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Integrated Depression Care (IDECA)

Primary Purpose

Depression Mild, Depression Moderate, Depression Severe

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Integrated care
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Depression Mild

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • ELZ Mechelen-KatelijneRecruiting
  • ELZ VoorkempenRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Integrated care arm

Arm Description

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).

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 19, 2021
Last Updated
June 5, 2023
Sponsor
University Ghent
Collaborators
Universiteit Antwerpen, Janssen-Cilag Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05788198
Brief Title
Integrated Depression Care
Acronym
IDECA
Official Title
Integrated Depression Care Project
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 25, 2023 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Universiteit Antwerpen, Janssen-Cilag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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).
Detailed Description
The following deliverables apply: Development and implementation of a shared care protocol for depression management involving primary, secondary and tertiary care levels; Training module for physicians and other care providers in population health management for patients with depression; Training module for case managers/integration of a case management function into existing depression service offerings; A patient education module for depression self-management; A financing model for integrated depression care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression Mild, Depression Moderate, Depression Severe

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Pre/Posttest implementation study.
Masking
None (Open Label)
Masking Description
Investigators, care providers, and participants will know treatment arm allocation.
Allocation
N/A
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ruben P Willems, PhD
Phone
+32488307749
Email
ruben.willems@ugent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Liesbeth Borgermans, PhD
Phone
+32473991090
Email
liesbeth.borgermans@ugent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liesbeth Borgermans, PhD
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lieven Annemans, PhD
Organizational Affiliation
University Ghent
Official's Role
Study Chair
Facility Information:
Facility Name
ELZ Mechelen-Katelijne
City
Mechelen
ZIP/Postal Code
2800
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Willy Heylen, MSc
Phone
0474 69 54 05
Email
willy.heylen@elzmechelenkatelijne.be
Facility Name
ELZ Voorkempen
City
Zoersel
ZIP/Postal Code
2980
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lavinia Vervecken, MSc
Phone
+32(0)3 380 30 11
Email
Lavinia.Vervecken@Emmaus.be

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
None, except anonymized data for peer review.

Learn more about this trial

Integrated Depression Care

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