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Trial record 3 of 6093 for:    "Depressive Disorder" [DISEASE]

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

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ClinicalTrials.gov Identifier: NCT03668457
Recruitment Status : Not yet recruiting
First Posted : September 12, 2018
Last Update Posted : September 12, 2018
Sponsor:
Collaborator:
University of La Laguna
Information provided by (Responsible Party):
Servicio Canario de Salud

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.


Condition or disease Intervention/treatment Phase
Depressive Disorder Behavioral: Intervention to Patients Behavioral: Intervention to Psychiatrists Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Effectiveness and Cost-effectiveness of a Multi-component Intervention to Improve Medication Adherence in People With Depressive Disorders
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention to Patients
Only patients receive intervention
Behavioral: 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.

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

Experimental: Intervention to Psychiatrists
Psychiatrists receive the intervention. Their associated patients do not receive direct intervention although indirect intervention through professionals
Behavioral: 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

Experimental: Mixed Intervention
Patients and Psychiatrists associated with these patients receive intervention
Behavioral: 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.

Behavioral: 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

Control
Psychiatrists provide the usual care Patients receive usual care
Other: Control
Other: Usual care Usual care for depressive disorder received in mental health units




Primary Outcome Measures :
  1. Change in the Sidorkiewicz instrument score [ Time Frame: Baseline and 6 months ]
    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).


Secondary Outcome Measures :
  1. Change in the Sidorkiewicz instrument score [ Time Frame: Baseline, 3 and 12 months ]
    Change in adherence from baseline to 3 and 12 months.

  2. Change in Beck Depression Inventory - II (BDI-II) score [ Time Frame: Baseline, 3, 6, and 12 months ]
    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.

  3. Change in Hospital Anxiety and Depression Scale (HADS) score [ Time Frame: Baseline, 3, 6, and 12 months ]
    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).

  4. Change in Physical Functioning Subscale (PF-10) of the 36-item Short Form Health Survey (SF-36) [ Time Frame: Baseline, 6, and 12 months ]
    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).

  5. Change in EQ-5D-5L [ Time Frame: Baseline, 6, and 12 months ]
    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).

  6. Change in Patient-Practitioner Orientation Scale (PPOS) score [ Time Frame: Baseline and 12 months ]
    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).


Other Outcome Measures:
  1. Healthcare utilization, cost and productivity losses [ Time Frame: Baseline, 6, and 12 months ]
    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.

  2. The Control Preferences Scale (CPS) [ Time Frame: Baseline ]
    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).

  3. Drug Attitude Inventory (DAI) [ Time Frame: Baseline ]
    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.

  4. Form C of the Multidimensional Health Locus of Control Scales (MHLC-C) [ Time Frame: Baseline ]
    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.

  5. The Hong Psychological Reactance Scale (HPRS) [ Time Frame: Baseline ]
    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).

  6. Beliefs about Medicines Questionnaire (BMQ) [ Time Frame: Baseline ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients:

    • Patients with diagnosis of depressive disorder 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03668457


Contacts
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Contact: María del Mar Trujillo Martín, PhD +34 922 684019 ext 209 mar.trujillomartin@sescs.es
Contact: Tasmania del Pino-Sedeño, PhD +34922316502 ext 6366 tdpino@ull.edu.es

Locations
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Spain
Servicio de Evaluación. Servicio Canario de Salud
Santa Cruz de Tenerife, Spain, 38004
Sponsors and Collaborators
Servicio Canario de Salud
University of La Laguna
Investigators
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Principal Investigator: 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: Wenceslao Peñate Castro University of La Laguna

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Servicio Canario de Salud
ClinicalTrials.gov Identifier: NCT03668457     History of Changes
Other Study ID Numbers: PI18-00767
First Posted: September 12, 2018    Key Record Dates
Last Update Posted: September 12, 2018
Last Verified: July 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Servicio Canario de Salud:
Depression
Medication adherence
Multicomponent intervention

Additional relevant MeSH terms:
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Disease
Depressive Disorder
Depression
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms