Clinical trial NCT03668457: A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
Official title: Effectiveness and Cost-effectiveness of a Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depressive Disorder
Keywords: Depression
Medication adherence
Multicomponent intervention
Lead sponsor: Servicio Canario de Salud
Sponsor class: OTHER
Collaborators: name: University of La Laguna
First posted: 2018-09-12
Enrollment: 170
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Change in the Sidorkiewicz instrument score
timeFrame: Baseline and 6 months
Secondary outcomes:
measure: Change in the Sidorkiewicz instrument score
timeFrame: Baseline, 3 and 12 months
measure: Change in Beck Depression Inventory - II (BDI-II) score
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Hospital Anxiety and Depression Scale (HADS) score
timeFrame: Baseline, 3, 6, and 12 months
measure: Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36)
timeFrame: Baseline, 6, and 12 months
measure: Change in EQ-5D-5L
timeFrame: Baseline, 6, and 12 months
measure: Change in Patient-Practitioner Orientation Scale (PPOS) score
timeFrame: Baseline and 12 months
Other outcomes:
measure: Healthcare utilization, cost and productivity losses
timeFrame: Baseline, 6, and 12 months
measure: The Control Preferences Scale (CPS)
timeFrame: Baseline
measure: Drug Attitude Inventory (DAI)
timeFrame: Baseline
measure: Form C of the Multidimensional Health Locus of Control Scales (MHLC-C)
timeFrame: Baseline
measure: The Hong Psychological Reactance Scale (HPRS)
timeFrame: Baseline
measure: Beliefs about Medicines Questionnaire (BMQ)
timeFrame: Baseline
Locations:
city: Santa Cruz de Tenerife
country: Spain
facility: Servicio de Evaluación. Servicio Canario de Salud
Study officials:
affiliation: Servicio de Evaluación del Servicio Canario de la Salud
name: María del Mar Trujillo Martín, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of La Laguna
name: Carlos de las Cuevas Castresana, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of La Laguna
name: Tasmania del Pino-Sedeño, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.