ISRCTN ISRCTN61739603
DOI https://doi.org/10.1186/ISRCTN61739603
Protocol serial number N/A
Sponsor Biovail Pharmaceuticals Canada, formerly Crystaal Corporation
Funder Biovail Corporation Canada, formerly Crystaal Corporation
Submission date
27/05/2005
Registration date
01/06/2005
Last edited
15/04/2008
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

Contact information

Dr Janusz Kaczorowski
Scientific

1200 Main Street West HSC-2V12
Hamilton
L8N 3Z5
Canada

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designSingle-centre
Scientific title
Study acronymSHINE - Dundas Pilot
Study objectivesTo determine the best method (mail or telephone) for
family physicians’ offices to invite patients to attend a session, and to identify factors that predicted attendance. In preparation for a larger scale randomized controlled trial, we also performed a cost analysis of invitation method and success rate, investigated the operational and methodological aspects of the proposed intervention, and queried patients’ willingness to continue to attend community pharmacy blood pressure sessions and their preferences for the time and frequency of the sessions.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedHypertension
InterventionRegular patients 65 years or older (n = 235) were
randomly allocated to invitation by mail or telephone to attend pharmacy cardiovascular health
awareness sessions led by volunteer peer health educators.
Intervention typeOther
Primary outcome measure(s)

The primary end-point
was the overall attendance among patients invited by mail compared to those invited by telephone.

Key secondary outcome measure(s)

Not provided at time of registration

Completion date27/04/2001

Eligibility

Participant type(s)Patient
Age groupSenior
SexAll
Target sample size at registration235
Key inclusion criteriaPatients were eligible to participate if they were 65
years of age or older, considered by the physician to be regular patients, community dwelling, and able to attend a cardiovascular health promotion session in a local pharmacy.
Key exclusion criteriaPatients were excluded if
they suffered from dementia or a serious, non-cardiovascular disease or condition, or were non-English
speaking and could not attend with an English-speaking companion.
Date of first enrolment01/03/2001
Date of final enrolment27/04/2001

Locations

Countries of recruitment

  • Canada

Study participating centre

1200 Main Street West HSC-2V12
Hamilton
L8N 3Z5
Canada

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 19/08/2005 Yes No