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HypertensionCONNECT-HTNNCT07461415

Coaching and Navigation by Community Health Workers (CHWs) Through Telehealth for High-risk Hypertension

A study testing CONNECT-HTN and Standard ED management in people with Hypertension, run by Weill Medical College of Cornell University at 5 sites in Pakistan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The investigators propose an intervention that leverages the success of Community Healthcare Workers (CHWs) and telehealth to connect patients with severe hypertension from Emergency Department (ED) to primary care resources and to coach them to adopt evidence-based, practical lifestyle solutions relevant to urban… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hypertension
What is being tested?
CONNECT-HTN and Standard ED management
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,620 participants
Where
5 sitesPakistan
Study dates
16 Mar 2026to Aug 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

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

  • Eligible patients
  • Must be over the age of 18 years
  • Have an ED triage SBP ≥ 180 and/or DBP ≥ 110, with a repeat similar reading ≥30 minutes after triage
  • May have received treatment for elevated BP, but must have no evidence of end-organ damage (defined as dialysis dependence, acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
  • Have a functional status of either fully active (independent in daily activities) or mildly restricted but ambulatory and able to work (washing, toileting, dressing, feeding, mobility).
  • May be admitted for deranged BP only with no complications, or may be stable for discharge per treating emergency physician
Show all 9Show fewer
  • Include referrals from the clinic to the ED with SBP/DBP values in the inclusion range
  • Can provide informed consent. Intervention is accessible to individuals of all literacy levels
  • Can receive phone calls and in-person visits. Smartphone ownership not required (intervention compatible with analog phones)

Who cannot join

  • Given that hypertension is defined and treated differently, we will exclude
  • pregnant patients
  • terminally ill patients, as well as
  • those requiring admission to the hospital due to severe complications (other than deranged BP).

Trial locations and contacts

5 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Junaid A Razzak, MD PhD FACEP contact

+1 4437229239

jur9123@med.cornell.edu

Sheza Hassan, MD MSc contact

+1 9296213558

shh4019@med.cornell.edu

5 sites in 1 country

Pakistan5 sites, 4 recruiting

  • Aga Khan University Hospital (AKUH)

    Karachi, Sindh

    Badar Afzal, MBBS

    Badar Afzal, MBBS

    Recruiting

  • Dow University Hospital, Ojha Campus

    Karachi, Sindh

    Withdrawn

  • Jinnah Postgraduate Medical Center (JPMC)

    Karachi

    Recruiting

  • Kharadar General Hospital (KGH)

    Karachi

    Recruiting

  • Sindh Institute of Emergency and Health Sciences (SIEHS)

    Karachi

    Taaban Khan, MBBS

    Recruiting

Other trials in Pakistan

About this study

Official title: CONNECT-HTN Trial - Coaching and Navigation by CHWs Through Telehealth for High-risk Hypertension

The investigators propose an intervention that leverages the success of Community Healthcare Workers (CHWs) and telehealth to connect patients with severe hypertension from Emergency Department (ED) to primary care resources and to coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. The investigators have proposed this intervention as "Coaching and Navigation by Community Health Workers (CHWs) through Telehealth for High-risk Hypertension: CONNECT-HTN intervention. The investigators hypothesize that participants receiving the CONNECT-HTN intervention will have a lower likelihood of experiencing a major cardiac event compared with those referred to clinic-based care.

Read the detailed description

This study is a randomized controlled trial evaluating whether telehealth-based coaching and navigation delivered by community health workers can improve cardiovascular outcomes among adults presenting to Emergency Departments (EDs) in Karachi with severe hypertension. Participants are randomly assigned either to receive a standard referral to primary care or to receive structured telephone-based navigation and behavioral coaching from trained community health workers.

The primary objective is to determine whether the CONNECT-HTN intervention reduces the rate of major adverse cardiovascular events (MACE) over the follow-up period. Secondary objectives include evaluating changes in blood pressure over time and examining patterns of follow-up in outpatient primary care. Outcome assessments are conducted by an independent team blinded to treatment assignment.

