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

Stroke Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02842840
• Other study ID #: IR.QUMS.REC.1394.350
• Status: Recruiting
• Phase: N/A
• First received: April 12, 2016
• Last updated: July 23, 2016
• Start date: April 2016
• Est. completion date: November 2017

Study information

• Verified date: July 2016
• Source: Qazvin University Of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Iran: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 405
• Est. completion date: November 2017
• Est. primary completion date: October 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Medication Adherence
• Older Adults
• Stroke

Intervention

Behavioral:
• Patient-based intervention

• Family based intervention

Other:
• Routine counseling

Locations

Country	Name	City	State
Iran, Islamic Republic of	Department of Public Health, Qazvin University of Medical Sciences	Qazvin
Iran, Islamic Republic of	Outpatient Pediatric Clinic	Qazvin
Iran, Islamic Republic of	Qazvin University of Medical Sciences	Qazvin

Sponsors (1)

Lead Sponsor	Collaborator
Qazvin University Of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Primary	changes in blood pressure		changes from baseline, 6 Months, 12 months and 18 months follow-up	Yes
Primary	changes in low-density lipoprotein (LDL)-cholesterol level		changes from baseline, 6 Months, 12 months and 18 months follow-up	Yes
Secondary	Changes in intention to medication adherence		changes from baseline, 6 Months, 12 months and 18 months follow-up	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes