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

July 23, 2016 updated by: Amir H Pakpour, Qazvin University Of Medical Sciences

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

405

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Iran, Islamic Republic of
      • Qazvin, Iran, Islamic Republic of, 3419759811
        • Recruiting
        • Department of Public Health, Qazvin University of Medical Sciences
        • Contact:
        • Principal Investigator:
          • Amir H Pakpour, Ph.D.
      • Qazvin, Iran, Islamic Republic of, 3419759811
        • Recruiting
        • Qazvin University of Medical Sciences
        • Contact:
      • Qazvin, Iran, Islamic Republic of
        • Recruiting
        • Outpatient Pediatric Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Patients 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.
Behavioral: Patient-based intervention
Experimental: Family based intervention
Patients and their families will receive a series of educational/motivational interventions.
Behavioral: Family based intervention
Active Comparator: 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.
Other: Routine counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 from baseline, 6 Months, 12 months and 18 months follow-up
changes in blood pressure
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
changes in low-density lipoprotein (LDL)-cholesterol level
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
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
Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up
changes from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Action Plan
Time Frame: 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 from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Coping Plan
Time Frame: 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 from baseline, 6 Months, 12 months and 18 months follow-up
Changes in quality of life
Time Frame: 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 from baseline, 6 Months, 12 months and 18 months follow-up
Changes in perceived behavioral control to medication adherence
Time Frame: 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 from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Self-monitoring to medication adherence
Time Frame: 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 from baseline, 6 Months, 12 months and 18 months follow-up
Changes in Illness Perceptions
Time Frame: 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
changes from baseline, 6 Months, 12 months and 18 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qazvin University Of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

November 1, 2017

Study Registration Dates

First Submitted

April 12, 2016

First Submitted That Met QC Criteria

July 20, 2016

First Posted (Estimate)

July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

July 26, 2016

Last Update Submitted That Met QC Criteria

July 23, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IR.QUMS.REC.1394.350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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