The study aims to provide evidence on the effectiveness of a scalable telehealth-supported community health worker model for improving long-term outcomes among patients with severe hypertension in low-resource urban settings.

Conditions
Hypertension
Being tested
CONNECT-HTN, Standard ED management
Keywords
Community Healthcare Workers, Hypertension, Telehealth, Low-middle-income country
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CONNECT-HTNBehavioural

    We propose a multimodal intervention that leverages the success of CHWs and telehealth to connect patients with severe hypertension to primary care resources and coach them to adopt evidence-based, practical lifestyle solutions relevant to urban living. We call the intervention Coaching and Navigation by CHW through Telehealth for High-risk Hypertension or CONNECT-HTN. CONNECT HTN will add to the evidential basis for implementing many of the WHO Best Buys for Non-Communicable Disease (NCD) prevention and control, and will be the first study powered to measure substantive mortality and mortality outcomes in LMICs.

  • Standard ED managementOther

    During the Emergency Department (ED) admission, the participants in the control group will be provided a blood pressure measurement device and training to calculate their blood pressure at home. Standard ED management will be provided to these patients, followed by either discharge or admission for the management of hypertension.

Study groups in NCT07461415
Study groupRoleWhat they receive
Referral armActive comparatorIn the referral arm, patients with hypertension will receive a digital BP monitor (an Omron device), a brief teaching session on its proper use, and an emergency medical services number for any medical concerns. A small outcomes team will visit their household within 3 months of their discharge from the Emergency Department (ED) to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.
Receives: Other: Standard ED management
T-CHW armExperimentalIn the T-CHW arm, patients with hypertension will receive a digital BP monitor (an Omron device) and a brief teaching session on its proper use. They will also be connected with a Community Healthcare Worker (CHW) via a telephone number. The CHW will call them to ask about their health and counsel them on diet and exercise to support good blood pressure control. The CHW will call them every month at a mutually convenient time for up to 36 months. A small outcomes team will visit their household within 3 months of their discharge from the ED to review their readings and ask a few more questions about their health. This outcome team will visit every 6 months for a total of five home visits to monitor their health.
Receives: Behavioral: CONNECT-HTN

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Rate of Major Adverse Cardiac Events (MACE)

    Major Adverse Cardiovascular Events (MACE) is a composite outcome including heart attack (myocardial infarction), stroke, heart failure, and cardiovascular death. The primary outcome will be assessed by comparing the cumulative incidence of MACE events between participants randomized to the CONNECT-HTN intervention arm and those randomized to referral to clinic-based care. MACE events will be identified through participant interviews, hospital record review, death certificates during the outcome collection team visit and verbal autopsy when required, and adjudicated using standardized criteria.

    Measured: Up to 36 months (during the outcome collection period)

Secondary outcomes (3)

  1. Blood Pressure (SBP/DBP) Over Time

    Change in systolic and diastolic blood pressure over time, measured during blinded home visits using standardized oscillometric assessment. At each visit, three blood pressure readings will be obtained five minutes apart and averaged. Longitudinal blood pressure trajectories will be compared between trial arms.

    Measured: Every 6 months during follow-up (up to 36 months)

  2. Outpatient Primary Care Follow-up

    Proportion of participants who attend at least one outpatient primary care visit for hypertension management during the study period, assessed via participant report and/or available medical records during the outcome collection team visit

    Measured: Up to 36 months

  3. Medication Adherence (MMAS-8 Score)

    Medication adherence will be assessed using the 8-item Morisky Medication Adherence Scale (MMAS-8), a validated self-report questionnaire commonly used in hypertension research. Scores range from 0 to 8, with higher scores indicating greater adherence. Adherence will be measured during blinded home visits and compared between study arms over time during the outcome collection team visit.

