Chronic Disease Self-management Program for Hypertension Control in Churches

NCT04437966 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 384

Last updated 2021-06-24

No results posted yet for this study

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04437966 on ClinicalTrials.gov