A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
- Conditions
- Depressive Disorder
- Interventions
- Behavioral: Intervention to PsychiatristsBehavioral: Intervention to PatientsOther: Control
- Registration Number
- NCT03668457
- Lead Sponsor
- Servicio Canario de Salud
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 170
-
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:
• Patient:
- Patients with history of current bipolar disorder and/or any psychotic disorder
- Insufficient language skills
- Pregnancy
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- FACTORIAL
- Arm && Interventions
Group Intervention Description Intervention to Psychiatrists Intervention to Psychiatrists Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals Intervention to Patients Control Only patients receive intervention Control Control Psychiatrists provide the usual care Patients receive usual care Intervention to Patients Intervention to Patients Only patients receive intervention Mixed Intervention Control Patients and Psychiatrists associated with these patients receive intervention Mixed Intervention Intervention to Psychiatrists Patients and Psychiatrists associated with these patients receive intervention Intervention to Psychiatrists Control Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals Mixed Intervention Intervention to Patients Patients and Psychiatrists associated with these patients receive intervention
- Primary Outcome Measures
Name Time Method Change in the Sidorkiewicz instrument score 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 Outcome Measures
Name Time Method Change in the Sidorkiewicz instrument score Baseline, 3 and 12 months Change in adherence from baseline to 3 and 12 months.
Change in Hospital Anxiety and Depression Scale (HADS) score Baseline, 3, 6, and 12 months HADS contains two 7-item Likert scales, one for anxiety and one for depression, with responses being scored on a scale of 0-3 (3 indicates higher symptom frequencies).
Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36) Baseline, 6, and 12 months PF-10 contains 10-item Likert scale designed to examine a person's perceived limitation with physical functioning. Each item is rated on a 3-point scale (yes, limited a lot; yes, limited a little; and no, not limited at all).
Change in Beck Depression Inventory - II (BDI-II) score Baseline, 3, 6, and 12 months BDI-II contains 21 questions, each answer being scored on a scale value of 0 to 3. Higher total scores indicate more severe depressive symptoms.
Change in EQ-5D-5L Baseline, 6, and 12 months EQ-5D-5L is a questionnaire consisting of five domains (Mobility, Self-Care, Usual Activity, Pain/Discomfort and Anxiety/Depression) each with five levels (no problems, slight problems, moderate problems, severe problems and extreme problems).
Change in Patient-Practitioner Orientation Scale (PPOS) score Baseline and 12 months PPOS is a self-administered questionnaire that assesses patient-centeredness healthcare professionals. PPOS contains 18 items scored on a 6-point Likert scale (strongly disagree to strongly agree).
Trial Locations
- Locations (1)
Servicio de Evaluación. Servicio Canario de Salud
🇪🇸Santa Cruz de Tenerife, Spain