DCP3 Based Multi-component Intervention for Hypertension Management and Control

NCT ID: NCT04336631

Last Updated: 2020-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-03-30

Brief Summary

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This study aims to enable delivery of a multi-component intervention comprising of strategies based on Disease Control Priorities 3rd edition for management of hypertension among hypertensive patients. The secondary objective is to test the feasibility, acceptability and adaptability of a multi-component intervention delivered at a tertiary level health-care facility in the cultural context of Pakistan. A formative research study was conducted before so as to develop and test the intervention in a tertiary care hospital setting. The investigators employed qualitative research methods to explore the feasibility, applicability, and acceptance of DCP3 based intervention comprising of strategies for hypertension management. Focus group discussions and in-depth interviews with selected study participants were conducted at Armed Forces Institute of Cardiology (AFIC/NIHD), Rawalpindi for which a prior written and verbal consent was obtained from all research participants. The study adhered to the ethical principles of involving human subjects in the research. All information provided by the participants was recorded and was kept strictly confidential.

Detailed Description

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Conditions

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Hypertension Hypertensive Patients

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Routine Medical Follow Up, Counseling & Usual Care

Behavioral counseling was provided to the patients on each consecutive follow up after enrolling in this study. They were adequately followed on physical exercise, reduced salt intake, lifestyle modifications, and smoking cessation. All measurements of blood pressure and weight were maintained and recorded.

Group Type OTHER

Intervention on DCP3 based strategies for Hypertension Management and Control

Intervention Type BEHAVIORAL

Intervention on DCP3 based strategies for Hypertension Management and Control was developed after formative research findings and evidence built on desk review which was conducted prior to implementation of the multi-componnet strategy. It was tested and implemented in a tertiary care hospital of cardiology among hypertensive patients visiting out-patient department in Rawalpindi, Pakistan.

Routine Medical Follow Up & Usual Care

Usual routine medical care was provided to the study participants only.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Intervention on DCP3 based strategies for Hypertension Management and Control

Intervention on DCP3 based strategies for Hypertension Management and Control was developed after formative research findings and evidence built on desk review which was conducted prior to implementation of the multi-componnet strategy. It was tested and implemented in a tertiary care hospital of cardiology among hypertensive patients visiting out-patient department in Rawalpindi, Pakistan.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* • Pakistani nationals both male and female of age 18 years and above will be invited to participate in the study

* Similarly; known hypertensive patients having a systolic blood pressure of ≥140 mmHg on current treatment will be included \&
* Patients with co-morbidities will also be included such as those suffering from cardiac ailments (angina or transient ischemic attack (TIA) and diabetes

Exclusion Criteria

* • Patients with compromised neurological or cognitive state who are unable to provide their consent will be excluded

* Patients suffering from non-cardiovascular diseases and life-threatening illnesses such as angiographically proven coronary disease, peripheral or cerebral vascular disease, pulmonary hypertension, having history of myocardial infarction, stroke/PCI/stent or high-risk conditions will be excluded from participation
* Patients with chronic conditions and co-morbidities requiring surgical intervention or treatment such as cardiomyopathies or congenital abnormalities \&
* Patients receiving dialysis will also be excluded from the study
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Health Services Academy, Islamabad, Pakistan

OTHER

Sponsor Role lead

Responsible Party

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Subhana Akber Khan

Principal Investigator PhD Scholar (Public Health)

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Armed Forces Institute of Cardiology (AFIC/NIHD)

Rawalpindi, <Select>, Pakistan

Site Status

Countries

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Pakistan

References

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Khan SA, Hafeez A, Zaka A, Khan SA, Ahmed A, Pervaiz F, Siddiqui AH. A Randomized Controlled Trial of Blood Pressure Reduction Based on Disease Control Priorities 3 in Pakistan to Manage and Control Hypertension. High Blood Press Cardiovasc Prev. 2023 Jul;30(4):357-366. doi: 10.1007/s40292-023-00589-y. Epub 2023 Jul 26.

Reference Type DERIVED
PMID: 37493898 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Related Links

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Other Identifiers

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NCT 2224/2017

Identifier Type: -

Identifier Source: org_study_id

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