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Educational Intervention for Hypertension Management

Primary Purpose

Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Face to face Educational Training
Printed Education Material
Sponsored by
University of Karachi
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Hypertension focused on measuring Educational Intervention, Hypertension Management, Primary Care Physician

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Karachi institute of heart disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Interventional group

Control group

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Knowledge of GPs about Hypertension Management
Pre & Post knowledge enhancement of GPs regarding hypertension management.
Knowledge of Patients about Hypertension Management
Pre & Post knowledge enhancement of patients regarding hypertension

Full Information

First Posted
August 22, 2021
Last Updated
September 10, 2021
Sponsor
University of Karachi
Collaborators
Advanced Education & Research Center
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1. Study Identification

Unique Protocol Identification Number
NCT05038774
Brief Title
Educational Intervention for Hypertension Management
Official Title
Impact of Educational Intervention on Hypertension Management by Primary Care Physician (Pump)
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 30, 2021 (Anticipated)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Karachi
Collaborators
Advanced Education & Research Center

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
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.
Detailed Description
Study Procedure Screening of General physicians as per inclusion criteria and recruitment of GPs by clinical research associate after obtaining informed consent form. GPs will be asked to fill hypertension awareness questionnaire at baseline Both group of GPs with the help of clinical research associate will recruit 5 patients from study site. 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. Randomization of GPs will be than in to 2 Groups. After randomization, Group 1 GPs will receive (1 day) face to face education and Group 2 GPs will receive print version of education material. After GPs education intervention, patients will be invited for regular checkup at GPs clinic. 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). GPs will be asked to fill hypertension awareness questionnaire again after 3 months (Post intervention)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension
Keywords
Educational Intervention, Hypertension Management, Primary Care Physician

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
126 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Interventional group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
GPs of the Control group will receive print version of education material (Structured educational material) on strategies of structured hypertension management.
Intervention Type
Other
Intervention Name(s)
Face to face Educational Training
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Printed Education Material
Intervention Description
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.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Pre & Post change in the blood pressure control rate. Defined as percentage of patients with an average 12-hour blood pressure <130/80 mmHg.
Time Frame
3 Months
Secondary Outcome Measure Information:
Title
Knowledge of GPs about Hypertension Management
Description
Pre & Post knowledge enhancement of GPs regarding hypertension management.
Time Frame
3 Months
Title
Knowledge of Patients about Hypertension Management
Description
Pre & Post knowledge enhancement of patients regarding hypertension
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tariq Ashraf, FCPS
Phone
03222999914
Email
tariqash45@gmail.com
Facility Information:
Facility Name
Karachi institute of heart disease
City
Karachi
State/Province
Sindh
ZIP/Postal Code
78500
Country
Pakistan
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tariq Ashraf, FCPS
Phone
03222999914

12. IPD Sharing Statement

Citations:
PubMed Identifier
12423980
Citation
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.
Results Reference
background
PubMed Identifier
15053002
Citation
Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
Results Reference
background
PubMed Identifier
18490638
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.
Results Reference
background
PubMed Identifier
9185025
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. doi: 10.1038/sj.jhh.1000426.
Results Reference
background
PubMed Identifier
11641294
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.
Results Reference
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Educational Intervention for Hypertension Management

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