Chronic Disease Self-management Program for Hypertension Control in Churches
NCT04437966 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384
Last updated 2021-06-24
Summary
In Barbados, levels of hypertension are high (40.7%) and cause of a high proportion of deaths due to cardiovascular diseases. In this study, the Stanford University-led Chronic Disease Self-Management Program (CDSMP) will be modified to form one of the basic components of a three-pronged intervention to improve blood pressure control.
Our overall goal is to evaluate the effectiveness of a hypertension self-management program in community-based settings. With the advent of the Coronavirus disease 2019 (COVID-19) we recognize that it may be necessary to adapt the programme to accommodate virtual delivery.
Our specific aims are to:
1. Adapt the Stanford (CDSMP) to ensure cultural appropriateness to Barbados. In view of the need to adhere to physical distance guidelines in the era of COVID-19 disease, modifications will be made to enhance virtual delivery while maintaining programme fidelity. We will engage stakeholders in performing modifications related to content, context and mode of delivery of the CDSMP program with the goal of ensuring cultural appropriateness.
2. Determine the clinical effectiveness of CDSMP combined with medication enhancement tools. We will conduct a cluster randomized trial in twelve faith-based organizations(FBOs) in Barbados. We are primarily interested in studying the changes in systolic blood pressure. Secondarily, we will also assess change in weight, medication adherence, dietary behavior and physical activity.
3. Understand the barriers and facilitators to implementation and sustainability of CDSMP plus self-monitoring tools in faith-based organizations. We will assess cost and sustainability of the intervention and qualitatively assess factors associated with barriers and facilitators of implementation in FBOs in Barbados.
Impact and novelty: We aim to increase the proportion of patients with controlled hypertension leading to reduced illness and deaths from strokes and heart attacks in particular. Few studies have looked at a blended approach to CDSMP delivery and these will become more necessary in the era of COVID-19. Findings on the factors impacting implementation will be transferable to small island developing states and other predominantly black populations.
Conditions
Interventions
- BEHAVIORAL
-
Enhanced Chronic Disease Self-management program
CDSMP workshops will last for approximately 2.5 hours and occur weekly for six weeks. Sessions will focus on appropriate diet for persons with hypertension and to facilitate weight loss; managing medications, adherence to medical clinic appointments; physical activity and stress management. Participants make weekly action plans, share experiences, and help each other solve problems they encounter in creating and carrying out their self-management program. Participants will also be given pill boxes and will be prompted by social media messages to make and keep clinic appointments as well as maintain a healthy lifestyle.
Sponsors & Collaborators
-
Harvard School of Public Health (HSPH)
collaborator OTHER -
The University of The West Indies
lead OTHER
Principal Investigators
-
Natasha P Sobers, PhD · George Alleyne Chronic Disease Research Centre
-
Lisa Brathwaite-Graham, MPH · George Alleyne Chronic Disease Research Centre
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 35 Years
- Max Age
- 70 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-11
- Primary Completion
- 2021-10-31
- Completion
- 2021-12-31
Countries
- Barbados
Study Locations
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