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

Official title

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

Overview

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.

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.

Interventions

• Behavioral CONNECT-HTN
  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) preve
• Other Standard ED management
  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.

Primary outcome measures

• Rate of Major Adverse Cardiac Events (MACE) [Time frame: Up to 36 months (during the outcome collection period)]

Secondary outcome measures (3)

• Blood Pressure (SBP/DBP) Over Time [Time frame: Every 6 months during follow-up (up to 36 months)]
• Outpatient Primary Care Follow-up [Time frame: Up to 36 months]
• Medication Adherence (MMAS-8 Score) [Time frame: Every 6 months during the 36-month follow-up period.]

Eligibility criteria

Inclusion criteria

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 (acute stroke, acute coronary syndrome, acute kidney injury, or papilledema)
• May be admitted for deranged BP only with no complications, or may be stable for discharge per treating emergency physician
• 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)

Exclusion criteria

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Double blind

Primary purpose

Health services research

Study locations

Pakistan · 4 centers

• Aga Khan University Hospital (AKUH) — Karachi
• Dow University of Health Sciences, Ojha Campus (DUHS) — Karachi
• Jinnah Postgraduate Medical Center (JPMC) — Karachi
• Sindh Institute of Emergency and Health Sciences (SIEHS) — Karachi

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. PMID 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 PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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):e02 PMID 30913216

Identifiers

NCT: NCT07461415 · 25-10029420 · R33HL172268

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