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

Depressive Disorder Clinical Trial

— MAPDep  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03668457
• Other study ID #: PI18-00767
• Status: Completed
• Phase: N/A
• Start date: March 1, 2020
• Est. completion date: November 1, 2022

Study information

• Verified date: April 2023
• Source: Servicio Canario de Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 170
• Est. completion date: November 1, 2022
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

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.
• 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

Locations

Country	Name	City	State
Spain	Servicio de Evaluación. Servicio Canario de Salud	Santa Cruz de Tenerife

Sponsors (2)

Lead Sponsor	Collaborator
Servicio Canario de Salud	University of La Laguna

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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	Change in the Sidorkiewicz instrument score	Change in adherence from baseline to 3 and 12 months.	Baseline, 3 and 12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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