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

Not Applicable

Completed

• Conditions: Depressive Disorder

• 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

Study Timeline

• Study First Submitted: 2018-07-09
• Study First Submitted QC: 2018-09-11
• Study First Posted: 2018-09-12
• Study Start: 2020-03-01
• Primary Completion: 2022-11-01
• Study Completion: 2022-11-01
• Status Verified: 2023-04
• Last Update Submitted: 2023-04-11
• Last Update Posted: 2023-04-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 170

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

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