Community Cardiovascular Health Awareness Program

ISRCTN	ISRCTN50550004
DOI	https://doi.org/10.1186/ISRCTN50550004
Secondary identifying numbers	06-205

Submission date: 15/03/2007
Registration date: 09/05/2007
Last edited: 09/03/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Circulatory System

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Janusz Kaczorowski
Scientific

Primary Care & Community Research at the Child & Family Research Institute
Suite 320, 5950 University Boulevard
Department of Family Practice
University of British Columbia
Vancouver
V6T 1Z3
Canada

Study information

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
Study setting(s)	Not specified
Study type	Quality of life
Scientific title
Study acronym	C-CHAP
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
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 study start date	01/03/2006
Completion date	01/03/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target number of participants	30% of seniors in program communities
Key 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.
Key exclusion criteria	1. Communities of less than 10,000 residents 2. Fewer than five family physicians and two pharmacies in community
Date of first enrolment	01/03/2006
Date of final enrolment	01/03/2009

Locations

Countries of recruitment

Canada

Study participating centre

Primary Care & Community Research at the Child & Family Research Institute

Vancouver
V6T 1Z3
Canada

Sponsor information

McMaster University (Canada)
University/education

c/o Janusz Kaczorowski
Department of Family Medicine
75 Frid Street
Hamilton
Ontario
L8P 4M3
Canada

Website	http://www.mcmaster.ca/
"ROR"	https://ror.org/02fa3aq29

Funders

Funder type

Government

Canadian Stroke Network (CSN) (Canada)

No information available

Ministry of Health Promotion, Government of Ontario (Ontario Stroke System) (Canada)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	07/02/2011		Yes	No