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

Not Applicable

• Conditions: Medication Adherence; Stroke; Older Adults
• Interventions: Behavioral: Family based intervention; Behavioral: Patient-based intervention; Other: Routine counseling

• Registration Number: NCT02842840
• Lead Sponsor: Qazvin University Of Medical Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-04-12
• Status Verified: 2016-07
• Study First Submitted QC: 2016-07-20
• Last Update Submitted: 2016-07-23
• Study First Posted: 2016-07-25
• Last Update Posted: 2016-07-26
• Primary Completion: 2017-10
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 405

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Family based intervention	Family based intervention	Patients and their families will receive a series of educational/motivational interventions.
Patients based intervention	Patient-based intervention	A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients.
Routine counseling	Routine counseling	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.

Primary Outcome Measures

Name	Time	Method
changes in low-density lipoprotein (LDL)-cholesterol level	changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in Patient-reported Adherence Medication Adherence Rating Scale	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	changes from baseline, 6 Months, 12 months and 18 months follow-up

Secondary Outcome Measures

Name	Time	Method
Changes in Coping Plan	changes from baseline, 6 Months, 12 months and 18 months follow-up	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 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	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 in quality of life	changes from baseline, 6 Months, 12 months and 18 months follow-up	The Short Form (36) Health Survey is used to assess patient's quality of life
Changes in perceived behavioral control to medication adherence	changes from baseline, 6 Months, 12 months and 18 months follow-up	The perceived behavioral control to medication adherence is assessed through a self-report instrument
Changes in Self-monitoring to medication adherence	changes from baseline, 6 Months, 12 months and 18 months follow-up	The Self-monitoring to medication adherence is assessed through a self-report instrument
Changes in Illness Perceptions	changes from baseline, 6 Months, 12 months and 18 months follow-up	the Brief Illness Perception. Questionnaire (Brief IPQ) is used to assess patient's illness representation

Trial Locations

Locations (3)

Qazvin University of Medical Sciences; 🇮🇷 Qazvin, Iran, Islamic Republic of

Outpatient Pediatric Clinic; 🇮🇷 Qazvin, Iran, Islamic Republic of

Department of Public Health, Qazvin University of Medical Sciences; 🇮🇷 Qazvin, Iran, Islamic Republic of