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

Sponsor

Servicio Canario de Salud (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03668457

Collaborator

University of La Laguna (Other)

170

Enrollment

Location

Arms

Anticipated Duration (Months)

5.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depressive Disorder	Behavioral: Intervention to Patients Behavioral: Intervention to Psychiatrists Other: Control	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

170 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Supportive Care

Official Title:

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

Actual Study Start Date :

Mar 1, 2020

Anticipated Primary Completion Date :

Nov 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

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	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 Other: Usual care Usual care for depressive disorder received in mental health units
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. 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 Other: Usual care Usual care for depressive disorder received in mental health units
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

Outcome Measures

Primary Outcome Measures

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

Change in the Sidorkiewicz instrument score [Baseline, 3 and 12 months]
Change in adherence from baseline to 3 and 12 months.
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 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 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).

Other Outcome Measures

Healthcare utilization, cost and productivity losses [Baseline, 6, and 12 months]
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.
The Control Preferences Scale (CPS) [Baseline]
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).
Drug Attitude Inventory (DAI) [Baseline]
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.
Form C of the Multidimensional Health Locus of Control Scales (MHLC-C) [Baseline]
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.
The Hong Psychological Reactance Scale (HPRS) [Baseline]
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).
Beliefs about Medicines Questionnaire (BMQ) [Baseline]
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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Servicio de Evaluación. Servicio Canario de Salud	Santa Cruz de Tenerife		Spain	38004

Sponsors and Collaborators

Servicio Canario de Salud
University of La Laguna

Investigators

Principal Investigator: María del Mar Trujillo Martín, PhD, Servicio de Evaluación del Servicio Canario de la Salud
Principal Investigator: Carlos de las Cuevas Castresana, MD, PhD, University of La Laguna
Principal Investigator: Tasmania del Pino-Sedeño, PhD, University of La Laguna