Ignite Creation Date:
2025-12-24 @ 6:49 PM
Ignite Modification Date:
2026-01-02 @ 1:24 PM
Study NCT ID:
NCT06726057
Status:
RECRUITING
Last Update Posted:
2025-02-21
First Post:
2024-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Implementing a Multi-component Hypertension Control Strategy in Rural Pakistan
Sponsor:
Aga Khan University
Organization:
Study Overview
Official Title:
A Multi-component Intervention for Controlling Hypertension in the Adult Rural Population of Pakistan: a Protocol for a Hybrid Type III Implementation-effectiveness Cluster Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2025-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 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 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).
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 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 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).
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: