search
Back to results

The Use of Collaborative Care in General Practice for Elderly Patients With Depression

Primary Purpose

Depression in Old Age

Status
Active
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Intervention group
Sponsored by
University of Oslo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression in Old Age focused on measuring Depression, Elderly, Family Practice

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • all patients visiting one of the collaborative family physicians during the enrollment period of four weeks

Exclusion Criteria:

  • cognitive dysfunction
  • speaking Norwegian language

Sites / Locations

  • University of Oslo

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Active treatment group

Control group

Arm Description

Patients will meet in a joint consultation with their family physician and a psychiatrist for evaluation. Then it follows three treatment sessions with the family physician before a new joint consultation with the psychiatrist. The intervention ends with three more treatment sessions with the family physician.

Patients belonging to family physicians who constitute the control group will be assessed and given treatment according to usual care. This may include treatment by the family physician, medication, referrals to specialized care.

Outcomes

Primary Outcome Measures

Number of patients with a change in clinical significant depression
Change in depression as described by the Patient Health Questionnaire (PHQ-9). The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant.

Secondary Outcome Measures

Number of patients with a change in the level of anxiety
Change in anxiety as described by the Generalized Anxiety Disorder 7-item score GAD-7. The questionnaire is a 7-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.
Number of Subjective Health Complaints among patients with depression
Change in subjective Health Complaints as described by the Subjective Health Complaints questionnaire. The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant. The questionnaire is a 29-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.

Full Information

First Posted
August 27, 2019
Last Updated
November 8, 2022
Sponsor
University of Oslo
search

1. Study Identification

Unique Protocol Identification Number
NCT04078282
Brief Title
The Use of Collaborative Care in General Practice for Elderly Patients With Depression
Official Title
The Use of Collaborative Care in General Practice for Elderly Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
September 15, 2019 (Actual)
Primary Completion Date
September 30, 2022 (Actual)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Oslo

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 first part of this study aims to identify the occurence of depression in the elderly. In the second part, older patients with depression will be invited to a collaborative care with his or her family physician and a psychiatrist specialized in psychiatry in the elderly in accordance with a study protocol. The intervention includes two sessions where the patient will meet the psychiatrist together with the family physician, and between the two sessions the patient will have three treatment sessions with the family physician based on the evaluation by the psychiatrist. Following the last session with the psychiatrist the intervention ends with three more treatment sessions with the family physician.
Detailed Description
The frequency of depression in the elderly is little known and experiences from family practice indicate that older people not always communicate their mental health issues or present physical complaints which may arise from a state of depression. In this study we aim to register the occurence of depression among all patients at the age of 65 or older who visit their family physician. During a period of four weeks, all patients meeting the eligibility criteria will be asked to answer a questionnaire about mental and physic health issues. Those who respond in a manner that gives reasons to believe there is a depression will be contacted by their family physician to meet for a consultation and examination. If this examination confirms the diagnosis the patient will either be treated as usual by their family physician (control group) or be invited to a collaborative care with the family physician in cooperation with a psychiatrist who is specialized in psychiatry in the elderly (intervention group). In the control group the patients will receive usual care at their family physician or be referred to a psychiatrist or a psychologist if appropriate. In the intervention group the patients will have a evaluation session with the family physician and the psychiatrist together. Following this session, the patient and the family physician will meet for three treatment consultations based on the evaluation and recommendations given by the psychiatrist. Then there will be one more joint session with the patient, the family physician and the psychiatrist and the whole treatment program ends with three more treatment consultations at the family physician. - The aim of this intervention is to examine whether this treatment program is more or equally efficient to treat depression in the elderly as usual care and at lower cost and use of specialized care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression in Old Age
Keywords
Depression, Elderly, Family Practice

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Cluster randomized controlled trial where family physicians are to be randomized into interventional or control group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active treatment group
Arm Type
Experimental
Arm Description
Patients will meet in a joint consultation with their family physician and a psychiatrist for evaluation. Then it follows three treatment sessions with the family physician before a new joint consultation with the psychiatrist. The intervention ends with three more treatment sessions with the family physician.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Patients belonging to family physicians who constitute the control group will be assessed and given treatment according to usual care. This may include treatment by the family physician, medication, referrals to specialized care.
Intervention Type
Behavioral
Intervention Name(s)
Intervention group
Intervention Description
see above
Primary Outcome Measure Information:
Title
Number of patients with a change in clinical significant depression
Description
Change in depression as described by the Patient Health Questionnaire (PHQ-9). The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant.
Time Frame
At start and at 12 and 18 month following treatment
Secondary Outcome Measure Information:
Title
Number of patients with a change in the level of anxiety
Description
Change in anxiety as described by the Generalized Anxiety Disorder 7-item score GAD-7. The questionnaire is a 7-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.
Time Frame
At start and at 12 and 18 month following treatment
Title
Number of Subjective Health Complaints among patients with depression
Description
Change in subjective Health Complaints as described by the Subjective Health Complaints questionnaire. The questionnaire is a 9-item questionnaire, each with a 0-4 point scale. A change of 3,9 points in the sumscale is regarded significant. The questionnaire is a 29-item questionnaire, each with a 0-4 point scale. There is no consensus on which level of change is regarded significant.
Time Frame
At start and at 12 and 18 month following treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: all patients visiting one of the collaborative family physicians during the enrollment period of four weeks Exclusion Criteria: cognitive dysfunction speaking Norwegian language
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jørund Straand, PhD
Organizational Affiliation
University of Oslo
Official's Role
Study Director
Facility Information:
Facility Name
University of Oslo
City
Oslo
Country
Norway

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Use of Collaborative Care in General Practice for Elderly Patients With Depression

We'll reach out to this number within 24 hrs