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Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan

StatusActive, Not Recruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 3 months later Aug 31, 2027 → Dec 1, 2027
Primary endpoint reworded 1 of 1 changed
See other at-risk trials from Aga Khan University

Record History

  1. Minor Re-verified, no change to tracked fieldsv6
  2. Notable Primary endpoint(s) modified Primary completion pushed from Aug 31, 2027 to Dec 1, 2027 · Completion pushed from Dec 2027 to Mar 31, 2028 · Enrollment target: 3476 to 3459 · 1 morev5 Show 4 more changesShow less
    • Primary completion pushed from Aug 31, 2027 to Dec 1, 2027
    • Completion pushed from Dec 2027 to Mar 31, 2028
    • Enrollment target: 3476 to 3459
    • Publications: 23 to 1

    See this version in full on ClinicalTrials.gov ↗

  3. Minor Re-verified, no change to tracked fieldsv4
  4. Minor Trial status: Recruiting to Active, Not Recruiting Enrollment target: estimated 3000 to confirmed 3476 · Primary completion date: Jul 31, 2027 to Aug 31, 2027 · Eligibility criteria expanded, about 7 words · 1 morev3 Show 4 more changesShow less
    • Enrollment target: estimated 3000 to confirmed 3476
    • Primary completion date: Jul 31, 2027 to Aug 31, 2027
    • Eligibility criteria expanded, about 7 words
    • Site details revised

    See this version in full on ClinicalTrials.gov ↗

  5. Notable Lead sponsor: Zainab Samad to Aga Khan University Trial status: Not Yet Recruiting to Recruiting · Site details revised · Study title shortened, about 6 words · 1 morev2 Show 4 more changesShow less
    • Trial status: Not Yet Recruiting to Recruiting
    • Site details revised
    • Study title shortened, about 6 words
    • Collaborators expanded, about 3 words

    See this version in full on ClinicalTrials.gov ↗

  6. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
1,795 trials monitored
See 85 trials at risk
This is a research about cardiovascular disease risk reduction: a comprehensive package for the reduction of risk in Sindh, Pakistan. The research is being conducted by the Aga Khan University and is funded by the National Institute of Health and Care Research UK. Hypertension is a major public health concern globally. It is a significant risk for cardiovascular disease (CVD) and premature death. In Pakistan, the prevalence of hypertension, including those on medication, is high. However, there are also high rates of undertreatment and underdiagnosis of hypertension in Pakistan. Addressing the prevention and control of CVD requires a multi-faceted approach that targets diverse populations across different settings. In some populations, we have interventions that have been proven effective but have not been implemented for example in rural communities. In Pakistan, prior community-based trial regarding multi-component hypertension intervention has proven to be effective in reducing blood pressure. However, the findings of this work have not translated to change in practice on the ground suggesting the need for implementation research to examine the best ways to implement this intervention in the real world. Hence, in this study researchers aim to assess the impact of this evidence-based intervention when implemented at scale in rural communities. Participants will be asked to participate in a research study designed to improve their blood pressure control. This study enrols participants aged 35 years and above. As part of this study, they will undergo: * blood pressure measurements at regular intervals by lady health workers * home health education sessions conducted by lady health workers * participants may be referred to a nearby health facility/qualified medical practitioners for management of high blood pressure * baseline survey at the start of the study having questions about participants' medical history, risk factors for cardiovascular disease and high blood pressure and bodily measurements including weight, height and waist circumference * follow-up surveys every 6 months for 2.5 years. The survey questions will comprise of medical history, risk factors for cardiovascular disease and high blood pressure; and bodily measurements including weight, height and waist circumference * blood and urine samples for testing at baseline survey and during endline survey POSSIBLE RISKS OR DISCOMFORT There are no risks involved as a result of participants' participation in this study except for their time. Since they will be followed up for 2.5 years, any new information developed during the study that may affect their willingness to continue participation will be communicated to them. Participants may feel a little discomfort at the site of the needle prick when drawing a blood sample. POSSIBLE BENEFITS Participants will be able to know about their risk of high blood pressure and cardiovascular disease. They'll be referred to a qualified medical practitioner for the management of your high blood pressure. Also, the results of their blood and urine tests will be shared with participants that will help them know about their health. The main contact for this research study is the principal investigator Dr Zainab Samad (02134864660).
Trial Details
NCT Number NCT06726057
Lead Sponsor Aga Khan University
Collaborators: University of York
Conditions Hypertension
Enrollment 3,459 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov