NCT03668457

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
170

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 9, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
1.5 years until next milestone

Study Start

First participant enrolled

March 1, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

April 12, 2023

Status Verified

April 1, 2023

Enrollment Period

2.7 years

First QC Date

July 9, 2018

Last Update Submit

April 11, 2023

Conditions

Depressive Disorder

Keywords

DepressionMedication adherenceMulticomponent intervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (6)

  • Change in the Sidorkiewicz instrument score

    Baseline, 3 and 12 months

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

    Baseline, 3, 6, and 12 months

  • Change in Hospital Anxiety and Depression Scale (HADS) score

    Baseline, 3, 6, and 12 months

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

    Baseline, 6, and 12 months

  • Change in EQ-5D-5L

    Baseline, 6, and 12 months

  • +1 more secondary outcomes

Other Outcomes (6)

  • Healthcare utilization, cost and productivity losses

    Baseline, 6, and 12 months

  • The Control Preferences Scale (CPS)

    Baseline

  • Drug Attitude Inventory (DAI)

    Baseline

  • +3 more other outcomes

Study Arms (4)

Intervention to Patients

EXPERIMENTAL

Only patients receive intervention

Behavioral: Intervention to PatientsOther: Control

Intervention to Psychiatrists

EXPERIMENTAL

Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals

Behavioral: Intervention to PsychiatristsOther: Control

Mixed Intervention

EXPERIMENTAL

Patients and Psychiatrists associated with these patients receive intervention

Behavioral: Intervention to PatientsBehavioral: Intervention to PsychiatristsOther: Control

Control

OTHER

Psychiatrists provide the usual care Patients receive usual care

Other: Control

Interventions

Intervention to PatientsBEHAVIORAL

Multifaceted intervention consisting of: 1. A collaborative care management intervention, including depression education, medication management and behavioral activation. 2. Use of a medication reminder mobile app.

Intervention to PatientsMixed Intervention
Intervention to PsychiatristsBEHAVIORAL

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.

Intervention to PsychiatristsMixed Intervention
ControlOTHER

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

ControlIntervention to PatientsIntervention to PsychiatristsMixed Intervention

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Servicio de Evaluación. Servicio Canario de Salud

Santa Cruz de Tenerife, 38004, Spain

Location

Related Publications (1)

  • 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.

    PMID: 30863020DERIVED

MeSH Terms

Conditions

Depressive DisorderDepressionMedication Adherence

Condition Hierarchy (Ancestors)

Mood DisordersMental DisordersBehavioral SymptomsBehaviorPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth Behavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2018

First Posted

September 12, 2018

Study Start

March 1, 2020

Primary Completion

November 1, 2022

Study Completion

November 1, 2022

Last Updated

April 12, 2023

Record last verified: 2023-04

Locations

ES(1)