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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
405

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 12, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 20, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 25, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 23, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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