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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Norway
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Oslo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 15, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 27, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 2, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 21, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 20, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Depression in Old Age

Clinical Trials on Intervention group

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings