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| Name | Class |
|---|---|
| University of York | OTHER |
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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:
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 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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multicomponent hypertension intervention | Active Comparator | The multicomponent hypertension intervention arm (control arm) will receive the proven multicomponent hypertension intervention (MCHI) comprising four components. |
|
| Implementation strategies in conjunction with multicomponent hypertension intervention | Experimental | Implementation strategies in conjunction with multicomponent hypertension intervention arm (Intervention arm) will receive implementation strategies in conjunction with multi-component hypertension intervention (MCHI) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Imlementation strategies in conjunction with multicomponent hypertension intervention | Behavioral | In this study, the researchers will develop and test strategies for the implementation and scale-up of a proven multicomponent hypertension intervention (MCHI) programme in Pakistan. Implementation strategies will be devised through an engagement process and will involve the use of implementation frameworks including the Consolidated Framework for Implementation Research (CFIR) to identify barriers and facilitators to the implementation of MCHI& Expert Recommendations for Implementation Change (ERIC) to identify a set of implementation strategies addressing each barrier. Input for the development of strategies will be sought from the community, public health sector managers, general practitioners and community health workers. The implementation strategies will be used to randomise study clusters while MCHI will be implemented in both intervention and control arms. |
| Measure | Description | Time Frame |
|---|---|---|
| BP-lowering medications per participant | After estimating the proportional change in the number between the baseline and the 24-month follow-up, the mean difference between both the study arms will be estimated. A mean difference of 0.1 would be considered clinically significant. | From enrollment to the end of Intervention at 24 months |
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| Measure | Description | Time Frame |
|---|---|---|
| Implementation outcomes [as per RE-AIM framework domain of Adoption ] | The proportion of LHWs from 30 study clusters conducting HHE sessions, monitoring blood pressure and doing referrals of hypertensive patients to health facilities during the first 12 months Data source: HHE and referral checklists by LHWs, Baseline/follow-up survey | From enrollment to the first 12 months of Intervention |
Inclusion Criteria:
Age ≥35 years
Residents of the selected clusters
Have hypertension defined as either:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aga Khan University | Karachi | Sindh | 74800 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31473029 | Background | Smith JD, Hasan M. Quantitative approaches for the evaluation of implementation research studies. Psychiatry Res. 2020 Jan;283:112521. doi: 10.1016/j.psychres.2019.112521. Epub 2019 Aug 17. | |
| 33513161 | Background | Riaz M, Shah G, Asif M, Shah A, Adhikari K, Abu-Shaheen A. Factors associated with hypertension in Pakistan: A systematic review and meta-analysis. PLoS One. 2021 Jan 29;16(1):e0246085. doi: 10.1371/journal.pone.0246085. eCollection 2021. |
| Label | URL |
|---|---|
| Provisional summary results of 6th population and housing census-2017. Matiari district | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: 5. CVD Study Protocol V5 08112025 CT 1.4 | Nov 8, 2025 | Jan 8, 2026 | Prot_SAP_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.2 | Apr 27, 2025 | Jul 31, 2025 | Prot_SAP_001.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.1 | Oct 20, 2024 | Jul 31, 2025 | Prot_SAP_002.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: CVD Study Protocol V1.3 | Aug 28, 2025 | Oct 16, 2025 | Prot_SAP_003.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan: 6. CVD Study Protocol V6 27012026 | Jan 27, 2026 | Jan 27, 2026 | Prot_SAP_007.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent baseline recruitment | Oct 10, 2023 | Jan 8, 2026 | ICF_004.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent workshop participants | Oct 17, 2023 | Jul 31, 2025 | ICF_005.pdf |
| ICF | No | No | Yes | Informed Consent Form: Informed consent Screening | Oct 17, 2023 | Jul 31, 2025 | ICF_006.pdf |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
