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17 May 2012
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| [ ...Back to search results ] | [ Print-friendly version ] |
| Promoting Adherence to a Regimen of risk factor modification by Trained Non-medical personnel Evaluated against Regular practice Study |
| ISRCTN | ISRCTN07607027 |
| ClinicalTrials.gov identifier | |
| Public title | Promoting Adherence to a Regimen of risk factor modification by Trained Non-medical personnel Evaluated against Regular practice Study |
| 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 |
| Serial number at source | MCT-91025 |
| 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. |
| Lay summary | |
| 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 |
| Countries of recruitment | Canada |
| Disease/condition/study domain | Stroke/transient ischaemic attack (TIA) |
| Participants - 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 |
| Participants - 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 |
| Anticipated start date | 01/04/2009 |
| Anticipated end date | 01/10/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Target number of participants | 844 |
| Interventions |
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. |
| Primary outcome measure(s) | Difference between the 12-month and the baseline systolic blood pressure (SBP). |
| 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 |
| Sources of funding |
1. Canadian Stroke Network (CSN) (Canada)
2. Canadian Institutes of Health Research (CIHR) (Canada) (ref: MCT-91025) |
| Trial website | |
| Publications | |
| Contact name | Dr Richard Chan |
| Address |
339 Windermere Rd., Rm B10-118
University Hospital |
| City/town | London |
| Zip/Postcode | N6A 5A5 |
| Country | Canada |
| Sponsor | London Health Sciences Centre (Canada) |
| Address | 339 Windermere Road |
| City/town | London, Ontario |
| Zip/Postcode | N6A 5A5 |
| Country | Canada |
| Sponsor website: | http://www.lhsc.on.ca |
| Date applied | 03/03/2009 |
| Last edited | 09/03/2009 |
| Date ISRCTN assigned | 09/03/2009 |
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