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
Secondary identifying numbers 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

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 logo 0000-0002-8302-6606

Study information

Study designOpen-label blinded-adjudication randomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titlePromoting adherence to a regimen of risk factor modification by trained non-medical personnel evaluated against regular practice: a open-label randomised controlled trial
Study acronymPARTNERS
Study hypothesisThe 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)
ConditionStroke/transient ischaemic attack (TIA)
InterventionThis 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 typeOther
Primary outcome measureDifference between the 12-month and the baseline systolic blood pressure (SBP).
Secondary outcome measuresEfficacy 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 study start date01/04/2009
Overall study end date30/09/2017

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participants316
Participant inclusion criteriaSubjects 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 exclusion criteria1. 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 date01/04/2009
Recruitment end date31/07/2014

Locations

Countries of recruitment

  • Canada

Study participating centre

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

Sponsor information

London Health Sciences Centre (Canada)
Hospital/treatment centre

339 Windermere Road
London, Ontario
N6A 5A5
Canada

http://www.lhsc.on.ca
ROR logo https://ror.org/037tz0e16

Funders

Funder type

Research organisation

Canadian Stroke Network (CSN) (Canada)

No information available

Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-91025)
Government organisation / National government
Alternative name(s)
Instituts de Recherche en Santé du Canada, Canadian Institutes of Health Research (CIHR), CIHR_IRSC, Canadian Institutes of Health Research | Ottawa ON, CIHR, IRSC
Location
Canada

Results and Publications

Intention to publish date01/07/2016
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planPublication in a peer reviewed journal.
IPD sharing plan
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