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Hybrid type III implementation-effectiveness cluster randomized controlled trial
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|
| Multicomponent hypertension intervention | Behavioral | The multicomponent hypertension intervention has four components as follows:
|
|
| Implementation outcomes [as per RE-AIM framework domain of Adoption ] | The proportion of GPs from 30 study clusters screening and providing hypertension management to hypertensive patients at BHU/RHC referred by LHW during the first 12 months Data source: GP checklists, Baseline/follow-up surveys | From enrollment to the first 12 months of Intervention |
| Implementation outcomes [as per RE-AIM framework domain of Implementation] | The mean number of the planned home visits/participant over 24 months (a maximum of sixteen visits, one every 3 months, are planned per participant) by LHW for HHE and BP monitoring Data source: LHWs' HHE and referral checklists, Baseline/follow-up surveys | From enrollment to the end of Intervention at 24 months |
| Implementation outcomes [as per RE-AIM framework domain of Implementation] | The mean number of healthcare contacts with GPs at the Basic Health Unit per participant over 24 months among those identified as having uncontrolled BP (SBP≥140 mm Hg and/or DBP≥90 mm Hg) by LHW at one or more than one occasion during the trial Data source: GP checklists, Baseline/follow-up surveys | From enrollment to the end of Intervention at 24 months |
| Implementation outcomes [as per RE-AIM framework domain of Maintenance] | The proportion of participants receiving visits by LHWs for HHE and BP monitoring at 6, 12, and 24 months. Data source: LHWs' HHE & referral checklists, Baseline/follow-up surveys | From enrollment to the end of Intervention at 24 months |
| Implementation outcomes [as per RE-AIM framework domain of Maintenance] | The proportion of participants that received advice and/or treatment from the GPs at the Basic Health Unit after being identified as having uncontrolled BP (SBP≥140 mm Hg and/or DBP≥90 mm Hg) by LHW at 6, 12, and 24 months. Data source: GP checklists, Baseline/follow-up surveys | From enrollment to the end of Intervention at 24 months |
| Effectiveness outcomes | Health-related quality of life i.e., EQ-5D-5L range, 0 to 100, with higher scores indicating better health. | From enrollment to the end of Intervention at 24 months |
| Effectiveness outcomes | The proportion of participants with blood-pressure control (SBP 140 mmHg and DBP 90 mmHg) | From enrollment to the end of Intervention at 24 months |
| 33190399 | Background | Turana Y, Tengkawan J, Chia YC, Nathaniel M, Wang JG, Sukonthasarn A, Chen CH, Minh HV, Buranakitjaroen P, Shin J, Siddique S, Nailes JM, Park S, Teo BW, Sison J, Ann Soenarta A, Hoshide S, Tay JC, Prasad Sogunuru G, Zhang Y, Verma N, Wang TD, Kario K; HOPE Asia Network. Hypertension and stroke in Asia: A comprehensive review from HOPE Asia. J Clin Hypertens (Greenwich). 2021 Mar;23(3):513-521. doi: 10.1111/jch.14099. Epub 2020 Nov 15. |
| 28097354 | Background | Forouzanfar MH, Liu P, Roth GA, Ng M, Biryukov S, Marczak L, Alexander L, Estep K, Hassen Abate K, Akinyemiju TF, Ali R, Alvis-Guzman N, Azzopardi P, Banerjee A, Barnighausen T, Basu A, Bekele T, Bennett DA, Biadgilign S, Catala-Lopez F, Feigin VL, Fernandes JC, Fischer F, Gebru AA, Gona P, Gupta R, Hankey GJ, Jonas JB, Judd SE, Khang YH, Khosravi A, Kim YJ, Kimokoti RW, Kokubo Y, Kolte D, Lopez A, Lotufo PA, Malekzadeh R, Melaku YA, Mensah GA, Misganaw A, Mokdad AH, Moran AE, Nawaz H, Neal B, Ngalesoni FN, Ohkubo T, Pourmalek F, Rafay A, Rai RK, Rojas-Rueda D, Sampson UK, Santos IS, Sawhney M, Schutte AE, Sepanlou SG, Shifa GT, Shiue I, Tedla BA, Thrift AG, Tonelli M, Truelsen T, Tsilimparis N, Ukwaja KN, Uthman OA, Vasankari T, Venketasubramanian N, Vlassov VV, Vos T, Westerman R, Yan LL, Yano Y, Yonemoto N, Zaki ME, Murray CJ. Global Burden of Hypertension and Systolic Blood Pressure of at Least 110 to 115 mm Hg, 1990-2015. JAMA. 2017 Jan 10;317(2):165-182. doi: 10.1001/jama.2016.19043. |
| 23597377 | Background | Gaglio B, Shoup JA, Glasgow RE. The RE-AIM framework: a systematic review of use over time. Am J Public Health. 2013 Jun;103(6):e38-46. doi: 10.2105/AJPH.2013.301299. Epub 2013 Apr 18. |
| 25889199 | Background | Powell BJ, Waltz TJ, Chinman MJ, Damschroder LJ, Smith JL, Matthieu MM, Proctor EK, Kirchner JE. A refined compilation of implementation strategies: results from the Expert Recommendations for Implementing Change (ERIC) project. Implement Sci. 2015 Feb 12;10:21. doi: 10.1186/s13012-015-0209-1. |
| 31036028 | Background | Waltz TJ, Powell BJ, Fernandez ME, Abadie B, Damschroder LJ. Choosing implementation strategies to address contextual barriers: diversity in recommendations and future directions. Implement Sci. 2019 Apr 29;14(1):42. doi: 10.1186/s13012-019-0892-4. |