    Measured: Every 6 months during the 36-month follow-up period.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Mar 2026
  2. Study start16 Mar 2026
  3. Primary completionAug 2029 (estimated)
  4. Study completionAug 2029 (estimated)

Resources

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
Randomised
Intervention model
Parallel groups
Model description
Stratified and blocked randomization will be used for individuals meeting enrollment criteria. The randomization will be stratified by gender, and blocked randomization (with varying block sizes) will be used to allocate patients in a 1:1 ratio to either the T-CHW or the referral arm
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
3,620 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07461415
Sponsor's protocol ID
25-10029420
Other IDs
R33HL172268
Acronym
CONNECT-HTN
Status last verified
Sep 2026
First submitted
27 Feb 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Anonymized Individual Patient Data (IPD) that underlies results will be submitted in a report format to NIH and published in well-reputed journals.

Publications

  • NCD Risk Factor Collaboration (NCD-RisC). Worldwide trends in blood pressure from 1975 to 2015: a pooled analysis of 1479 population-based measurement studies with 19.1 million participants. Lancet. 2017 Jan 7;389(10064):37-55. doi: 10.1016/S0140-6736(16)31919-5. Epub 2016 Nov 16.

    PubMed 27863813

  • Olsen MH, Angell SY, Asma S, Boutouyrie P, Burger D, Chirinos JA, Damasceno A, Delles C, Gimenez-Roqueplo AP, Hering D, Lopez-Jaramillo P, Martinez F, Perkovic V, Rietzschel ER, Schillaci G, Schutte AE, Scuteri A, Sharman JE, Wachtell K, Wang JG. A call to action and a lifecourse strategy to address the global burden of raised blood pressure on current and future generations: the Lancet Commission on hypertension. Lancet. 2016 Nov 26;388(10060):2665-2712. doi: 10.1016/S0140-6736(16)31134-5. Epub 2016 Sep 23. No abstract available.

    PubMed 27671667

  • GBD 2019 Diseases and Injuries Collaborators. Global burden of 369 diseases and injuries in 204 countries and territories, 1990-2019: a systematic analysis for the Global Burden of Disease Study 2019. Lancet. 2020 Oct 17;396(10258):1204-1222. doi: 10.1016/S0140-6736(20)30925-9.

    PubMed 33069326

  • Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020 Apr;16(4):223-237. doi: 10.1038/s41581-019-0244-2. Epub 2020 Feb 5.

    PubMed 32024986

  • Knoery CR, Heaton J, Polson R, Bond R, Iftikhar A, Rjoob K, McGilligan V, Peace A, Leslie SJ. Systematic Review of Clinical Decision Support Systems for Prehospital Acute Coronary Syndrome Identification. Crit Pathw Cardiol. 2020 Sep;19(3):119-125. doi: 10.1097/HPC.0000000000000217.

    PubMed 32209826

  • Jafar TH, Gandhi M, de Silva HA, Jehan I, Naheed A, Finkelstein EA, Turner EL, Morisky D, Kasturiratne A, Khan AH, Clemens JD, Ebrahim S, Assam PN, Feng L; COBRA-BPS Study Group. A Community-Based Intervention for Managing Hypertension in Rural South Asia. N Engl J Med. 2020 Feb 20;382(8):717-726. doi: 10.1056/NEJMoa1911965.

    PubMed 32074419

  • Schwalm JD, McCready T, Lopez-Jaramillo P, Yusoff K, Attaran A, Lamelas P, Camacho PA, Majid F, Bangdiwala SI, Thabane L, Islam S, McKee M, Yusuf S. A community-based comprehensive intervention to reduce cardiovascular risk in hypertension (HOPE 4): a cluster-randomised controlled trial. Lancet. 2019 Oct 5;394(10205):1231-1242. doi: 10.1016/S0140-6736(19)31949-X. Epub 2019 Sep 2.

    PubMed 31488369

  • Peiris D, Praveen D, Mogulluru K, Ameer MA, Raghu A, Li Q, Heritier S, MacMahon S, Prabhakaran D, Clifford GD, Joshi R, Maulik PK, Jan S, Tarassenko L, Patel A. SMARThealth India: A stepped-wedge, cluster randomised controlled trial of a community health worker managed mobile health intervention for people assessed at high cardiovascular disease risk in rural India. PLoS One. 2019 Mar 26;14(3):e0213708. doi: 10.1371/journal.pone.0213708. eCollection 2019.

