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
Received 17 October 2018
Accepted for publication 18 January 2019
Published 22 February 2019 Volume 2019:13 Pages 309—319
Checked for plagiarism Yes
Review by Single-blind
Peer reviewers approved by Ms Justinn Cochran
Peer reviewer comments 2
Editor who approved publication: Dr Johnny Chen
Tasmania del Pino-Sedeño,1,2 Wenceslao Peñate,1 Carlos de las Cuevas,3 Cristina Valcarcel-Nazco,2,4 Ascensión Fumero,1 Pedro Guillermo Serrano-Pérez,5,6 Francisco Javier Acosta Artiles,7 Vanesa Ramos García,4 Beatriz León Salas,4 Daniel Bejarano-Quisoboni,8 María M Trujillo-Martín2,4
1Department of Clinical Psychology, Psychobiology and Methodology, University of La Laguna, Canary Islands, Spain; 2Health Services Research on Chronic Patients Network (REDISSEC), Madrid, Spain; 3Department of Internal Medicine, Dermatology and Psychiatry, University of La Laguna, Canary Islands, Spain; 4Canary Islands Foundation of Health Research (FUNCANIS), Canary Islands, Spain; 5Department of Psychiatry, Hospital Universitari Vall d’ Hebron, Catalonia, Spain; 6Department of Psychiatry and Legal Medicine, Universitat Autònoma de Barcelona, Catalonia, Spain; 7Service of Mental Health, General Health Care Programs Direction, Canary Health Service, Canary Islands, Spain; 8Center for Public Health Research (CSISP-FISABIO), Valencia, Spain
Purpose: Depression is a widespread mental disorder which can be treated effectively. However, low adherence to antidepressants is very common. The study of medication adherence in depression (MAPDep study) assesses the effectiveness and cost-effectiveness of a multicomponent strategy to enhance adherence toward medications in patients with depression.
Intervention: The intervention is a multicomponent one consisting of an educational program for psychiatrists and/or a collaborative care program for patients and relatives, plus a reminder system that works through the use of an already available high-quality medication reminder application.
Study design: MAPDep study is an open, multicenter, four-arm cluster randomized controlled trial. The clusters are mental health units where psychiatrists are invited to participate. The clusters are randomly allocated to one of the three interventions or to usual care (control arm). Patients (18–65 years of age) diagnosed with depressive disorder, those taking antidepressant medication for an existing diagnosis of depression, and mobile phone users are selected. In group 1, only patients and relatives receive intervention; in group 2, only psychiatrists receive intervention; and in group 3, patients/relatives and psychiatrists receive intervention. The primary outcome is adherence to the antidepressant drug. The calculated sample size is 400 patients. To examine changes across time, generalized linear mixed model with repeated measures will be used. A cost-effectiveness analysis will be conducted. The effectiveness measure is quality-adjusted life years. Deterministic sensitivity analyses are planned.
Conclusion: MAPDep study aims to assess a multicomponent strategy to improve adherence toward medications in patients with depression, based not only on clinical effectiveness but also on cost-effectiveness. This methodology will enhance the transferability of the expected results beyond mental health services (patients and psychiatrists) to health care policy decision making.
Clinical trial identifier: NCT03668457.
Keywords: depression, medication adherence, education, behavior modification, mobile phone technology, cost-effectiveness
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