NCT05038774

Brief Summary

An interventional study is designed and a structured educational session will be conducted regarding the management of Blood pressure for the general physicians of Karachi, Lahore, Peshawar, Islamabad, Multan and Quetta. The purpose of designing this study is to observe the effect of hypertension educational intervention for general physicians to improve patient outcomes indirectly. Results of this study may provide a basis for developing a hypertension educational program targeted at general physicians.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
126

participants targeted

Target at P50-P75 for not_applicable hypertension

Timeline
Completed

Started Sep 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 22, 2021

Completed
18 days until next milestone

First Posted

Study publicly available on registry

September 9, 2021

Completed
21 days until next milestone

Study Start

First participant enrolled

September 30, 2021

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2022

Completed
Last Updated

September 17, 2021

Status Verified

September 1, 2021

Enrollment Period

1.3 years

First QC Date

August 22, 2021

Last Update Submit

September 10, 2021

Conditions

Keywords

Educational InterventionHypertension ManagementPrimary Care Physician

Outcome Measures

Primary Outcomes (1)

  • Blood Pressure

    Pre \& Post change in the blood pressure control rate. Defined as percentage of patients with an average 12-hour blood pressure \<130/80 mmHg.

    3 Months

Secondary Outcomes (2)

  • Knowledge of GPs about Hypertension Management

    3 Months

  • Knowledge of Patients about Hypertension Management

    3 Months

Study Arms (2)

Interventional group

EXPERIMENTAL

GPs of the Interventional group will receive (1 day) face to face education with structured educational material on strategies of hypertension management by a senior cardiologist.

Other: Face to face Educational Training

Control group

ACTIVE COMPARATOR

GPs of the Control group will receive print version of education material (Structured educational material) on strategies of structured hypertension management.

Other: Printed Education Material

Interventions

1. Key points of current hypertension guidelines. 2. 10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines. 3. template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients. 4. checklists to assist in the diagnosis of secondary hypertension. 5. Patient information leaflet about hypertension.

Interventional group

1. Key points of current hypertension guidelines. 2. 10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines. 3. template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients. 4. checklists to assist in the diagnosis of secondary hypertension. 5. Patient information leaflet about hypertension.

Control group

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • GPs who have at least three years of practice experience in the broad disciplines of primary care using the Numerical Pain Rating (NPR) scale over the past week ≥ 2 on a 0-10 numerical pain scale.
  • Patients between 18-60 years.
  • Patients with uncontrolled blood pressure according to Pakistan hypertension league guidelines
  • Patients with or without angiographically proven coronary, peripheral or cerebral vascular disease.
  • Patients must be able to give informed consent and be able to read and comprehend in the Urdu (National Language)
  • Patients must have a digital BP apparatus at home.
  • Patients must have a phone with camera and internet.

You may not qualify if:

  • GPs who had attended a planned Hypertension educational program during the last 6 months.
  • Patients with a recognized psychiatric disorder as per the Diagnostic and Statistical Manual of Mental Disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karachi institute of heart disease

Karachi, Sindh, 78500, Pakistan

Location

Related Publications (5)

  • Ezzati M, Lopez AD, Rodgers A, Vander Hoorn S, Murray CJ; Comparative Risk Assessment Collaborating Group. Selected major risk factors and global and regional burden of disease. Lancet. 2002 Nov 2;360(9343):1347-60. doi: 10.1016/S0140-6736(02)11403-6.

    PMID: 12423980BACKGROUND
  • Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.

    PMID: 15053002BACKGROUND
  • Tu K, Chen Z, Lipscombe LL; Canadian Hypertension Education Program Outcomes Research Taskforce. Prevalence and incidence of hypertension from 1995 to 2005: a population-based study. CMAJ. 2008 May 20;178(11):1429-35. doi: 10.1503/cmaj.071283.

    PMID: 18490638BACKGROUND
  • Marques-Vidal P, Tuomilehto J. Hypertension awareness, treatment and control in the community: is the 'rule of halves' still valid? J Hum Hypertens. 1997 Apr;11(4):213-20. doi: 10.1038/sj.jhh.1000426.

    PMID: 9185025BACKGROUND
  • Primatesta P, Brookes M, Poulter NR. Improved hypertension management and control: results from the health survey for England 1998. Hypertension. 2001 Oct;38(4):827-32.

    PMID: 11641294BACKGROUND

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Central Study Contacts

Tariq Ashraf, FCPS

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

August 22, 2021

First Posted

September 9, 2021

Study Start

September 30, 2021

Primary Completion

December 31, 2022

Study Completion

December 31, 2022

Last Updated

September 17, 2021

Record last verified: 2021-09

Locations