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Trial record 43 of 1323 for:    Recruiting, Not yet recruiting, Available Studies | "Depression"

Development and Assessment of the Implementation of a Collaborative Care Approach for Depression in Primary Care

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ClinicalTrials.gov Identifier: NCT03285659
Recruitment Status : Not yet recruiting
First Posted : September 18, 2017
Last Update Posted : September 18, 2017
Sponsor:
Information provided by (Responsible Party):
Jordi Gol i Gurina Foundation

Brief Summary:
Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in depression diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. It is intended to be implemented in clinical practice within the context of primary care.

Condition or disease Intervention/treatment Phase
Depression Other: Intervention: INDI Implementation Not Applicable

Detailed Description:

BACKGROUND Depression is one of the most common conditions among primary care patients. Nevertheless, there are several problems in its diagnosis, clinical management and outcomes. The INDI study, which is based in a collaborative care model, aims to improve the management of depression in primary care patients. INDI has been proved previously to be an efficient intervention showing clinical and socio-economic benefits. INDI is intended to be implemented in the clinical practice within the context of primary care.

METHOD Aim: Test the feasibility and the impact of an implementation strategy of the INDI model for the management of depression in primary care.

Design: This is a casi-experimental study within the context of primary care. Specific geographic areas will be identified to implement the INDI program (intervention group) and other areas with similar features will to be compared (control group.

Participants: Patients diagnosed with depression will be invited to voluntarily participate in this study. Additionally, the investigators will also consider as participants the health professionals, the centres of primary care, as well as the health organizations of the geographic areas where the study will take place: Camp de Tarragona and Valles Occidental (Catalonia, Spain).

Intervention: The INDI model is a health care program for improving the management of depression. INDI includes clinical, training and organizational interventions with the participation of nurses as care managers. An active strategy based on the Promoting Action on Research Implementation in Health Services's model (PARIHS) will be designed for the implementation.

Evaluation: This study will use qualitative and quantitative methods to obtain data on the variables related to a successful implementation: feasibility, acceptability, and impact.

Discussion: In this study, the investigators aim to test the feasibility of a clinical intervention INDI, based on a collaborative care model, in the management of depression in primary care setting. If the implementation of such intervention is successful, then the achieved data and experience will help to plan a strategy to generalize the INDI model to the Catalan health system. The investigators expect significant clinical benefits to the patients, the health system and to the society.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Study Protocol: Development and Assessment of an Active Strategy for the Implementation of a Collaborative Care Approach for Depression in Primary Care. The INDI·i Project
Estimated Study Start Date : January 1, 2018
Estimated Primary Completion Date : July 1, 2019
Estimated Study Completion Date : December 31, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention: INDI Implementation
Primary care centres which will implement the collaborative (INDI) care model for depression
Other: Intervention: INDI Implementation
Implementation of a collaborative care model in the context of primary care to manage depression
Other Name: INDI

No Intervention: Control: no INDI implementation
Primary care centres in which the collaborative care strategy INDI will not be implemented, but will be compared in terms of their clinical practice towards depression



Primary Outcome Measures :
  1. degree of implementation and capacity for change of the collaborative care model (INDI) [ Time Frame: 12 months ]
    degree of implementation of the collaborative care model (INDI) in health organization and professionals using the Assessment of Readiness for Chronicity in Health Care Organizations (ARCHO)

  2. patient experience about the collaborative care model (INDI) [ Time Frame: 12 months ]
    how patients experience depression care according to the collaborative care model (INDI) using the Instrument for Evaluating Patient Experience of Chronic Illness Care (IEXPAC) scale



Information from the National Library of Medicine

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

Inclusion Criteria:

  • Patients: adult patients with a new diagnosis of depression or a new episode of antidepressant treatment. The comorbidity of depression with other common mental disorders such as anxiety disorders or somatization disorders is not an exclusion criterion.
  • Organization: Health centres (i.e. Primary care centres) of Catalonia, which are comparable in terms of their sociodemographic, healthy and organizational features

Exclusion Criteria:

  • Patients: adult patients with a diagnosis of psychotic or bipolar disorder, drug or alcohol use disorder, dementia, intellectual disability, postpartum depression, and patients included in the home care program
  • Organization: no exclusion criteria

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): NCT03285659


Contacts
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Contact: Catarina Pires, PhD 0034 652957478 jamnista@gmail.com

Sponsors and Collaborators
Jordi Gol i Gurina Foundation
Investigators
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Principal Investigator: Enric Aragonès, PhD Jordi Gol Fundation

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jordi Gol i Gurina Foundation
ClinicalTrials.gov Identifier: NCT03285659     History of Changes
Other Study ID Numbers: P17/077
First Posted: September 18, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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 Jordi Gol i Gurina Foundation:
depression
Primary Health Care
Health Plan Implementation
Collaborative care
Patient-Centered Care
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders
indicine-N-oxide
Antineoplastic Agents, Phytogenic
Antineoplastic Agents