    PubMed 30913216

  • Neupane D, McLachlan CS, Mishra SR, Olsen MH, Perry HB, Karki A, Kallestrup P. Effectiveness of a lifestyle intervention led by female community health volunteers versus usual care in blood pressure reduction (COBIN): an open-label, cluster-randomised trial. Lancet Glob Health. 2018 Jan;6(1):e66-e73. doi: 10.1016/S2214-109X(17)30411-4.

    PubMed 29241617

  • He J, Irazola V, Mills KT, Poggio R, Beratarrechea A, Dolan J, Chen CS, Gibbons L, Krousel-Wood M, Bazzano LA, Nejamis A, Gulayin P, Santero M, Augustovski F, Chen J, Rubinstein A; HCPIA Investigators. Effect of a Community Health Worker-Led Multicomponent Intervention on Blood Pressure Control in Low-Income Patients in Argentina: A Randomized Clinical Trial. JAMA. 2017 Sep 19;318(11):1016-1025. doi: 10.1001/jama.2017.11358.

    PubMed 28975305

  • Bosworth HB, Olsen MK, McCant F, Harrelson M, Gentry P, Rose C, Goldstein MK, Hoffman BB, Powers B, Oddone EZ. Hypertension Intervention Nurse Telemedicine Study (HINTS): testing a multifactorial tailored behavioral/educational and a medication management intervention for blood pressure control. Am Heart J. 2007 Jun;153(6):918-24. doi: 10.1016/j.ahj.2007.03.004.

    PubMed 17540191

  • Mishra SR, Lygidakis C, Neupane D, Gyawali B, Uwizihiwe JP, Virani SS, Kallestrup P, Miranda JJ. Combating non-communicable diseases: potentials and challenges for community health workers in a digital age, a narrative review of the literature. Health Policy Plan. 2019 Feb 1;34(1):55-66. doi: 10.1093/heapol/czy099.

    PubMed 30668690

  • Morcillo Serra C, Aroca Tanarro A, Cummings CM, Jimenez Fuertes A, Tomas Martinez JF. Impact on the reduction of CO2 emissions due to the use of telemedicine. Sci Rep. 2022 Jul 22;12(1):12507. doi: 10.1038/s41598-022-16864-2.

    PubMed 35869274

  • Wu S, Li M, Lu J, Tang X, Wang G, Zheng R, Niu J, Chen L, Huo Y, Xu M, Wang T, Zhao Z, Wang S, Lin H, Qin G, Yan L, Wan Q, Chen L, Shi L, Hu R, Su Q, Yu X, Qin Y, Chen G, Gao Z, Shen F, Luo Z, Chen Y, Zhang Y, Liu C, Wang Y, Wu S, Yang T, Li Q, Mu Y, Zhao J, Ning G, Bi Y, Wang W, Xu Y; China Cardiometabolic Disease and Cancer Cohort (4C) Study Groupdagger. Blood Pressure Levels, Cardiovascular Events, and Renal Outcomes in Chronic Kidney Disease Without Antihypertensive Therapy: A Nationwide Population-Based Cohort Study. Hypertension. 2023 Mar;80(3):640-649. doi: 10.1161/HYPERTENSIONAHA.122.19902. Epub 2023 Jan 5.

    PubMed 36601917

  • Kotruchin P, Mitsungnern T, Ruangsaisong R, Imoun S, Pongchaiyakul C. Hypertensive Urgency Treatment and Outcomes in a Northeast Thai Population: The Results from the Hypertension Registry Program. High Blood Press Cardiovasc Prev. 2018 Sep;25(3):309-315. doi: 10.1007/s40292-018-0272-1. Epub 2018 Jul 26.

    PubMed 30051205

Questions about this trial

What is this clinical trial studying?

A study testing CONNECT-HTN and Standard ED management in people with Hypertension, run by Weill Medical College of Cornell University at 5 sites in Pakistan.

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 9 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Junaid A Razzak, MD PhD FACEP (+1 4437229239, jur9123@med.cornell.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Major Adverse Cardiac Events (MACE) (time frame: Up to 36 months (during the outcome collection period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07461415, which also lists 18 linked publications.

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 17 Sep 2026.

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