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

Not Applicable

Completed

• Conditions: Stroke/transient ischaemic attack (TIA); Circulatory System; Other cerebrovascular diseases

• Registration Number: ISRCTN07607027
• Lead Sponsor: ondon Health Sciences Centre (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03-09
• Last Update Posted: 17 October 2016

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 316

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Efficacy outcome measures:<br>The difference between the 12-month and baseline values of the following:<br>1. Diastolic blood pressure (DBP)<br>2. Medication adherence rate<br>3. Body mass index <br>4. Cardiovascular risk score<br>5. Waist circumference<br>6. Low density lipoprotein cholesterol (LDL-C) concentration<br>7. Total cholesterol/high density lipoprotein cholesterol (HDL-C) ratio<br>8. HbA1c level<br>9. Cigarette smoking status<br>10. Alcohol consumption rate<br>11. Level of physical activities<br>12. Quality of life (SF-36)<br>13. Cognitive tests scores<br><br>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<br><br>Other outcome measures:<br>14. Clinical outcome event (stroke, myocardial infarction [MI], all-cause death)<br>15. Estimated total healthcare expenditure