Educational Intervention for Hypertension Management

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05038774
• Other study ID #: PUMPKG
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 30, 2021
• Est. completion date: December 31, 2022

Study information

• Verified date: September 2021
• Source: University of Karachi
• Contact: Tariq Ashraf, FCPS
• Phone: 03222999914
• Email: tariqash45[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 126
• Est. completion date: December 31, 2022
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Hypertension

Intervention

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.
• 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.

Locations

Country	Name	City	State
Pakistan	Karachi institute of heart disease	Karachi	Sindh

Sponsors (2)

Lead Sponsor	Collaborator
University of Karachi	Advanced Education & Research Center

Country where clinical trial is conducted

Pakistan, 

References & 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. Review. — View Citation

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

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Knowledge of GPs about Hypertension Management	Pre & Post knowledge enhancement of GPs regarding hypertension management.	3 Months
Secondary	Knowledge of Patients about Hypertension Management	Pre & Post knowledge enhancement of patients regarding hypertension	3 Months