Educational Intervention for Hypertension Management

NCT ID: NCT05038774

Last Updated: 2021-09-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

126 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-09-30

Study Completion Date

2022-12-31

Brief Summary

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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

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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)

Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Face to face Educational Training

Intervention Type OTHER

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

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

Group Type ACTIVE_COMPARATOR

Printed Education Material

Intervention Type OTHER

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.

Interventions

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Face to face Educational Training

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.

Intervention Type OTHER

Printed Education Material

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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Advanced Education & Research Center

OTHER

Sponsor Role collaborator

University of Karachi

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Tariq Ashraf

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Karachi institute of heart disease

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Central Contacts

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Tariq Ashraf, FCPS

Role: CONTACT

03222999914

Facility Contacts

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Tariq Ashraf, FCPS

Role: primary

03222999914

References

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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.

Reference Type BACKGROUND
PMID: 12423980 (View on PubMed)

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

Reference Type BACKGROUND
PMID: 15053002 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18490638 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 9185025 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11641294 (View on PubMed)

Other Identifiers

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PUMPKG

Identifier Type: -

Identifier Source: org_study_id

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