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| [ ...Back to search results ] | [ Print-friendly version ] |
| Community Cardiovascular Health Awareness Program |
| ISRCTN | ISRCTN50550004 |
| ClinicalTrials.gov identifier | |
| Public title | Community Cardiovascular Health Awareness Program |
| Scientific title | |
| Acronym | C-CHAP |
| Serial number at source | 06-205 |
| Study hypothesis | Community-based volunteer-operated, Cardiovascular Health Awareness Program (CHAP), with assessment of Blood Pressure (BP) and other Cardiovascular Disease (CVD) risk factors at pharmacy sessions, that are linked with Family Physicians (FPs) and pharmacists, can improve the cardiovascular health of older adults in Ontario communities, yielding a statistically and clinically significant reduction in the mean rate of hospital admissions (mean rate of change from the year preceding the program) for acute myocardial infarction, congestive heart failure, and stroke (composite end point), for the entire population of residents 65 years and older during the year following implementation of CHAP, compared to control communities. |
| Lay summary | |
| Ethics approval | Final approval received from the Hamilton Health Sciences/McMaster University Faculty of Health Sciences Research Ethics Board on the 11th July 2006 (ref: 06-205). |
| Study design | C-CHAP is a prospective stratified cluster randomised controlled trial to evaluate the effectiveness of CHAP in medium-sized communities across Ontario |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Cardiovascular disease risk factors |
| Participants - inclusion criteria | The 39 eligible communities vary in population size from 10,000 to 60,000, and were stratified by population aged 65+ and geographic location, and randomly allocated to CHAP or control. The community mobilisation model aims to involve all family physicians, local pharmacies and relevant organisations in the program communities. The program targets all residents 65 years of age or older through community-wide advertising and invitation via family physicians. |
| Participants - exclusion criteria |
1. Communities of less than 10,000 residents
2. Fewer than five family physicians and two pharmacies in community |
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/03/2009 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 30% of seniors in program communities |
| Interventions |
The community pharmacy sessions are weekday three-hour morning sessions over a ten-week period, which entail volunteer Peer Health Educators ensuring that accurate BP recordings and risk factor data are collected for delivery to FPs, pharmacists, and session participants, and providing patient-specific cardiovascular disease risk factor education. Older adult residents of the program communities are invited to attend at least two sessions over the course of the program. Multiple strategies are used to invite older adults to the CHAP sessions, including letters and hand-outs from their FPs, flyers and posters distributed throughout the community, and direct advertising through local media.
Participants' FPs receive immediate notification of BPs exceeding 180/120 mmHg (previously shown to occur in about 3% of cases), and a toll-free fax-to-database system is used to forward all other session results to FPs and pharmacists at the end of the ten-week program in the form of reports listing their patients by BP, treatment status, and cardiovascular risk. Pharmacists will be involved in consulting with patients as needed both during and outside of sessions about their medication (e.g. adherence, side effects) or related concerns. Pharmacists will document their interactions, assessments and recommendations for physicians using structured documentation forms. FPs will also receive aggregate-level comparative feedback six months later. Individual and aggregate session data and cardiovascular health resources will be available to participants and their FPs and pharmacists via a secure, password-protected website (see www.chapprogram.ca). The study is powered to detect a 21% reduction in the mean rate of hospital admission for acute myocardial infarction, congestive heart failure, and stroke (the composite primary end-point) for residents 65 years of age and older during the year following implementation of CHAP in program compared to control communities, using routinely-collected, population-based data held at the Institute for Clinical Evaluative Sciences (ICES). This trial is also being sponsored by: Elisabeth Bruyere Reserach Institute (EBRI) (Canada) c/o Larry W Chambers SCO Health Service 43 Bruyère Street Ottawa, Ontario K1N 5C8 Canada |
| Primary outcome measure(s) | The primary outcome measure will look at change in the composite outcome for one year prior to the program to one year following the program, in intervention compared to control communities, using administrative data. |
| Secondary outcome measure(s) |
Process data will inform evaluation of the success of community mobilisation and program delivery in the intervention communities.
Process measures in the program communities include: 1. Assessment of the success of community mobilisation 2. Surveys of volunteers, family physicians, and pharmacists 3. Interviews with coordinators 4. Final reports from lead organisations 5. Learning from a debriefing workshop with all program community partners This data is being collected during the six months following the ten-week program. |
| Sources of funding |
1. Canadian Stroke Network (CSN) (Canada)
2. Ministry of Health Promotion, Government of Ontario (Ontario Stroke System) (Canada) |
| Trial website | http://www.chapprogram.ca |
| Publications | 1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21300712 |
| Contact name | Dr Janusz Kaczorowski |
| Address |
Primary Care & Community Research at the Child & Family Research Institute
Suite 320, 5950 University Boulevard Department of Family Practice University of British Columbia |
| City/town | Vancouver |
| Zip/Postcode | V6T 1Z3 |
| Country | Canada |
| Sponsor | McMaster University (Canada) |
| Address |
c/o Janusz Kaczorowski
Department of Family Medicine 75 Frid Street Hamilton |
| City/town | Ontario |
| Zip/Postcode | L8P 4M3 |
| Country | Canada |
| Sponsor website: | http://www.mcmaster.ca/ |
| Date applied | 15/03/2007 |
| Last edited | 09/03/2011 |
| Date ISRCTN assigned | 09/05/2007 |
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| © 2012 ISRCTN unless otherwise stated. | |
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