Condition category
Circulatory System
Date applied
27/05/2005
Date assigned
01/06/2005
Last edited
15/04/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Janusz Kaczorowski

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

SHINE - Dundas Pilot

Study hypothesis

To 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

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Single-centre

Trial setting

GP practices

Trial type

Diagnostic

Patient information sheet

Condition

Hypertension

Intervention

Regular 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 type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/03/2001

Overall trial end date

27/04/2001

Reason abandoned

Eligibility

Participant inclusion criteria

Patients 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.

Participant type

Patient

Age group

Senior

Gender

Both

Target number of participants

235

Participant exclusion criteria

Patients 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.

Recruitment start date

01/03/2001

Recruitment end date

27/04/2001

Locations

Countries of recruitment

Canada

Trial participating centre

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

Sponsor information

Organisation

Biovail Pharmaceuticals Canada, formerly Crystaal Corporation

Sponsor details

7150 Mississauga Road
Mississauga
Ontario
L5N 8M5
Canada

Sponsor type

Industry

Website

Funders

Funder type

Industry

Funder name

Biovail Corporation Canada, formerly Crystaal Corporation

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

Results - basic reporting

Publication summary

Results: http://www.ncbi.nlm.nih.gov/pubmed/16111487

Publication citations

  1. Results

    Karwalajtys T, Kaczorowski J, Chambers LW, Levitt C, Dolovich L, McDonough B, Patterson C, Williams JE, A randomized trial of mail vs. telephone invitation to a community-based cardiovascular health awareness program for older family practice patients [ISRCTN61739603]., BMC Fam Pract, 2005, 6, 35, doi: 10.1186/1471-2296-6-35.

Additional files

Editorial Notes