Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
06-205
Study information
Scientific title
Acronym
C-CHAP
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.
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
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Quality of life
Patient information sheet
Condition
Cardiovascular disease risk factors
Intervention
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
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
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 measures
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.
Overall trial start date
01/03/2006
Overall trial end date
01/03/2009
Reason abandoned (if study stopped)
Eligibility
Participant 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.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
30% of seniors in program communities
Participant exclusion criteria
1. Communities of less than 10,000 residents
2. Fewer than five family physicians and two pharmacies in community
Recruitment start date
01/03/2006
Recruitment end date
01/03/2009
Locations
Countries of recruitment
Canada
Trial participating centre
Primary Care & Community Research at the Child & Family Research Institute
Vancouver
V6T 1Z3
Canada
Sponsor information
Organisation
McMaster University (Canada)
Sponsor details
c/o Janusz Kaczorowski
Department of Family Medicine
75 Frid Street
Hamilton
Ontario
L8P 4M3
Canada
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
Canadian Stroke Network (CSN) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Ministry of Health Promotion, Government of Ontario (Ontario Stroke System) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21300712
Publication citations
-
Results
Kaczorowski J, Chambers LW, Dolovich L, Paterson JM, Karwalajtys T, Gierman T, Farrell B, McDonough B, Thabane L, Tu K, Zagorski B, Goeree R, Levitt CA, Hogg W, Laryea S, Carter MA, Cross D, Sabaldt RJ, Improving cardiovascular health at population level: 39 community cluster randomised trial of Cardiovascular Health Awareness Program (CHAP)., BMJ, 2011, 342, d442.