A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders

Servicio Canario de Salud170 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

SINGLE

Enrollment

170

Conditions

Depressive Disorder

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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: • Patient: * Patients with history of current bipolar disorder and/or any psychotic disorder * Insufficient language skills * Pregnancy

Outcomes

Primary Outcomes

Change in the Sidorkiewicz instrument score

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).

Time frame: Baseline and 6 months

Secondary Outcomes

Change in the Sidorkiewicz instrument score

Change in adherence from baseline to 3 and 12 months.

Time frame: Baseline, 3 and 12 months

Change in Beck Depression Inventory - II (BDI-II) score

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.

Time frame: Baseline, 3, 6, and 12 months

Change in Hospital Anxiety and Depression Scale (HADS) score

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).

Time frame: Baseline, 3, 6, and 12 months

Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36)

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).

Time frame: Baseline, 6, and 12 months

Change in EQ-5D-5L

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).

Time frame: Baseline, 6, and 12 months

Change in Patient-Practitioner Orientation Scale (PPOS) score

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).

Time frame: Baseline and 12 months