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

Primary Purpose

Stroke, Medication Adherence, Older Adults

Status

Unknown status

Phase

Not Applicable

Locations

Iran, Islamic Republic of

Study Type

Interventional

Intervention

Patient-based intervention

Family based intervention

Routine counseling

About this trial

This is an interventional prevention trial for Stroke

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Department of Public Health, Qazvin University of Medical SciencesRecruiting
Qazvin University of Medical SciencesRecruiting
Outpatient Pediatric ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Patients based intervention

Family based intervention

Routine counseling

Arm Description

A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients.

Patients and their families will receive a series of educational/motivational interventions.

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.

Outcomes

Primary Outcome Measures

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 in blood pressure

changes in low-density lipoprotein (LDL)-cholesterol level

Secondary Outcome Measures

Changes in intention to medication adherence

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 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 in quality of life

The Short Form (36) Health Survey is used to assess patient's quality of life

Changes in perceived behavioral control to medication adherence

The perceived behavioral control to medication adherence is assessed through a self-report instrument

Changes in Self-monitoring to medication adherence

The Self-monitoring to medication adherence is assessed through a self-report instrument

Changes in Illness Perceptions

the Brief Illness Perception. Questionnaire (Brief IPQ) is used to assess patient's illness representation

Full Information

NCT ID

NCT02842840

First Posted

April 12, 2016

Last Updated

July 23, 2016

Sponsor

Qazvin University Of Medical Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02842840

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2016

Overall Recruitment Status

Unknown status

Study Start Date

April 2016 (undefined)

Primary Completion Date

October 2017 (Anticipated)

Study Completion Date

November 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Qazvin University Of Medical Sciences

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stroke, Medication Adherence, Older Adults

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

405 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Patients based intervention

Arm Type

Experimental

Arm Description

A multifaceted intervention program will use to improve adherence and clinical outcomes in Stroke patients. This intervention focus on behavioral treatment in the patients.

Arm Title

Family based intervention

Arm Type

Experimental

Arm Description

Patients and their families will receive a series of educational/motivational interventions.

Arm Title

Routine counseling

Arm Type

Active Comparator

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Patient-based intervention

Intervention Type

Behavioral

Intervention Name(s)

Family based intervention

Intervention Type

Other

Intervention Name(s)

Routine counseling

Primary Outcome Measure Information:

Title

changes in Patient-reported Adherence Medication Adherence Rating Scale

Description

a self-report measure of adherence (Medication Adherence Report Scale [MARS-5]) will be used .

Time Frame