- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04078282
The Use of Collaborative Care in General Practice for Elderly Patients With Depression
February 20, 2024 updated by: Erik L Werner, University of Oslo
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Oslo, Norway
- University of Oslo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (Older Adult)
Accepts Healthy Volunteers
Yes
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Active treatment group
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.
|
see above
|
Active Comparator: Control group
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.
|
see above
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with a change in clinical significant depression
Time Frame: At start and at 12 and 18 month following treatment
|
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.
|
At start and at 12 and 18 month following treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of patients with a change in the level of anxiety
Time Frame: At start and at 12 and 18 month following treatment
|
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.
|
At start and at 12 and 18 month following treatment
|
Number of Subjective Health Complaints among patients with depression
Time Frame: At start and at 12 and 18 month following treatment
|
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.
|
At start and at 12 and 18 month following treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jørund Straand, PhD, University of Oslo
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 15, 2019
Primary Completion (Actual)
September 30, 2022
Study Completion (Actual)
December 30, 2023
Study Registration Dates
First Submitted
August 27, 2019
First Submitted That Met QC Criteria
September 2, 2019
First Posted (Actual)
September 6, 2019
Study Record Updates
Last Update Posted (Estimated)
February 21, 2024
Last Update Submitted That Met QC Criteria
February 20, 2024
Last Verified
February 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- LCKO001
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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