National Institute of Nursing Research (NINR), National Institutes of Health (NIH)
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1. Study Identification

Unique Protocol Identification Number
NCT04949568
Brief Title
Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes
Official Title
Self-Management and Glycemic Control in Adult Haitian Immigrants With Type 2 Diabetes: A Pilot Randomized Study
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
August 1, 2023 (Anticipated)
Primary Completion Date
January 31, 2024 (Anticipated)
Study Completion Date
July 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Boston College
Collaborators
National Institute of Nursing Research (NINR), National Institutes of Health (NIH)

4. Oversight

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
Data Monitoring Committee
No

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Patient Engagement, Patient Education
Keywords
Immigrant Health, Diabetes Mellitus, Type 2, Metabolic Diseases, Self-Management Behaviors, Haitian Americans

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Behavioral: Diabetes Self-management behaviors
Masking
Participant
Masking Description
Both conditions will receive standard care. We will use sequentially numbered opaque sealed envelopes to conceal the allocation determination
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Diabetes Self-Management Behaviors
Arm Type
Experimental
Arm 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.
Arm Title
Usual Type 2 Diabetes Care
Arm Type
No Intervention
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Diabetes Self-Management Behaviors
Intervention Description
The intervention is to be delivered by a diabetes educator.
Primary Outcome Measure Information:
Title
Summary of Diabetes of Self-Care Activities Scale (11- item)
Description
Change in diabetes self-management behaviors (0-7, higher scores indicate improvement)
Time Frame
(T0) baseline through (T3) 90 days post-intervention
Title
Stanford Diabetes Self-Efficacy Scale (8- item)
Description
Change in general self-efficacy 1-10, higher scores indicate improvement)
Time Frame
(T0) baseline through (T3) 90 days post-intervention
Title
Wrist-worn actigraphy (ActiGraph) to be worn while awake
Description
Change in physical activity (Frequent physical activity indicates improvement)
Time Frame
(T0) baseline through (T3) 90 days post-intervention
Title
Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
Description
Time in range and glucose variability (More time in range and less glucose variability indicates improvement)
Time Frame
(T0) baseline through (T3) 90 days post-intervention
Secondary Outcome Measure Information:
Title
Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
Description
Change in diabetes distress ( 0-6, lower scores indicates improvement)
Time Frame
(T0) baseline through (T3) 90 days post-intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cherlie Magny-Normilus, PhD, FNP-BC
Phone
617-552-8814
Email
cherlie.magny-normilus@bc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cherlie Magny-Normilus, PhD, FNP-BC
Organizational Affiliation
Boston College
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston College
City
Chestnut Hill
State/Province
Massachusetts
ZIP/Postal Code
02647
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cherlie Magny-Normilus, PhD
Phone
617-552-1184
Email
cherlie.magny-normilus@bc.edu
First Name & Middle Initial & Last Name & Degree
Jason Bowman, MS
Phone
617-552-8814

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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