Clinical trial NCT04949568: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Patient Engagement
Patient Education
Keywords: Immigrant Health
Diabetes Mellitus, Type 2
Metabolic Diseases
Self-Management Behaviors
Haitian Americans
Lead sponsor: New York University
Sponsor class: OTHER
First posted: 2021-07-02
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Behavioral: Diabetes Self-management behaviors
Primary purpose: SUPPORTIVE_CARE

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 40 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).

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

Primary outcomes:
measure: Summary of Diabetes of Self-Care Activities Scale (11- item)
timeFrame: (T0) baseline through (T3) 90 days post-intervention
measure: Stanford Diabetes Self-Efficacy Scale (8- item)
timeFrame: (T0) baseline through (T3) 90 days post-intervention
measure: Wrist-worn actigraphy (ActiGraph) to be worn while awake
timeFrame: (T0) baseline through (T3) 90 days post-intervention
measure: Glucose Variability data from continuous glucose monitor (CGM) will be downloaded directly from participants provided (blinded) FreeStyle Libre Pro
timeFrame: (T0) baseline through (T3) 90 days post-intervention
Secondary outcomes:
measure: Diabetes Distress Scale (DDS) (17-item), using Numerical Rating Scale: 0-6
timeFrame: (T0) baseline through (T3) 90 days post-intervention
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University
state: New York
Study officials:
affiliation: New York University
name: Cherlie Magny-Normilus, PhD, FNP-BC, FAAN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Magny-Normilus C, Whittemore R, Wexler DJ, Schnipper JL, Nunez-Smith M, Fu MR. Barriers to Type 2 Diabetes Management Among Older Adult Haitian Immigrants. Sci Diabetes Self Manag Care. 2021 Oct;47(5):382-390. doi: 10.1177/26350106211040435.