IDECA: Integrated Depression Care

Sponsor
University Ghent (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05788198
Collaborator
Universiteit Antwerpen (Other), Janssen-Cilag Ltd. (Industry)
150
1
14.2

Study Details

Study Description

Brief Summary

The Integrated DEpression CAre (IDECA) Programme is a multi-faceted intervention strategy aiming to improve guideline adherence and shared care practices for depression management in both providers and patients, as measured through a set of process and clinical outcome indicators (primary outcome measure).

Condition or Disease Intervention/Treatment Phase
  • Other: Integrated care
N/A

Detailed Description

The following deliverables apply:
  1. Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels;

  2. Training module for physicians and other care providers in population health management for patients with depression;

  3. Training module for case managers/integration of a case management function into existing depression service offerings;

  4. A patient education module for depression self-management;

  5. A financing model for integrated depression care.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
150 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Pre/Posttest implementation study.Pre/Posttest implementation study.
Masking:
None (Open Label)
Masking Description:
Investigators, care providers, and participants will know treatment arm allocation.
Primary Purpose:
Health Services Research
Official Title:
Integrated Depression Care Project
Anticipated Study Start Date :
Apr 24, 2023
Anticipated Primary Completion Date :
Jun 30, 2024
Anticipated Study Completion Date :
Jun 30, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Integrated care arm

Case management in primary care setting (integration at general practitioners' practices), Depression and population management education for general practitioners, shared care guidance protocol including a medication path (drug classes, no specific drugs specified, based on available depression guidelines in Belgium).

Other: Integrated care
The intervention will be modelled based on the most frequently reported patient, family physician and specialist barriers in depression management. In this project, multiple interventions aiming to tackle these barriers will be set up, with the WHO Framework on Integrated People-Centred Health Services (IPCHS) serving as conceptual backbone to the study (Table 1). The IPCHS distinguishes five interdependent strategies supporting a shift in healthcare delivery, management and funding towards universal health coverage. These strategies are: empowering and engaging people and communities; strengthening governance and accountability; reorienting the model of care; coordinating services within and across sectors; creating an enabling environment.

Outcome Measures

Primary Outcome Measures

  1. Intervention integration [14 months]

    Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.

Secondary Outcome Measures

  1. Depression [12 months]

    PHQ-9 (Patient Health Questionnaire. DSM-5 depression), A PHQ-9 score total of 0-4 points equals "normal" or minimal depression. Scoring between 5-9 points indicates mild depression, 10-14 points indicates moderate depression, 15-19 points indicates moderately severe depression, and 20 or more points indicates severe depression

  2. Depression and anxiety [12 months]

    OQ-45-2 (Outcome Questionnaire. Transdiagnostical instrument focused on anxiety and depression) Total Score Total scores (≥ 64) reflect increased distress High is anything above 105 Moderately High is between 83 and 105 Moderate is between 64 and 82 Low is anything below 64 Symptom Distress (SD) Scores (≥ 37) indicate subjective discomfort Interpersonal Relations (IR) Scores (≥ 16) reflect problems in interpersonal relations. Social Role (SR) Scores (≥ 13) indicate dissatisfaction, conflict, distress, and inadequacy in performance of tasks related to employment, school, family roles and leisure life.

  3. Medication adherence and self-efficacy [12 months]

    MARS-5 (Medication adherence report score) Each item was rated on a 5-point Likert scale, and the range of the MARS-5 total score is between 5 and 25. A higher score on the MARS-5 represents better medication adherence. <21 suboptimal adherence. MUSE (Medication Understanding and Use Self-Efficacy Scale). Score 8-32. Higher scores are better.

  4. Resource use [12 months]

    iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use

  5. Health-related Quality of Life [12 months]

    EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.

  6. Health literacy [12 months]

    HLS-EU-Q16. Considering the HLS-EUQ16 score, three levels of health literacy were defined: - inadequate HL (0-8) - problematic HL (9-12) - adequate HL (13-16)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • persons between 18-65

  • presenting to the general practitioner's office

  • with depressive symtomatology

Exclusion Criteria:
  • Severe depression warranting direct referral to specialized services

Inclusion criteria are kept broad on purpose as it's one of the research questions to define for which patients the intervention (namely the case management) is appropriate.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University Ghent
  • Universiteit Antwerpen
  • Janssen-Cilag Ltd.

Investigators

  • Principal Investigator: Liesbeth Borgermans, PhD, University Ghent
  • Study Chair: Lieven Annemans, PhD, University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University Ghent
ClinicalTrials.gov Identifier:
NCT05788198
Other Study ID Numbers:
  • NOPRODDEP4002
First Posted:
Mar 28, 2023
Last Update Posted:
Mar 28, 2023
Last Verified:
Mar 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 28, 2023