Promoting Adherence to a Regimen of risk factor modification by Trained Non-medical personnel Evaluated against Regular practice Study

ISRCTN	ISRCTN07607027
DOI	https://doi.org/10.1186/ISRCTN07607027
Protocol serial number	MCT-91025
Sponsor	London Health Sciences Centre (Canada)
Funders	Canadian Stroke Network (CSN) (Canada), Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-91025)

Submission date: 03/03/2009
Registration date: 09/03/2009
Last edited: 24/09/2015

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Richard Chan
Scientific

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

ORCID ID	0000-0002-8302-6606

Study information

Primary study design	Interventional
Study design	Open-label blinded-adjudication randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
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
Study acronym	PARTNERS
Study objectives	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(s)	University of Western Ontario Health Research Ethics Board gave approval on the 15th January 2009 (ref: 15516)
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Difference between the 12-month and the baseline systolic blood pressure (SBP).
Key secondary outcome measure(s)	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
Completion date	30/09/2017

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	316
Key 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
Key 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
Date of first enrolment	01/04/2009
Date of final enrolment	31/07/2014

Locations

Countries of recruitment

Canada

Study participating centre

339 Windermere Rd., Rm B10-118

London
N6A 5A5
Canada

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes