Integrated Depression Care

NCT05788198 | Recruiting

• 1 other identifier: NOPRODDEP4002
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 2

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).

Conditions

Depression Mild; Depression Moderate; Depression Severe

Outcome Measures

Primary Outcomes (1)

• Intervention integration

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

  14 months

Secondary Outcomes (6)

• Depression

  12 months

• Depression and anxiety

  12 months

• Medication adherence and self-efficacy

  12 months

• Resource use

  12 months

• Health-related Quality of Life

  12 months

Study Arms (1)

Integrated care arm

EXPERIMENTAL

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

Interventions

Integrated care OTHER

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: 1. empowering and engaging people and communities; 2. strengthening governance and accountability; 3. reorienting the model of care; 4. coordinating services within and across sectors; 5. creating an enabling environment.

Integrated care arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persons between 18-65
• presenting to the general practitioner's office
• with depressive symtomatology

You may not qualify if:

• Severe depression warranting direct referral to specialized services

Sponsors & Collaborators

• University Ghent: lead
• Universiteit Antwerpen: collaborator
• Janssen-Cilag Ltd.: collaborator

Study Sites (2)

ELZ Mechelen-Katelijne

Mechelen, 2800, Belgium

RECRUITING

ELZ Voorkempen

Zoersel, 2980, Belgium

RECRUITING

MeSH Terms

Interventions

Delivery of Health Care, Integrated

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Liesbeth Borgermans, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Lieven Annemans, PhD

  University Ghent

  STUDY CHAIR

Central Study Contacts

Ruben P Willems, PhD

CONTACT

+32488307749; ruben.willems@ugent.be

Liesbeth Borgermans, PhD

CONTACT

+32473991090; liesbeth.borgermans@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigators, care providers, and participants will know treatment arm allocation.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Pre/Posttest implementation study.

Study Record Dates

• First Submitted: November 19, 2021
• First Posted: March 28, 2023
• Study Start: April 25, 2023
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2024
• Last Updated: June 6, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (2)