| 36309746 | Background | Damschroder LJ, Reardon CM, Widerquist MAO, Lowery J. The updated Consolidated Framework for Implementation Research based on user feedback. Implement Sci. 2022 Oct 29;17(1):75. doi: 10.1186/s13012-022-01245-0. |
| 27189233 | Background | Kirk MA, Kelley C, Yankey N, Birken SA, Abadie B, Damschroder L. A systematic review of the use of the Consolidated Framework for Implementation Research. Implement Sci. 2016 May 17;11:72. doi: 10.1186/s13012-016-0437-z. |
| 22310560 | Background | Curran GM, Bauer M, Mittman B, Pyne JM, Stetler C. Effectiveness-implementation hybrid designs: combining elements of clinical effectiveness and implementation research to enhance public health impact. Med Care. 2012 Mar;50(3):217-26. doi: 10.1097/MLR.0b013e3182408812. |
| 33461967 | Background | Wolfenden L, Foy R, Presseau J, Grimshaw JM, Ivers NM, Powell BJ, Taljaard M, Wiggers J, Sutherland R, Nathan N, Williams CM, Kingsland M, Milat A, Hodder RK, Yoong SL. Designing and undertaking randomised implementation trials: guide for researchers. BMJ. 2021 Jan 18;372:m3721. doi: 10.1136/bmj.m3721. |
| 34593508 | Background | Skivington K, Matthews L, Simpson SA, Craig P, Baird J, Blazeby JM, Boyd KA, Craig N, French DP, McIntosh E, Petticrew M, Rycroft-Malone J, White M, Moore L. A new framework for developing and evaluating complex interventions: update of Medical Research Council guidance. BMJ. 2021 Sep 30;374:n2061. doi: 10.1136/bmj.n2061. |
| 28597375 | Background | Ostermann J, Brown DS, de Bekker-Grob EW, Muhlbacher AC, Reed SD. Preferences for Health Interventions: Improving Uptake, Adherence, and Efficiency. Patient. 2017 Aug;10(4):511-514. doi: 10.1007/s40271-017-0251-y. No abstract available. |
| 34426806 | Background | Heerden A, Ntinga X, Lippman SA, Leslie HH, Steward WT. Understanding the Factors that Impact Effective Uptake and Integration of Health Programs in South African Primary Health Care Clinics. Res Sq [Preprint]. 2021 Aug 17:rs.3.rs-783631. doi: 10.21203/rs.3.rs-783631/v1. |
| 30015069 | Background | Schwalm JR, McCready T, Lamelas P, Musa H, Lopez-Jaramillo P, Yusoff K, McKee M, Camacho PA, Lopez-Lopez J, Majid F, Thabane L, Islam S, Yusuf S. Rationale and design of a cluster randomized trial of a multifaceted intervention in people with hypertension: The Heart Outcomes Prevention and Evaluation 4 (HOPE-4) Study. Am Heart J. 2018 Sep;203:57-66. doi: 10.1016/j.ahj.2018.06.004. Epub 2018 Jun 22. |
| 32074419 | Background | 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. |
| 37316940 | Background | Elahi A, Ali AA, Khan AH, Samad Z, Shahab H, Aziz N, Almas A. Challenges of managing hypertension in Pakistan - a review. Clin Hypertens. 2023 Jun 15;29(1):17. doi: 10.1186/s40885-023-00245-6. |
| 29658619 | Background | Rafique I, Saqib MAN, Munir MA, Qureshi H, Rizwanullah, Khan SA, Fouad H. Prevalence of risk factors for noncommunicable diseases in adults: key findings from the Pakistan STEPS survey. East Mediterr Health J. 2018 Apr 5;24(1):33-41. |
| 31151358 | Background | Basit A, Tanveer S, Fawwad A, Naeem N; NDSP Members. Prevalence and contributing risk factors for hypertension in urban and rural areas of Pakistan; a study from second National Diabetes Survey of Pakistan (NDSP) 2016-2017. Clin Exp Hypertens. 2020;42(3):218-224. doi: 10.1080/10641963.2019.1619753. Epub 2019 May 31. |
| Background | Gaziano TAJPHACDPM: Cardiovascular diseases worldwide. 2022, 1:8-18. |
| 36051329 | Background | Mendis S, Graham I, Narula J. Addressing the Global Burden of Cardiovascular Diseases; Need for Scalable and Sustainable Frameworks. Glob Heart. 2022 Jul 29;17(1):48. doi: 10.5334/gh.1139. eCollection 2022. |
| 38213586 | Background | Hu B, Shi Y, Zhang P, Fan Y, Feng J, Hou L. Global, regional, and national burdens of hypertensive heart disease from 1990 to 2019 ：A multilevel analysis based on the global burden of Disease Study 2019. Heliyon. 2023 Nov 23;9(12):e22671. doi: 10.1016/j.heliyon.2023.e22671. eCollection 2023 Dec. |
| 40578881 | Derived | Naeem I, Almas A, Sheikh A, Hewitt C, Khwaja H, Afaq S, Bukhari S, Soofi S, S Virani S, Hanif S, Hashmi S, Walker S, Bhutta ZA, Siddiqi K, Samad Z. Multicomponent intervention for controlling hypertension in the adult rural population of Pakistan: a protocol for a hybrid type III implementation-effectiveness cluster randomised controlled trial. BMJ Open. 2025 Jun 27;15(6):e100365. doi: 10.1136/bmjopen-2025-100365. |
| Updated CFIR Constructs | View source |
| Use of Iterative PRISM and RE-AIM During Implementation | View source |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |