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Sponsors and Collaborators: |
Hamilton Health Sciences University of Ottawa |
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Information provided by: | McMaster University |
ClinicalTrials.gov Identifier: | NCT00217334 |
The Community Hypertension Assessment Trial (CHAT) is an investigation of the effect of community pharmacy based blood pressure (BP) monitoring sessions led by peer health educators, with feedback to family physicians, on the monitoring and management of blood pressure among older adults.
Condition | Intervention |
---|---|
Hypertension |
Behavioral: Volunteer-led pharmacy sessions with feedback to physicians |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment |
Official Title: | A Pragmatic Trial of Community Pharmacy Blood Pressure Clinics Linked With Family Medicine Practices to Improve the Monitoring and Management of High Blood Pressure Among Older Adults |
Estimated Enrollment: | 28 |
Study Start Date: | November 2002 |
Estimated Study Completion Date: | January 2005 |
Hypertension affects about 22% of Canadian adults and is a modifiable risk factor for cardiovascular disease. Most countries have increasing older adult populations and hypertension prevalence increases with age. However, the “rule of halves” still applies in many primary health care settings: half of the hypertensive patients are undiagnosed, half of the diagnosed patients are untreated, and half of the treated patients are uncontrolled.
Family physicians were randomly selected and approached to participate in CHAT. Paired cluster randomization was used, with practices as the unit of randomization. Data on blood pressure (BP) readings in the last year, diagnosis of hypertension, diagnosis of diabetes and/or target organ damage, and a current antihypertensive profile was extracted from the health records of 55 patients randomly selected in each practice. In practices allocated to the Intervention group, physicians sent a letter, with assistance from research staff, to invite all of their eligible patients 65 years and older to attend one or two BP sessions in nearby pharmacies. Inclusion criteria required that patients be regular patients in the practice, community-dwelling, and mobile/well enough to attend community sessions.
Public health authorities trained older adult volunteer peer health educators to assist patients at the sessions to accurately measure their BP using a validated automated device, and record BP readings and cardiovascular risk factors. The volunteers provided education about hypertension but did not perform a clinical function. A recommendation protocol ensured that the pharmacist and, if necessary, the physician was notified if patients had a very high BP or a very low BP accompanied by symptoms. A public health nurse was ‘on-call’ during the sessions in case clinical advice was needed. A volunteer coordinator facilitated the transfer of readings and patient-reported cardiovascular risk factors to physicians.
Accurate BP readings were obtained from the BPM-100 automated BP measuring device. Questionnaires were used to obtain self-report data on cardiovascular disease risk factors from patients, knowledge and attitudes about BP control from physicians, and attitudes and satisfaction with the program from peer health educators, pharmacists, and public health nurses.
The primary outcome measure followed an 'intention to treat' approach. The primary endpoint was the difference in the change from 12 months pre- to 12 months post-intervention in the proportion of eligible patients with a BP reading recorded in their health record with mean systolic <=140 mm Hg or mean diastolic <=90 mmHg; <=130 or <=80 if target organ damage or diabetes is present.
This trial is a collaboration by the Department of Family Medicine, McMaster University and the Elisabeth Bruyère Research Institute, a University of Ottawa and SCO Service Partnership.
Ages Eligible for Study: | 65 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
28 family physicians were recruited; all eligible patients in practices allocated to the intervention arm were invited to the program. A randomly selected set of 50 charts per practice were audited, regardless of session attendance.
Physician Practices
Inclusion Criteria:
Exclusion Criteria:
Patients
Inclusion Criteria:
Exclusion Criteria:
Canada, Ontario | |
McMaster University | |
Hamilton, Ontario, Canada, L8N 3Z5 |
Principal Investigator: | Janusz A Kaczorowski, PhD | McMaster University |
Principal Investigator: | Larry W Chambers, PhD | Elisabeth Bruyere Research Institute |
Study ID Numbers: | 0517-149-02, CIHR MOP 57902, McMaster CSD 2001HO4527 |
Study First Received: | September 19, 2005 |
Last Updated: | September 19, 2005 |
ClinicalTrials.gov Identifier: | NCT00217334 |
Health Authority: | Canada: Health Canada |
Hypertension Cardiovascular diseases Randomized controlled trial Cluster randomization Primary care |
Vascular Diseases Hypertension |
Cardiovascular Diseases |