ClinicalTrials.gg
CompletedNCT04336631Updated Apr 8, 2020

DCP3 Based Multi-component Intervention for Hypertension Management and Control

An interventional study of Intervention on DCP3 based strategies for Hypertension Management and Control in Hypertension and Hypertensive Patients, sponsored by Health Services Academy, Islamabad, Pakistan. Completed at 1 site in Pakistan. Per ClinicalTrials.gov, last updated 2020-04-08.

Sponsored by Health Services Academy, Islamabad, Pakistan · Not applicable, Interventional, and Screening

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Nov 2019, registered Apr 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
500
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Hypertension
  • Hypertensive Patients

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03

In context

Hypertension

6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.

This study's enrollment of 500 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.

Browse Hypertension studies →

Lead sponsor

Health Services Academy, Islamabad, Pakistan is the lead sponsor of 7 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 (TIA) and diabetes

Exclusion criteria

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
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

TIA (transient ischaemic attack)

A “mini-stroke”: temporary stroke-like symptoms caused by reduced blood flow to part of the brain, spinal cord or eye, without signs of a new stroke on a scan.

Stroke symptoms need emergency care at once, even if they go away.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
500 participants (actual)

Study arms

  • Other
    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.

    Behavioral: Intervention on DCP3 based strategies for Hypertension Management and Control

  • No intervention
    Routine Medical Follow Up & Usual Care

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

Interventions

  • BehavioralIntervention 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.

06

What researchers measure

Primary outcomes

  1. Number of participants with adequate blood pressure control in the intervention arm after delivering the intervention at 03 months

    Time frame: 03 months

  2. 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.

    Time frame: Baseline to follow up in 03 months

  3. 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.

    Time frame: 03 months

  4. 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.

    Time frame: 03 months

07

Study locations

1 site
  • Armed Forces Institute of Cardiology (AFIC/NIHD)
    Rawalpindi, <Select> 74200, Pakistan
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Yes

Supporting information: Study protocol, Informed consent form

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Nov 2019 to primary completion in Jan 2020, 2 months.

Of 1,403 non-industry interventional studies with no phase under Hypertension, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 41. This study's 2 months is below that.

Counting every sponsor, half of 1,498 studies reached it within 23 months; a quarter within 10 and three quarters within 41.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 1, 2020
First posted
Apr 7, 2020
StartActual
Nov 1, 2019
Primary completionActual
Jan 1, 2020
CompletionActual
Mar 30, 2020
Last update
Apr 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04336631
Lead sponsor
Health Services Academy, Islamabad, Pakistan
Responsible party
Subhana Akber Khan (Principal Investigator PhD Scholar (Public Health), Health Services Academy, Islamabad, Pakistan) — Principal investigator
First posted
Apr 7, 2020
Start date
Nov 1, 2019
Primary completion
Jan 1, 2020
Completion
Mar 30, 2020
Last update
Apr 8, 2020

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

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