Chronic Disease Self-management Program for Hypertension Control in Churches

NCT04437966 | Unknown DMC

• 1 other identifier: BLSCHP-2008
• Study Type: interventional
• Target: 384
• Locations: 1 country
• Sites: 1

Brief 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. 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. 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. 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.

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

• Systolic blood pressure

  We will measure systolic blood pressure before and 6 months after the interventions

  Six months

Secondary Outcomes (4)

• Mean weight change for intervention and control groups

  Six months

• Level of adherence to the Dietary Approaches to Stop Hypertension (DASH) Diet

  Six months

• Assessing physical activity levels using the Global Physical Activity Questionnaire (GPAQ)

  Six months

• Self-Efficacy for Managing Chronic Diseases 6-item Scale

  Six months

Study Arms (2)

Self-management Group

EXPERIMENTAL

The intervention consists of three levels - (1) chronic disease self-management workshops, (2) distribution of and teaching on the use of medication pill boxes and (3) use of social media (WhatsApp version 2.0) to encourage medication adherence. We combine the Stanford Chronic Disease Self-Management Curriculum, add medication adherence tools and social media use to develop a novel intervention aimed at better blood pressure control. The CDSMP focuses on enhancing skills through problem solving and brainstorming activities. In the workshop we discuss: blood pressure control, finding and affording healthy foods, label reading, physical activity, planning a healthy plate, making traditional foods healthy and portion control. Pill boxes will be distributed to all individuals in the intervention group. Post workshop, participants will be sent twice weekly reminders to use their high blood pressure medications via the social media tool WhatsApp. These will be sent for one month.

Behavioral: Enhanced Chronic Disease Self-management program

Usual care group

NO INTERVENTION

Controls will receive educational material at baseline and one didactic session (on importance of medication adherence to hypertension control) lasting 1 hour delivered by a health care professional.

Interventions

Enhanced Chronic Disease Self-management program BEHAVIORAL

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.

Self-management Group

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Resident in Barbados for the previous six months
• No plans to migrate over the ensuing one year.
• All persons with a previous diagnosis of hypertension or currently on anti- hypertensives AND the occurrence of two or more blood pressure readings above 140 mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment will be deemed eligible.
• Persons not known to have hypertension but who have two or more blood pressure readings above 140 mmHg (systolic) or 90mmHg (diastolic) on the day of recruitment are also eligible

You may not qualify if:

• Non-residents of Barbados
• Persons whose systolic blood pressure is below 140mmHg AND/OR diastolic blood pressure below 90mmHg
• Persons who are pregnant of planning to become pregnant over the following nine months
• Unwillingness/inability to comply with the study protocol
• Current participation in another study

Sponsors & Collaborators

• The University of The West Indies: lead
• Harvard School of Public Health (HSPH): collaborator

Study Sites (1)

George Alleyne Chronic Disease Research Centre

Bridgetown, BB15000, Barbados

RECRUITING

Related Publications (1)

• Sobers NP, Hambleton IR, Hassan S, Anderson SG, Brathwaite-Graham L, Lewis K, Ferguson TS. Assessing the effectiveness and implementation of a chronic disease self-management programme in faith-based organisations in Barbados: protocol for a cluster randomised parallel trial. BMJ Open. 2021 Oct 4;11(10):e050548. doi: 10.1136/bmjopen-2021-050548.

  PMID: 34607863 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Natasha P Sobers, PhD

  George Alleyne Chronic Disease Research Centre

  PRINCIPAL INVESTIGATOR

• Lisa Brathwaite-Graham, MPH

  George Alleyne Chronic Disease Research Centre

  STUDY DIRECTOR

Central Study Contacts

Natasha P Sobers, PhD

CONTACT

2464266416; natasha.sobers@cavehill.uwi.edu

Ian Hambleton, PhD

CONTACT

2464266416; ian.hambleton@cavehill.uwi.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Data collectors will be blinded to church randomization status until the end of the six-week recruitment period.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Epidemiology

Model Details: Twelve faith based organizations will be chosen from an organization known as New Testament Church of God Assemblies (a Pentecostal religion). Of the 12 organizations selected to participate in the study, six will be randomized to receive the intervention and six will receive usual care. the study statistician will randomly assign each church to either intervention or control groups based on a 1:1 ratio, using a pre-specified random number generator (Stata statistical software version 16). Using a 3-church block, we will assign 2 churches to intervention and 2 churches to control in each randomization block. Block randomization will be used to ensure balanced distribution of intervention and control churches.

Study Record Dates

• First Submitted: June 11, 2020
• First Posted: June 18, 2020
• Study Start: October 11, 2020
• Primary Completion: October 1, 2021
• Study Completion: December 1, 2021
• Last Updated: June 24, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data will become available two years after the study analysis is complete.
• Access Criteria: IPD will only be shared if the absolute number of participants is greater than 20. There will be grouping of variables (such as exact age) that may contribute to "potential identifiability" of participants. Researchers will be given the option of contact with PI to use original dataset for approved research purposes.

Locations

BA (1)