FCHV-HTN Implementation Trial in Nepal

Study acronym: CHPC
StatusActive, Not Recruiting
PhaseNot applicable
Started

Free. We email you which fields changed when ClinicalTrials.gov updates this record.

Track this trial
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Enrollment closed, study ongoing Show 5 more changesShow less
    • Secondary endpoints: details revised at 2 of 12 entries
    • Study description expanded, about 9 words
    • Site details revised
    • Publications: details revised at 1 of 1 entry
    • Eligibility criteria expanded, about 2 words
  2. Study completion date: Aug 31, 2028 to Dec 31, 2027v12
  3. Re-verified, no change to tracked fieldsv11
  4. Study description revisedv10
  5. Study title revisedv9
Show 7 earlier versionsHide 7 earlier versions
  1. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Nov 15, 2024 to Dec 2, 2024
    • Site details revised
    v8
  2. Start date: Sep 30, 2024 to Nov 15, 2024v7
  3. Primary endpoints: 5 to 4v6 Show 7 more changesShow less
    • Trial status: Recruiting to Not Yet Recruiting
    • Primary completion date: Dec 2027 to Dec 31, 2027
    • Study completion date: Dec 2027 to Aug 31, 2028
    • Start date: Sep 2024 to Sep 30, 2024
    • Secondary endpoints: 2 to 12
    • Study description shortened, about 740 words
    • Site details revised
  4. Start date: Jul 2024 to Sep 2024v5
  5. Start date: Apr 2024 to Jul 2024
    • Study description revised
    v4
  6. Enrollment target: 2432 to 3572
    • Study description expanded, about 4 words
    v3
  7. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jan 2024 to Apr 2024
    • Study completion date: Aug 2028 to Dec 2027
    • Site details revised
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
Yale University
490 trials monitored
See 31 trials at risk
Hypertension
1,933 trials monitored
See 101 trials at risk
The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are: 1\. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels? 2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial. 3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy? Participants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.
Trial Details
NCT Number NCT06081010
Lead Sponsor Yale University
Collaborators: Dhulikhel Hospital, Institute for Implementation Science and Health, National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Hypertension
Related terms Hypertension
Enrollment 3,572 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov