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

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ClinicalTrials.gov Identifier: NCT02842840
Recruitment Status : Unknown
Verified July 2016 by Amir H Pakpour, Qazvin University Of Medical Sciences.
Recruitment status was:  Recruiting
First Posted : July 25, 2016
Last Update Posted : July 26, 2016
Sponsor:
Information provided by (Responsible Party):
Amir H Pakpour, Qazvin University Of Medical Sciences

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.

Condition or disease Intervention/treatment Phase
Stroke Medication Adherence Older Adults Behavioral: Patient-based intervention Behavioral: Family based intervention Other: Routine counseling Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 405 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: The Effectiveness of Multimodal Educational Intervention to Improve Adherence to Treatment Regimens in Older Stroke Patients: A Randomised Trial
Study Start Date : April 2016
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : November 2017

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



Primary Outcome Measures :
  1. 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 .

  2. changes in blood pressure [ Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up ]
  3. changes in low-density lipoprotein (LDL)-cholesterol level [ Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up ]

Secondary Outcome Measures :
  1. Changes in intention to medication adherence [ Time Frame: changes from baseline, 6 Months, 12 months and 18 months follow-up ]
  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02842840


Locations
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Iran, Islamic Republic of
Department of Public Health, Qazvin University of Medical Sciences Recruiting
Qazvin, Iran, Islamic Republic of, 3419759811
Contact: Amir Pakpour, Ph.D.    982813338127    amir.pakpour@gmail.com   
Principal Investigator: Amir H Pakpour, Ph.D.         
Qazvin University of Medical Sciences Recruiting
Qazvin, Iran, Islamic Republic of, 3419759811
Contact: Amir H Pakpour, PhD    982813338127    Pakpour_Amir@yahoo.com   
Outpatient Pediatric Clinic Recruiting
Qazvin, Iran, Islamic Republic of
Contact: Amir H Pakpour, PhD    982813338127    amir.pakpour@gmail.com   
Sponsors and Collaborators
Qazvin University Of Medical Sciences
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Responsible Party: Amir H Pakpour, Associate Professor of health psychology, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT02842840    
Other Study ID Numbers: IR.QUMS.REC.1394.350
First Posted: July 25, 2016    Key Record Dates
Last Update Posted: July 26, 2016
Last Verified: July 2016
Additional relevant MeSH terms:
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Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases