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

Sponsor
University of Oslo (Other)
Overall Status
Recruiting
CT.gov ID
NCT04078282
Collaborator
(none)
100
1
2
51.5
1.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Intervention group
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
Cluster randomized controlled trial where family physicians are to be randomized into interventional or control groupCluster randomized controlled trial where family physicians are to be randomized into interventional or control group
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Use of Collaborative Care in General Practice for Elderly Patients With Depression
Actual Study Start Date :
Sep 15, 2019
Anticipated Primary Completion Date :
Jun 30, 2022
Anticipated Study Completion Date :
Dec 31, 2023

Arms and Interventions

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.

Behavioral: Intervention group
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.

Behavioral: Intervention group
see above

Outcome Measures

Primary Outcome Measures

  1. Number of patients with a change in clinical significant depression [At start and at 12 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.

Secondary Outcome Measures

  1. Number of patients with a change in the level of anxiety [At start and at 12 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.

  2. Number of Subjective Health Complaints among patients with depression [At start and at 12 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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Oslo Oslo Norway

Sponsors and Collaborators

  • University of Oslo

Investigators

  • Study Director: Jørund Straand, PhD, University of Oslo

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Erik L Werner, Professor, University of Oslo
ClinicalTrials.gov Identifier:
NCT04078282
Other Study ID Numbers:
  • LCKO001
First Posted:
Sep 6, 2019
Last Update Posted:
Sep 29, 2021
Last Verified:
Sep 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Erik L Werner, Professor, University of Oslo
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 29, 2021