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DCP3 Based Multi-component Intervention for Hypertension Management and Control

Primary Purpose

Hypertension, Hypertensive Patients

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Intervention on DCP3 based strategies for Hypertension Management and Control
Sponsored by
Health Services Academy, Islamabad, Pakistan
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hypertension

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Armed Forces Institute of Cardiology (AFIC/NIHD)

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

No Intervention

Arm Label

Routine Medical Follow Up, Counseling & Usual Care

Routine Medical Follow Up & Usual Care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months
Number of participants with reduced salt intake from baseline measurements as compared to follow up measurements at 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Number of participants with increased level of physical exercise compared from baseline measurements to follow up measurements at 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Number of participants with regular compliance to medications from baseline measurement compared with follow up measurements at 03 months
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.

Secondary Outcome Measures

Full Information

First Posted
April 1, 2020
Last Updated
April 6, 2020
Sponsor
Health Services Academy, Islamabad, Pakistan
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1. Study Identification

Unique Protocol Identification Number
NCT04336631
Brief Title
DCP3 Based Multi-component Intervention for Hypertension Management and Control
Official Title
Implementation of DCP3 Strategies to Manage and Control Hypertension Among Hypertensive Patients in Pakistan: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
January 1, 2020 (Actual)
Study Completion Date
March 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Health Services Academy, Islamabad, Pakistan

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypertensive Patients

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Routine Medical Follow Up, Counseling & Usual Care
Arm Type
Other
Arm Description
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.
Arm Title
Routine Medical Follow Up & Usual Care
Arm Type
No Intervention
Arm Description
Usual routine medical care was provided to the study participants only.
Intervention Type
Behavioral
Intervention Name(s)
Intervention on DCP3 based strategies for Hypertension Management and Control
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months
Time Frame
03 months
Title
Number of participants with reduced salt intake from baseline measurements as compared to follow up measurements at 03 months
Description
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Time Frame
Baseline to follow up in 03 months
Title
Number of participants with increased level of physical exercise compared from baseline measurements to follow up measurements at 03 months
Description
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Time Frame
03 months
Title
Number of participants with regular compliance to medications from baseline measurement compared with follow up measurements at 03 months
Description
This was assessed at each consecutive follow up of hypertensive patients for reduced salt intake and increased physical exercise. Hypertensive patients were also counselled for regular intake of medicines prescribed by the physician. A record for the mentioned measurements was kept and maintained from baseline to 03 months of the trial.
Time Frame
03 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Armed Forces Institute of Cardiology (AFIC/NIHD)
City
Rawalpindi
State/Province
<Select>
ZIP/Postal Code
74200
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Links:
URL
http://www.pafmj.org/index.php/PAFMJ/article/view/3932/2548
Description
A Study Protocol on Hypertension

Learn more about this trial

DCP3 Based Multi-component Intervention for Hypertension Management and Control

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