NCT02842840

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
405

participants targeted

Target at P75+ for not_applicable stroke

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

April 12, 2016

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 25, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2017

Completed
Last Updated

July 26, 2016

Status Verified

July 1, 2016

Enrollment Period

1.5 years

First QC Date

April 12, 2016

Last Update Submit

July 23, 2016

Conditions

StrokeMedication AdherenceOlder Adults

Outcome Measures

Primary Outcomes (3)

  • 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

  • changes in blood pressure

    changes from baseline, 6 Months, 12 months and 18 months follow-up

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

    changes from baseline, 6 Months, 12 months and 18 months follow-up

Secondary Outcomes (7)

  • 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

  • Changes in Coping Plan

    changes from baseline, 6 Months, 12 months and 18 months follow-up

  • Changes in quality of life

    changes from baseline, 6 Months, 12 months and 18 months follow-up

  • Changes in perceived behavioral control to medication adherence

    changes from baseline, 6 Months, 12 months and 18 months follow-up

  • +2 more secondary outcomes

Study Arms (3)

Patients based intervention

EXPERIMENTAL

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

Family based intervention

EXPERIMENTAL

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

Behavioral: Family based intervention

Routine counseling

ACTIVE COMPARATOR

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

Interventions

Patient-based interventionBEHAVIORAL
Patients based intervention
Family based interventionBEHAVIORAL
Family based intervention
Routine counselingOTHER
Routine counseling

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • aged 65 years or older
  • able to give informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Department of Public Health, Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3419759811, Iran

RECRUITING

Qazvin University of Medical Sciences

Qazvin, Qazvin Province, 3419759811, Iran

RECRUITING

Outpatient Pediatric Clinic

Qazvin, Qazvin Province, Iran

RECRUITING

MeSH Terms

Conditions

StrokeMedication Adherence

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of health psychology

Study Record Dates

First Submitted

April 12, 2016

First Posted

July 25, 2016

Study Start

April 1, 2016

Primary Completion

October 1, 2017

Study Completion

November 1, 2017

Last Updated

July 26, 2016

Record last verified: 2016-07

Locations

IR(3)