Community-based HEARTS Intervention (Pilot)

NCT ID: NCT05954884

Last Updated: 2023-07-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-03-31

Brief Summary

The goal of this pilot study is to assess the feasibility of health system change intervention with a focus on recruitment of patients with hypertension, initiation of antihypertensive medication, and retention of patients in care at the Community Clinics (CC) with a goal of finalizing the key features of a team- and community-based intervention in rural Bangladesh.

Patients with uncomplicated hypertension will be enrolled, their medical treatment will be provided from CC by a Community Health Care Provider (CHCP) according to the telemedicine-based instruction of Medical Officer from Upazila Health Complex (UHC) with provision of referral to UHC for an in-person evaluation. Participants will be followed up periodically and their medicine will be refilled accordingly.

Conditions

Hypertension

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention

This is a single-arm pilot study and all participants will receive the intervention. Participants will be diagnosed and treated for hypertension at Community Clinic (CC) by a Community Health Care Provider (CHCP) under telemedicine supervision from a Medical Officer at the Upazila Health Complex (UHC).

Group Type: EXPERIMENTAL

Telemedicine-based WHO HEARTS package

Intervention Type: OTHER

Interventions in this study will include-

1. Community- and team-based model of hypertension care delivery

2. Opportunistic hypertension screening at Community Clinic (CC) by Community Health Care Provider (CHCP)

3. Use of a hypertension treatment protocol with amlodipine and losartan and standardized approach to measuring and monitoring BP, retaining participants in care, and promoting adherence

4. Use of Simple App to document BP readings and medications/dosage and to monitor hypertension care delivery at the CC through utilities including dashboards

5. Establishment of telemedicine service between CC and Upazila Health Complex (UHC)

6. Community-based, multi-month prescription refills from CC

7. Training of clinic and research staff on BP measurement following standard techniques

8. Site monitoring and mentorship to ensure screening and patient enrollment/registration

9. Use of text messages to promote follow-up visits and medication adherence

Interventions

Telemedicine-based WHO HEARTS package

Interventions in this study will include-

1. Community- and team-based model of hypertension care delivery

2. Opportunistic hypertension screening at Community Clinic (CC) by Community Health Care Provider (CHCP)

3. Use of a hypertension treatment protocol with amlodipine and losartan and standardized approach to measuring and monitoring BP, retaining participants in care, and promoting adherence

4. Use of Simple App to document BP readings and medications/dosage and to monitor hypertension care delivery at the CC through utilities including dashboards

5. Establishment of telemedicine service between CC and Upazila Health Complex (UHC)

6. Community-based, multi-month prescription refills from CC

7. Training of clinic and research staff on BP measurement following standard techniques

8. Site monitoring and mentorship to ensure screening and patient enrollment/registration

9. Use of text messages to promote follow-up visits and medication adherence

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients residing in the catchment area of the selected 4 Community Clinics under selected 2 Upazila Health Complexes (UHCs)
• Aged 18 years and older
• Raised BP during screening [Systolic BP ≥140 mmHg and/or diastolic BP ≥90 mmHg (based on an average of minimum two measurements)]
• Not currently taking antihypertensive medications
• Eligible for the HEARTS technical package, defined as not being treated for an acute illness or medical emergency and not having a terminal illness

Exclusion Criteria

• Patients with cardiovascular diseases, chronic kidney diseases (as evident by previous laboratory report of serum creatinine or urinary protein more than ++ on dipstick test prior to the enrollment), diabetes, or BP >180/110 mmHg (based on the mean of last two BP measurements) at screening or after 14 days of recommended lifestyle modification will be excluded and referred directly to UHC for further management
• Pregnancy or intent to become pregnant

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart Foundation Hospital and Research Institute

UNKNOWN

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: collaborator

Non-communicable Disease Control Programme, Directorate General of Health Services, Bangladesh

UNKNOWN

Sponsor Role: collaborator

Community Based Health Care, Directorate General of Health Services, Bangladesh

UNKNOWN

Sponsor Role: collaborator

National Heart Foundation of Bangladesh

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sohel R Choudhury, PhD

Role: PRINCIPAL_INVESTIGATOR

National Heart Foundation Hospital and Research Institute

Central Contacts

Sohel R Choudhury, PhD

Role: CONTACT

choudhurys@nhf.org.bd

+880258054708 ext. 258

Other Identifiers

BMRC/NREC/2022-2025/102

Identifier Type: -

Identifier Source: org_study_id