Integrated Depression Care

Not Applicable

Recruiting

• Conditions: Depression Mild; Depression Moderate; Depression Severe
• Interventions: Other: Integrated care

• Registration Number: NCT05788198
• Lead Sponsor: University Ghent

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).

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 Timeline

• Study First Submitted: 2021-11-19
• Study First Submitted QC: 2023-03-27
• Study First Posted: 2023-03-28
• Study Start: 2023-04-25
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-05
• Last Update Posted: 2024-06-06
• Primary Completion: 2024-09-30
• Study Completion: 2024-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 150

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Integrated care arm	Integrated care	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).

Primary Outcome Measures

Name	Time	Method
Intervention integration	14 months	Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.

Secondary Outcome Measures

Name	Time	Method
Resource use	12 months	iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use
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)
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.
Health-related Quality of Life	12 months	EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.
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
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.

Trial Locations

Locations (2)

ELZ Voorkempen; 🇧🇪 Zoersel, Belgium

ELZ Mechelen-Katelijne; 🇧🇪 Mechelen, Belgium