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

Recruiting

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Patient-based intervention Behavioral
    ARM 1: Kind: Experimental
    Label: Patients based intervention
    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.
  • Family based intervention Behavioral
    ARM 1: Kind: Experimental
    Label: Family based intervention
    Description: Patients and their families will receive a series of educational/motivational interventions.
  • Routine counseling Other
    ARM 1: Kind: Experimental
    Label: Routine counseling
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Intervention: Parallel Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary changes in Patient-reported Adherence Medication Adherence Rating Scale changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Primary changes in blood pressure changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Primary changes in low-density lipoprotein (LDL)-cholesterol level changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in intention to medication adherence changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in Action Plan changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in Coping Plan changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in quality of life changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in perceived behavioral control to medication adherence changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in Self-monitoring to medication adherence changes from baseline, 6 Months, 12 months and 18 months follow-up Yes
Secondary Changes in Illness Perceptions changes from baseline, 6 Months, 12 months and 18 months follow-up Yes

Sponsors