Integrated Depression Care (IDECA)

Integrated Depression Care Project

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).

Study Overview

• Status: Recruiting
• Conditions: Depression Moderate; Depression Severe; Depression Mild
• Intervention / Treatment: Other: Integrated care

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 Type: Interventional
• Enrollment (Estimated): 150
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ruben P Willems, PhD; Phone Number: +32488307749; Email: ruben.willems@ugent.be
• Study Contact Backup: Name: Liesbeth Borgermans, PhD; Phone Number: +32473991090; Email: liesbeth.borgermans@ugent.be

Study Locations

• Belgium
  • Mechelen, Belgium, 2800
    • Recruiting
    • ELZ Mechelen-Katelijne
    • Contact: Willy Heylen, MSc; Phone Number: 0474 69 54 05; Email: willy.heylen@elzmechelenkatelijne.be
  • Zoersel, Belgium, 2980
    • Recruiting
    • ELZ Voorkempen
    • Contact: Lavinia Vervecken, MSc; Phone Number: +32(0)3 380 30 11; Email: Lavinia.Vervecken@Emmaus.be

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intervention integration	Nomad questionnaire (4 monthly), followed by focus groups following Balint method, and individual interviews.	14 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Depression and anxiety	OQ-45-2 (Outcome Questionnaire. Transdiagnostical instrument focused on anxiety and depression) Total Score; Total scores (≥ 64) reflect increased distressHigh is anything above 105Moderately High is between 83 and 105Moderate is between 64 and 82Low 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
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
Resource use	iMCQ (The iMTA Medical Consumption Questionnaire) to capture depression-related resource use	12 months
Health-related Quality of Life	EQ5D5L (EuroQol 5 Dimensions 5 levels). Score 0 equals death and 1 perfect health.	12 months
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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: Universiteit Antwerpen; Janssen-Cilag Ltd.
• Investigators: Principal Investigator: Liesbeth Borgermans, PhD, University Ghent; Study Chair: Lieven Annemans, PhD, University Ghent

Study record dates

Study Major Dates

• Study Start (Actual): April 25, 2023
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: November 19, 2021
• First Submitted That Met QC Criteria: March 27, 2023
• First Posted (Actual): March 28, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: NOPRODDEP4002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: None, except anonymized data for peer review.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No