Educational Intervention for Hypertension Management

Impact of Educational Intervention on Hypertension Management by Primary Care Physician (Pump)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Hypertension
• Intervention / Treatment: Other: Face to face Educational Training; Other: Printed Education Material

Detailed Description

Study Procedure

1. Screening of General physicians as per inclusion criteria and recruitment of GPs by clinical research associate after obtaining informed consent form.
2. GPs will be asked to fill hypertension awareness questionnaire at baseline
3. Both group of GPs with the help of clinical research associate will recruit 5 patients from study site.
4. After obtaining informed consent, Patient will be asked to fill hypertension awareness questionnaire at baseline or recruitment day and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate.
5. Randomization of GPs will be than in to 2 Groups.
6. After randomization, Group 1 GPs will receive (1 day) face to face education and Group 2 GPs will receive print version of education material.
7. After GPs education intervention, patients will be invited for regular checkup at GPs clinic.
8. Patient will be again asked to fill hypertension awareness questionnaire after 3 months and share pictures of 12-hour blood pressure measurement (from digital BP apparatus) with clinical research associate. (1st, 2nd & 3rd Month).
9. GPs will be asked to fill hypertension awareness questionnaire again after 3 months (Post intervention)

• Study Type: Interventional
• Enrollment (Anticipated): 126
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Tariq Ashraf, FCPS; Phone Number: 03222999914; Email: tariqash45@gmail.com

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 78500
      • Karachi institute of heart disease
      • Contact: Tariq Ashraf, FCPS; Phone Number: 03222999914

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interventional group; 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; Key points of current hypertension guidelines.; 10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines.; template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients.; checklists to assist in the diagnosis of secondary hypertension.; Patient information leaflet about hypertension.
Active Comparator: Control group; 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; Key points of current hypertension guidelines.; 10-step checklist how to obtain standardized upper arm blood pressure readings according to guidelines.; template of a blood pressure documentation sheet for serial documentation of blood pressure values by patients.; checklists to assist in the diagnosis of secondary hypertension.; Patient information leaflet about hypertension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Knowledge of GPs about Hypertension Management	Pre & Post knowledge enhancement of GPs regarding hypertension management.	3 Months
Knowledge of Patients about Hypertension Management	Pre & Post knowledge enhancement of patients regarding hypertension	3 Months

Collaborators and Investigators

• Sponsor: University of Karachi
• Collaborators: Advanced Education & Research Center

Publications and helpful links

General Publications

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

Study record dates

Study Major Dates

• Study Start (Anticipated): September 30, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): December 31, 2022

Study Registration Dates

• First Submitted: August 22, 2021
• First Submitted That Met QC Criteria: September 2, 2021
• First Posted (Actual): September 9, 2021

Study Record Updates

• Last Update Posted (Actual): September 17, 2021
• Last Update Submitted That Met QC Criteria: September 10, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: Educational Intervention; Hypertension Management; Primary Care Physician
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: PUMPKG

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No