Clinical trial NCT02842840: The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients
Official title: The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Stroke
Medication Adherence
Older Adults
Lead sponsor: Qazvin University Of Medical Sciences
Sponsor class: OTHER
First posted: 2016-07-25
Enrollment: 405
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Stroke is a major cause of morbidity and mortality, especially in low and middle income countries including Iran. Patients with recent stroke or TIA are at high risk for new vascular events. Several evidence based strategies in secondary prevention of stroke are available but frequently underused. The study is aimed to evaluate an intervention to improve patients with Stroke.


Eligibility criteria: Inclusion Criteria:

* aged 65 years or older
* able to give informed consent

Exclusion Criteria:

* recurrent stroke
* a diagnosis of subarachnoid haemorrhage
* significant impairments precluding participation - inability to give informed consent
* another condition likely to impact their participation in the trial (e.g. life-threatening condition other than cardiovascular disease)
* expected discharge to hospital/nursing home setting

Primary outcomes:
measure: changes in Patient-reported Adherence Medication Adherence Rating Scale
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: changes in blood pressure
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: changes in low-density lipoprotein (LDL)-cholesterol level
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Secondary outcomes:
measure: Changes in intention to medication adherence
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Action Plan
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Coping Plan
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in quality of life
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in perceived behavioral control to medication adherence
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Self-monitoring to medication adherence
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
measure: Changes in Illness Perceptions
timeFrame: changes from baseline, 6 Months, 12 months and 18 months follow-up
Other outcomes:
Locations:
city: Qazvin
country: Iran, Islamic Republic of
facility: Department of Public Health, Qazvin University of Medical Sciences
city: Qazvin
country: Iran, Islamic Republic of
facility: Qazvin University of Medical Sciences
city: Qazvin
country: Iran, Islamic Republic of
facility: Outpatient Pediatric Clinic
Study officials:
References: