Integrated Depression Care

Depression Mild Clinical Trial

— IDECA  

Official title:

Integrated Depression Care Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05788198
• Other study ID #: NOPRODDEP4002
• Status: Recruiting
• Phase: N/A
• Start date: April 25, 2023
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Ruben P Willems, PhD
• Phone: +32488307749
• Email: ruben.willems[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 150
• Est. completion date: September 30, 2024
• Est. primary completion date: September 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Depression
• Depression Mild
• Depression Moderate
• Depression Severe
• Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Belgium	ELZ Mechelen-Katelijne	Mechelen
Belgium	ELZ Voorkempen	Zoersel

Sponsors (3)

Lead Sponsor	Collaborator
University Ghent	Janssen-Cilag Ltd., Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention integration	Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.	14 months
Secondary	Depression	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	12 months
Secondary	Depression and anxiety	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.	12 months
Secondary	Medication adherence and self-efficacy	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.	12 months
Secondary	Resource use	iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use	12 months
Secondary	Health-related Quality of Life	EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.	12 months
Secondary	Health literacy	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)	12 months