Condition category
Circulatory System
Date applied
03/03/2009
Date assigned
09/03/2009
Last edited
24/09/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Richard Chan

ORCID ID

http://orcid.org/0000-0002-8302-6606

Contact details

339 Windermere Rd.
Rm B10-118
University Hospital
London
N6A 5A5
Canada

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

MCT-91025

Study information

Scientific title

Promoting adherence to a regimen of risk factor modification by trained non-medical personnel evaluated against regular practice: a open-label randomised controlled trial

Acronym

PARTNERS

Study hypothesis

The study will examine the efficacy, durability, and cost-effectiveness of the volunteer-facilitated risk factor modification program, compared against regular practice in patients who have experienced recent ischaemic cerebrovascular events.

24/09/2015: Updated overall trial end date from 01/10/2013 to 30/09/2017 and recruitment end date from 01/10/2013 to 31/07/2014.

Ethics approval

University of Western Ontario Health Research Ethics Board gave approval on the 15th January 2009 (ref: 15516)

Study design

Open-label blinded-adjudication randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Stroke/transient ischaemic attack (TIA)

Intervention

This is an open-label randomised controlled trial with equal number of subjects in both arms:
1. Regular practice (RP)
2. Regular practice plus volunteer-facilitated risk factor modification program (RV)

The RP arm will serve as the control group; subjects in this group will receive standard medical care. Subjects in the RV group will receive standard medical care and scheduled contact with a trained volunteer. The volunteers will serve as health information providers, lifestyle coaches, and peer supporters.

Total duration of both arms of the study is 2 years. For patients in the intervention group the volunteer phone contacts will occur over the first year. There will be a total of 10 contacts, one of which will be a face to face meeting at the outset to allow the volunteer and participant to meet. The telephone contacts will follow a script and time will depend on the participant. If there are no concerns or questions the call would generally take about 20 minutes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Difference between the 12-month and the baseline systolic blood pressure (SBP).

Secondary outcome measures

Efficacy outcome measures:
The difference between the 12-month and baseline values of the following:
1. Diastolic blood pressure (DBP)
2. Medication adherence rate
3. Body mass index
4. Cardiovascular risk score
5. Waist circumference
6. Low density lipoprotein cholesterol (LDL-C) concentration
7. Total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio
8. HbA1c level
9. Cigarette smoking status
10. Alcohol consumption rate
11. Level of physical activities
12. Quality of life (SF-36)
13. Cognitive tests scores

The differences between the 24-month and baseline values of these same factors, plus the difference between the 24-month and baseline SBP, constitute the durability outcome measures

Other outcome measures:
14. Clinical outcome event (stroke, myocardial infarction [MI], all-cause death)
15. Estimated total healthcare expenditure

Overall trial start date

01/04/2009

Overall trial end date

30/09/2017

Reason abandoned

Eligibility

Participant inclusion criteria

Subjects aged 18 years or greater, either sex, who:
1. Experienced transient ischaemic attack or non-disabling stroke within 90 days of randomisation
2. Have hypertension

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

316

Participant exclusion criteria

1. Neuroimaging studies suggest other causes for presenting event (e.g., primary intracerebral haemorrhage, tumour, etc.)
2. Unable to communicate in English or French, or severe aphasia
3. Moderate to severe disability with modified Rankin Scale score greater than or equal to 3
4. Known dementia
5. Severe concomitant medical conditions with life expectancy of less than two years
6. Unable or unwilling to return for study-related scheduled follow-ups
7. Concurrent participation in other interventional studies

Recruitment start date

01/04/2009

Recruitment end date

31/07/2014

Locations

Countries of recruitment

Canada

Trial participating centre

339 Windermere Rd., Rm B10-118
London
N6A 5A5
Canada

Sponsor information

Organisation

London Health Sciences Centre (Canada)

Sponsor details

339 Windermere Road
London
Ontario
N6A 5A5
Canada

Sponsor type

Hospital/treatment centre

Website

http://www.lhsc.on.ca

Funders

Funder type

Research organisation

Funder name

Canadian Stroke Network (CSN) (Canada)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-91025)

Alternative name(s)

Instituts de Recherche en Santé du Canada, CIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

Canada

Results and Publications

Publication and dissemination plan

Publication in a peer reviewed journal.

Intention to publish date

01/07/2016

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes