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

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ClinicalTrials.gov Identifier: NCT04078282
Recruitment Status : Not yet recruiting
First Posted : September 5, 2019
Last Update Posted : September 25, 2019
Sponsor:
Information provided by (Responsible Party):
Erik L Werner, University of Oslo

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
Depression in Old Age Behavioral: Intervention group Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 group
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Use of Collaborative Care in General Practice for Elderly Patients With Depression
Estimated Study Start Date : September 15, 2019
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of patients with a change in clinical significant depression [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.



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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04078282


Contacts
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Contact: Lars C Kvalbein-Olsen, MD +47 99005359 larsco@gmail.com
Contact: Erik L. Werner, PhD +47 91768413 e.l.werner@medisin.uio.no

Sponsors and Collaborators
University of Oslo
Investigators
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Study Director: Jørund Straand, PhD University of Oslo

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Responsible Party: Erik L Werner, Professor, University of Oslo
ClinicalTrials.gov Identifier: NCT04078282     History of Changes
Other Study ID Numbers: LCKO001
First Posted: September 5, 2019    Key Record Dates
Last Update Posted: September 25, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Erik L Werner, University of Oslo:
Depression
Elderly
Family Practice
Additional relevant MeSH terms:
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Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders