A Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
NCT ID: NCT03668457
Last Updated: 2023-04-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
170 participants
INTERVENTIONAL
2020-03-01
2022-11-01
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Intervention to Patients
Only patients receive intervention
Intervention to Patients
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.
Control
Other: Usual care Usual care for depressive disorder received in mental health units
Intervention to Psychiatrists
Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
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.
Control
Other: Usual care Usual care for depressive disorder received in mental health units
Mixed Intervention
Patients and Psychiatrists associated with these patients receive intervention
Intervention to Patients
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 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.
Control
Other: Usual care Usual care for depressive disorder received in mental health units
Control
Psychiatrists provide the usual care Patients receive usual care
Control
Other: Usual care Usual care for depressive disorder received in mental health units
Interventions
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Intervention to Patients
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 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.
Control
Other: Usual care Usual care for depressive disorder received in mental health units
Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with history of current bipolar disorder and/or any psychotic disorder
* Insufficient language skills
* Pregnancy
18 Years
65 Years
ALL
No
Sponsors
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University of La Laguna
OTHER
Servicio Canario de Salud
OTHER
Responsible Party
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Principal Investigators
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María del Mar Trujillo Martín, PhD
Role: PRINCIPAL_INVESTIGATOR
Servicio de Evaluación del Servicio Canario de la Salud
Carlos de las Cuevas Castresana, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of La Laguna
Tasmania del Pino-Sedeño, PhD
Role: PRINCIPAL_INVESTIGATOR
University of La Laguna
Locations
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Servicio de Evaluación. Servicio Canario de Salud
Santa Cruz de Tenerife, , Spain
Countries
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References
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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.
Other Identifiers
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PI18-00767
Identifier Type: -
Identifier Source: org_study_id
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