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

Effectiveness and Cost-effectiveness of a Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders

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 Overview

• Status: Completed
• Conditions: Depressive Disorder
• Intervention / Treatment: Behavioral: Intervention to Patients; Other: Control; Behavioral: Intervention to Psychiatrists

• Study Type: Interventional
• Enrollment (Actual): 170
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Santa Cruz de Tenerife, Spain, 38004
    • Servicio de Evaluación. Servicio Canario de Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention to Patients; Only patients receive intervention	Behavioral: Intervention to Patients; Multifaceted intervention consisting of: A collaborative care management intervention, including depression education, medication management and behavioral activation.; Use of a medication reminder mobile app.; Other: Control; Other: Usual care Usual care for depressive disorder received in mental health units
Experimental: Intervention to Psychiatrists; Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals	Other: Control; Other: Usual care Usual care for depressive disorder received in mental health units; Behavioral: Intervention to Psychiatrists; Educational intervention consisting of theoretical and practical sessions to to improve communication and negotiation abilities, and to develop skills to promote patient-centered care and shared decision-making.
Experimental: Mixed Intervention; Patients and Psychiatrists associated with these patients receive intervention	Behavioral: Intervention to Patients; Multifaceted intervention consisting of: A collaborative care management intervention, including depression education, medication management and behavioral activation.; Use of a medication reminder mobile app.; Other: Control; Other: Usual care Usual care for depressive disorder received in mental health units; Behavioral: Intervention to Psychiatrists; Educational intervention consisting of theoretical and practical sessions to to improve communication and negotiation abilities, and to develop skills to promote patient-centered care and shared decision-making.
Other: Control; Psychiatrists provide the usual care Patients receive usual care	Other: Control; Other: Usual care Usual care for depressive disorder received in mental health units

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Baseline and 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the Sidorkiewicz instrument score	Change in adherence from baseline to 3 and 12 months.	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.	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).	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).	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).	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).	Baseline and 12 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Healthcare utilization, cost and productivity losses	Costs because of the clinical management in all groups will be assessed from the healthcare services perspective, including the costs related to the development and use of all components for each intervention assessed (group sessions, app, etc.). Information about prescribed medication and doses; patient contacts with psychiatric and primary care services; hospital admissions and length of stay; and productivity losses will be obtained from a self-administered questionnaire.	Baseline, 6, and 12 months
The Control Preferences Scale (CPS)	CPS consists of five "cards" on a board, each illustrating a different role in decision-making by means of a cartoon and short descriptive statement. Patients has to choose between the cards, observing them one at a time, to establish an order of preference that ranged from a completely active role to a more passive style (from 0 to 5, where the higher the score, the more passive the style).	Baseline
Drug Attitude Inventory (DAI)	DAI is 10-item self-report scale that assesses psychiatric patients' attitudes toward their psychopharmacological medications. Response options are true/false, with scores ranging from a minimum of -10 to a maximum of 10. A positive total score means a positive attitude, while a negative total score indicates a negative attitude.	Baseline
Form C of the Multidimensional Health Locus of Control Scales (MHLC-C)	MHLC-C is an 18-item self-report scale composed of four subscales that measure control variables with regard to participants' health, with a 6-point rating scale ranging from 1 (strongly disagree) to 6 (strongly agree). Higher scores on each subscale indicate a stronger belief in that kind of control.	Baseline
The Hong Psychological Reactance Scale (HPRS)	HPRS is a 14-item self-report questionnaire designed to measure the individual difference in reactance proneness. Each item is rated on a five-point Likert scale (ranging from 1 = strongly disagree to 5 = strongly agree).	Baseline
Beliefs about Medicines Questionnaire (BMQ)	BMQ assesses patients' beliefs and worries about taking medication for their disease. It comprises a general and a specific scale.The BMQ-General scale assesses more general beliefs or social representations of pharmaceuticals as a class of treatment and includes eight items in two subscales (four items each), Overuse and Harm. The BMQ-Specific scale assesses patient's beliefs about the medication he/she is prescribed for a specific illness in terms of the necessity and concern about taking it. This scale includes ten items in two subscales (five items each), Concern and Necessity. The degree of agreement with each statement is indicated on a five-point Likert scale (ranging from 1=strongly disagree to 5=strongly agree).	Baseline

Collaborators and Investigators

• Sponsor: Servicio Canario de Salud
• Collaborators: University of La Laguna

Publications and helpful links

General Publications

• Del Pino-Sedeno T, Penate W, de Las Cuevas C, Valcarcel-Nazco C, Fumero A, Serrano-Perez PG, Acosta Artiles FJ, Ramos Garcia V, Leon Salas B, Bejarano-Quisoboni D, Trujillo-Martin MM. Effectiveness and cost-effectiveness of a multicomponent intervention to improve medication adherence in people with depressive disorders - MAPDep: a study protocol for a cluster randomized controlled trial. Patient Prefer Adherence. 2019 Feb 22;13:309-319. doi: 10.2147/PPA.S172963. eCollection 2019.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): November 1, 2022

Study Registration Dates

• First Submitted: July 9, 2018
• First Submitted That Met QC Criteria: September 11, 2018
• First Posted (Actual): September 12, 2018

Study Record Updates

• Last Update Posted (Actual): April 12, 2023
• Last Update Submitted That Met QC Criteria: April 11, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Depression; Medication adherence; Multicomponent intervention
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: PI18-00767

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No