Ignite Creation Date:
2024-05-05 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00217334
Status:
COMPLETED
Last Update Posted:
2005-09-22
First Post:
2005-09-19
Brief Title:
Community Hypertension Assessment Trial CHAT
Sponsor:
Hamilton Health Sciences Corporation
Organization:
McMaster University
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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 andor 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 mobilewell 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
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 andor 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 mobilewell 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| McMaster CSD 2001HO4527 | None | None | None |
| CIHR MOP 57902 | None | None | None |