Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ANZCTR |
Last refreshed on:
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29 March 2021 |
Main ID: |
ACTRN12614000641695 |
Date of registration:
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18/06/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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An interventional study on physicians’ adherence to hypertension guidelines
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Scientific title:
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Effect of a complex intervention involving primary care doctors on blood pressure control in patients with hypertension |
Date of first enrolment:
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07/10/2013 |
Target sample size:
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570 |
Recruitment status: |
Completed |
URL:
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https://anzctr.org.au/ACTRN12614000641695.aspx |
Study type:
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Interventional |
Study design:
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Purpose: Prevention; Allocation: Non-randomised trial; Masking: Open (masking not used);Assignment: Single group;Type of endpoint: Efficacy;
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Phase:
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Not Applicable
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Countries of recruitment
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Malaysia
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Contacts
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Name:
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Prof Ee Ming Khoo
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Address:
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Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai
50603, Kuala Lumpur,
Malaysia |
Telephone:
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+603 79492306 |
Email:
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khooem@um.edu.my |
Affiliation:
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Name:
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Prof Ee Ming Khoo
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Address:
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Department of Primary Care Medicine,
Faculty of Medicine,
University of Malaya,
Jalan Lembah Pantai
50603, Kuala Lumpur,
Malaysia |
Telephone:
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+603 79492306 |
Email:
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khooem@um.edu.my |
Affiliation:
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Key inclusion & exclusion criteria
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Inclusion criteria: All primary care physician working at the Primary Care Clinic at the University Malaya Medical Centre (UMMC) who are treating the cohort of patients with hypertension from earlier phase of this study (patient with hypertension for at least a year and have been followed up at the Primary Care Clinic).
Earlier phase of the study is a retrospective review of records and it is not registered as it is not an intervention trial. We have published a paper from earlier phase of the study :
Liew et al.: Statins use is associated with poorer
glycaemic control in a cohort of hypertensive patients with diabetes and without diabetes. Diabetology & Metabolic Syndrome 2014 6:53. doi:10.1186/1758-5996-6-53
Exclusion criteria: All primary care physician working at the Primary Care Clinic at the University Malaya Medical Centre (UMMC) who are not treating the cohort of patients with hypertension from earlier phase of the study
Age minimum:
No limit
Age maximum:
No limit
Gender:
Both males and females
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Health Condition(s) or Problem(s) studied
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Public Health - Health service research
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Cardiovascular - Hypertension
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Hypertension; Hypertension
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Intervention(s)
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This is a before-and-after study using clinical support tools and health care professional training. Assessments are done at 0-3 months post intervention for immediate effect of intervention and 3-6 months post interventions for sustainability of intervention.
The intervention package consists of :
1. A training session conducted by senior academicians to modify the primary care physicians' practice according to guidelines recommendations pre intervention
2. A quick reference guide summarising recommendations from the guideline to put on desktops as well as online on computers of each consultation room for easy access and reference for doctors throughout the study duration
3. At patient's first visit: (i) Patients have to fill self assessment forms prior to consultation with doctor (ii) Patients' anthropometric parameters (weight, height and waist circumference) are measured by nurses (iii) A personalized checklist for the doctors is placed in the patient's medical record to be utilized as a quick reference and reminder to the doctor on the essential parameters that are required for evaluation. The checklist includes documentation of cardiovascular risk factors and comorbidities, secondary causes, investigations ordered, target organ damage, patient's estimated cardiovascular risk, medications, BP measurement and physcical examination findings. (iv) Sets of investigations forms are placed in the medical records as reminder for doctors and for ease of administration
4. At patients' follow up visits at 3 to 6 months, a checklist is placed in the medical records that includes documentation of weight, blood pressure, investigations ordered, medications, presence of target organ damage and complications.
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Primary Outcome(s)
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Primary outcome is the proportion of patients with controlled blood pressure. Controlled blood pressure is defined as blood pressure less than 140/90mmHg and measured using mercury sphygmomanometer by the doctors. [0 to 3 months post intervention for immediate effect of intervention, 3 to 6 months post intervention for sustainability of intervention]
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Secondary Outcome(s)
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The rates of documentation of process indicators and outcome indicators from the checklist provided in the medical records: these include the rate of documentation of process indicators (BP, weight measurement, assessment of cardiovascular risk factors, target organ damage and comorbidities, examinations, investigatory tests ordered) and the rate of documentation of outcome indicators (medication use) [0 to 3 months post intervention for immediate effect of intervention, 3 to 6 months post intervention for sustainability of intervention]
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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University Malaya Research Grant (UMRG) 513- 13 HTM, Institute of Research Management and Monitoring (IPPP), University of Malaya, Malaysia
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University Malaya Research Grant (UMRG) 315- 11 HTM, Institute of Research Management and Monitoring (IPPP), University of Malaya, Malaysia
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Ethics review
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Status: Approved
Approval date: 23/11/2011
Contact:
Medical Ethics Committee, University Malaya Medical Centre (UMMC)
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Results
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Results available:
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Yes |
Date Posted:
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19/03/2021 |
Date Completed:
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15/05/2014 |
URL:
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