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Clinical Trials/NCT02842840
NCT02842840
Unknown
N/A

The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial

Qazvin University Of Medical Sciences3 sites in 1 country405 target enrollmentApril 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Stroke
Sponsor
Qazvin University Of Medical Sciences
Enrollment
405
Locations
3
Primary Endpoint
changes in low-density lipoprotein (LDL)-cholesterol level
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2016
End Date
November 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Amir H Pakpour

Associate Professor of health psychology

Qazvin University Of Medical Sciences

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

Outcomes

Primary Outcomes

changes in low-density lipoprotein (LDL)-cholesterol level

Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

changes in Patient-reported Adherence Medication Adherence Rating Scale

Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

a self-report measure of adherence (Medication Adherence Report Scale \[MARS-5\]) will be used .

changes in blood pressure

Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up

Secondary Outcomes

  • Changes in Self-monitoring to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in Illness Perceptions(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in intention to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in Action Plan(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in Coping Plan(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in quality of life(changes from baseline, 6 Months, 12 months and 18 months follow-up)
  • Changes in perceived behavioral control to medication adherence(changes from baseline, 6 Months, 12 months and 18 months follow-up)

Study Sites (3)

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