The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Stroke, Medication Adherence, Older Adults

Intervention / Treatment
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* Behavioral: Patient-based intervention
* Behavioral: Family based intervention
* Other: Routine counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients based intervention<br>A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients. | Behavioral: Patient-based intervention<br> <br> |
| Experimental: Family based intervention<br>Patients and their families will receive a series of educational/motivational interventions. | Behavioral: Family based intervention<br> <br> |
| Active Comparator: Routine counseling<br>All participants of the study in both group receive the Standard Care. Usually, patients in clinics receive a one-time session of brief advice to use medications regularly lasting approximately 30 minutes and deliver by nurse or physician. Some issues rise in this short session including coexisting diseases, the history of drug use, current disease and advice about the health risks of irregular medication use. | Other: Routine counseling<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Patient-reported Adherence Medication Adherence Rating Scale | a self-report measure of adherence (Medication Adherence Report Scale [MARS-5]) will be used . | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| changes in blood pressure |  | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| changes in low-density lipoprotein (LDL)-cholesterol level |  | changes from baseline, 6 Months, 12 months and 18 months follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in intention to medication adherence |  | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in Action Plan | The action plan is assessed by a self-reported questionnaire. it is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in Coping Plan | The coping plan is assessed by a self-reported questionnaire. It is used by the patients before, at baseline, six months, twelve months and eighteen months after the intervention | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in quality of life | The Short Form (36) Health Survey is used to assess patient's quality of life | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in perceived behavioral control to medication adherence | The perceived behavioral control to medication adherence is assessed through a self-report instrument | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in Self-monitoring to medication adherence | The Self-monitoring to medication adherence is assessed through a self-report instrument | changes from baseline, 6 Months, 12 months and 18 months follow-up | 
| Changes in Illness Perceptions | the Brief Illness Perception. Questionnaire (Brief IPQ) is used to assess patient's illness representation | changes from baseline, 6 Months, 12 months and 18 months follow-up |