Condition category
Circulatory System
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Dr Janusz Kaczorowski


Contact details

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

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title



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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Quality of life

Patient information sheet


Cardiovascular disease risk factors


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

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

Intervention type



Not Specified

Drug names

Primary outcome measures

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


Overall trial end date


Reason abandoned


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


Age group

Not Specified


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


Recruitment end date



Countries of recruitment


Trial participating centre

Primary Care & Community Research at the Child & Family Research Institute
V6T 1Z3

Sponsor information


McMaster University (Canada)

Sponsor details

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

Sponsor type




Funder type


Funder name

Canadian Stroke Network (CSN) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype


Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype


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

Results - basic reporting

Publication summary

1. 2011 results in

Publication citations

  1. 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.

Additional files

Editorial Notes