Effectiveness and Cost-effectiveness of a Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Depressive Disorder
- Sponsor
- Servicio Canario de Salud
- Enrollment
- 170
- Locations
- 1
- Primary Endpoint
- Change in the Sidorkiewicz instrument score
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
Objective: The study of medication adherence in depression (MAPDep study) aims to evaluate the effectiveness and cost-effectiveness of a multi-component strategy to enhance patient-centered care to improve adherence toward medications in patients with depression, formed by an educational intervention to psychiatrists and/or a collaborative care intervention group to patients and relatives plus a reminder system through the use of a mobile APP.
Methods: The objective will be assessed under an open multicenter, clinical controlled trial with random allocation by clusters to one of three interventions or to usual care (control arm). In group 1 only patients and family members receive intervention, in group 2 only psychiatrists receive intervention, and group 3 is a combined intervention for patients and psychiatrists. The main measure will be the change in medication adherence rate. Secondary endpoints are depression, emotional distress, health-related quality of life, physical functioning, patients' knowledge about their medications, provider beliefs regarding patient-centeredness, and healthcare resource utilization.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients:
- •Patients with diagnosis of depressive disorder (major depressive disorder MDD and/or dysthymia) under pharmacological treatment
- •Regular users of mobile phones
- •Patients who have consulted their psychiatrist about their depression at least once in the previous 6 months
- •Health professionals:
- •Psychiatrists have no intention of moving from their practice during the study period.
- •Exclusion criteria:
- •Patients with history of current bipolar disorder and/or any psychotic disorder
- •Insufficient language skills
- •Pregnancy
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Change in the Sidorkiewicz instrument score
Time Frame: Baseline and 6 months
Change in adherence from baseline to 6 months. This instrument contains 5 questions to help patients recognize their different medication-taking behaviors for each drug taken. The results generate adherence levels ranging from 1 (high drug adherence) to 6 (drug discontinuation).
Secondary Outcomes
- Change in the Sidorkiewicz instrument score(Baseline, 3 and 12 months)
- Change in Hospital Anxiety and Depression Scale (HADS) score(Baseline, 3, 6, and 12 months)
- Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36)(Baseline, 6, and 12 months)
- Change in Beck Depression Inventory - II (BDI-II) score(Baseline, 3, 6, and 12 months)
- Change in EQ-5D-5L(Baseline, 6, and 12 months)
- Change in Patient-Practitioner Orientation Scale (PPOS) score(Baseline and 12 months)