HypertensionCB-HEARTSNCT05954884
Community-based HEARTS Intervention (Pilot)
A study testing Telemedicine-based WHO HEARTS package in people with Hypertension, run by National Heart Foundation of Bangladesh.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Telemedicine-based WHO HEARTS package
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 31 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
- Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
Trial locations and contacts
No sites are listed yet.
About this study
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
- Being tested
- Telemedicine-based WHO HEARTS package
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telemedicine-based WHO HEARTS packageOther
Interventions in this study will include-
- Community- and team-based model of hypertension care delivery
- Opportunistic hypertension screening at Community Clinic (CC) by Community Health Care Provider (CHCP)
- 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
- Use of Simple App to document BP readings and medications/dosage and to monitor hypertension care delivery at the CC through utilities including dashboards
- Establishment of telemedicine service between CC and Upazila Health Complex (UHC)
- Community-based, multi-month prescription refills from CC
- Training of clinic and research staff on BP measurement following standard techniques
- Site monitoring and mentorship to ensure screening and patient enrollment/registration
- Use of text messages to promote follow-up visits and medication adherence
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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). Receives: Other: Telemedicine-based WHO HEARTS package |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment proportion
The proportion of eligible individuals with raised BP identified at the Community Clinic (CC) who were enrolled, defined as those started on meds within 6 months of diagnosis
Measured: 6 months from enrollment
Short-term, intermediate, and long-term retention in care
The proportion of enrolled individuals with raised BP who had a follow-up visit within 3 months of enrollment (short-term retention in care), between 6 and 12 months (intermediate retention in care), and between 12 and 18 months (long-term retention in care)
Measured: 3 months from enrollment for short-term retention in care, 6 to 12 months for intermediate retention in care, and 12 to 18 months for long-term retention in care
Secondary outcomes (1)
Blood pressure control
The proportion of those enrolled at the Community Clinic with BP controlled (<140/90 mmHg) at 3, 6, 12, and 18 months (denominator includes patients who do not return for follow up BP measurement)
Measured: 3, 6, 12, and 18 months from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Foundation of Bangladesh
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Foundation Hospital and Research Institute, Johns Hopkins University, Directorate General of Health Services, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Sohel R Choudhury, PhD, Principal investigator, National Heart Foundation Hospital and Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05954884
- Sponsor's protocol ID
- BMRC/NREC/2022-2025/102
- Acronym
- CB-HEARTS
- Status last verified
- Jul 2023
- First submitted
- 13 Jul 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Community-based HEARTS Intervention (Pilot)
- ClinicalTrials.gov ID
- NCT05954884
- Acronym / sponsor ID
- CB-HEARTS / BMRC/NREC/2022-2025/102
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- National Heart Foundation of BangladeshUniversity, hospital or other
- Collaborators
- National Heart Foundation Hospital and Research Institute, Johns Hopkins University, Directorate General of Health Services, Bangladesh
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Telemedicine-based WHO HEARTS packageThis 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (3 listed)
- 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
- Patients who otherwise meet inclusion criteria but decline to participate in the hypertension program evaluation or do not provide written informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telemedicine-based WHO HEARTS packageInterventions 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 | Other | Intervention |
Primary outcome
Enrollment proportion
Time frame: 6 months from enrollment
The proportion of eligible individuals with raised BP identified at the Community Clinic (CC) who were enrolled, defined as those started on meds within 6 months of diagnosis
Short-term, intermediate, and long-term retention in care
Time frame: 3 months from enrollment for short-term retention in care, 6 to 12 months for intermediate retention in care, and 12 to 18 months for long-term retention in care
The proportion of enrolled individuals with raised BP who had a follow-up visit within 3 months of enrollment (short-term retention in care), between 6 and 12 months (intermediate retention in care), and between 12 and 18 months (long-term retention in care)
1 secondary outcome
Blood pressure control
Time frame: 3, 6, 12, and 18 months from enrollment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sohel R Choudhury, PhD principal investigator
National Heart Foundation Hospital and Research Institute
Questions about this trial
What is this clinical trial studying?
A study testing Telemedicine-based WHO HEARTS package in people with Hypertension, run by National Heart Foundation of Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sohel R Choudhury, PhD (+880258054708 ext. 258, choudhurys@nhf.org.bd), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment proportion (time frame: 6 months from enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.