HypertensionNCT05038774
Educational Intervention for Hypertension Management
A study testing Face to face Educational Training and Printed Education Material in people with Hypertension, run by University of Karachi at 1 site in Pakistan.
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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Face to face Educational Training and Printed Education Material
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 sitePakistan
- Study dates
- 30 Sep 2021to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Karachi institute of heart disease
Karachi, Sindh, 78500
Tariq Ashraf, FCPS, 03222999914
About this study
Official title: 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.
Read the 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)
- Conditions
- Hypertension
- Being tested
- Face to face Educational Training, Printed Education Material
- Keywords
- Educational Intervention, Hypertension Management, Primary Care Physician
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Face to face Educational TrainingOther
- 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 MaterialOther
- 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Printed Education Material |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 Months
Secondary outcomes (2)
Knowledge of GPs about Hypertension Management
Pre \& Post knowledge enhancement of GPs regarding hypertension management.
Measured: 3 Months
Knowledge of Patients about Hypertension Management
Pre \& Post knowledge enhancement of patients regarding hypertension
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2021
- Study start30 Sep 2021 (estimated)
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Karachi
- Sponsor type
- University, hospital or other
- Collaborators
- Advanced Education & Research Center
- Responsible party
- Principal investigator, Prof. Dr. Tariq Ashraf, University of Karachi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05038774
- Sponsor's protocol ID
- PUMPKG
- Status last verified
- Sep 2021
- First submitted
- 22 Aug 2021
- Last updated
- 17 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 12423980Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
PubMed 15053002Tu 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.
PubMed 18490638Marques-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.
PubMed 9185025Primatesta 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.
PubMed 11641294
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Educational Intervention on Hypertension Management by Primary Care Physician (Pump)
- ClinicalTrials.gov ID
- NCT05038774
- Acronym / sponsor ID
- PUMPKG
- Conditions
- Hypertension
- Keywords
- Educational Intervention, Hypertension Management, Primary Care Physician
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of KarachiUniversity, hospital or other
- Collaborators
- Advanced Education & Research Center
- Study start
- 30 Sep 2021 (estimated)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interventional group | Experimental | Other: Face to face Educational TrainingGPs 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. |
| Control group | Active comparator | Other: Printed Education MaterialGPs of the Control group will receive print version of education material (Structured educational material) on strategies of structured hypertension management. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Face to face Educational Training1. 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. | Other | Interventional group |
| Printed Education Material1. 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. | Other | Control group |
Primary outcome
Blood Pressure
Time frame: 3 Months
Pre \& Post change in the blood pressure control rate. Defined as percentage of patients with an average 12-hour blood pressure <130/80 mmHg.
2 secondary outcomes
Knowledge of GPs about Hypertension Management
Time frame: 3 Months
Knowledge of Patients about Hypertension Management
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2021.
- Background: PubMed 12423980Ezzati 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.
- Background: PubMed 15053002Lawes CM, Bennett DA, Feigin VL, Rodgers A. Blood pressure and stroke: an overview of published reviews. Stroke. 2004 Apr;35(4):1024.
- Background: PubMed 18490638Tu 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.
- Background: PubMed 9185025Marques-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.
- Background: PubMed 11641294Primatesta 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Face to face Educational Training and Printed Education Material in people with Hypertension, run by University of Karachi at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Tariq Ashraf, FCPS (03222999914, tariqash45@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood Pressure (time frame: 3 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05038774, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2021.