- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01407926
Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients
The Effects of a Nurse-Led Interprofessional Mental Health Promotion Intervention Among Older Home Care Clients
Objective: The objective of this study is to evaluate the feasibility, acceptability and effectiveness of a 6-month nurse-led, interprofessional mental health promotion intervention aimed at older home care clients with depressive symptoms using personal support services.
Methods/Design: This one-group pre-test post-test study aims to recruit a total of 250 long-stay (> 60 days) home care clients, 70 years or older, with depressive symptoms who are receiving personal support services through a home care program in Ontario, Canada. The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach. The primary outcome is the change in severity of depressive symptoms from baseline to 6 months using the Centre for Epidemiological Studies in Depression Scale. Secondary outcomes include changes in the prevalence of depressive symptoms and anxiety, health-related quality of life, cognitive function, and the rate and appropriateness of depression treatment from baseline to 12 months. Changes in the costs of use of health services will be assessed from a societal perspective.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
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Ontario
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Hamilton, Ontario, Canada, L8N 3Z5
- McMaster University, School of Nursing
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- long-stay (> 60 days) home care clients
- 70 years or older
- newly referred to and receiving PSS through the CCAC
- living in the community (not in a long-term care home)
- mentally competent to give informed consent (or with a substitute decision-maker available)
- competent in English (or with an interpreter available)
- screens positive for depressive symptoms
Exclusion Criteria:
- receiving palliative care services
- not competent in English and no interpreter available
- not mentally competent to give informed consent and no substitute decision-maker available
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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Nurse-Led Mental Health Promotion Group
Interprofessional nurse-led strategy involving regular home visits over 6 months by an RN and PSW.
The RN will conduct a comprehensive health assessment and screen clients for risk factors for depression and other chronic conditions, implement health promotion strategies to address this risk factors and enhance health, review their medications, conduct in-home exercise , refer clients to other health services
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The nurse-led intervention is a multi-faceted 6-month program led by a Registered Nurse that involves regular home visits, monthly case conferences, and evidence-based assessment and management of depression using an interprofessional approach.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Centre for Epidemiological Studies in Depression Scale
Time Frame: Baseline to 12 months
|
The CES-D consists of 20 items, which range from 0-60, with higher scores indicating greater severity of depressive symptoms.
It has been used in prior randomized controlled trials by three of the study investigators that involved older home care clients with mood disorders and has a high degree of reliability, content, construct and criterion related validity, distinguishes between depressed and non-depressed people, and is a sensitive tool for measuring changes in depressive symptoms over time in psychiatric populations.
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Baseline to 12 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Generalized Anxiety Disorder Screener
Time Frame: Baseline and 12 months
|
The Generalised Anxiety Disorder Assessment (GAD-7) is a seven item instrument that is used to measure or assess the severity of generalised anxiety disorder (GAD). Each item asks the individual to rate the severity of his or her symptoms over the past two weeks. Response options include "not at all", "several days", "more than half the days" and "nearly every day". The GAD-7 score is calculated by assigning scores of 0, 1, 2, and 3, to the response categories of "not at all," "several days," "more than half the days," and "nearly every day," respectively, and then adding together the scores for the seven questions. GAD-7 total score for the seven items ranges from 0 to 21. Scores represent:
When used as a screening tool, further evaluation is recommended when the score is 10 or greater |
Baseline and 12 months
|
|
SF-12 Physical Composite Index
Time Frame: 12 months minus Baseline value
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means a better outcome
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12 months minus Baseline value
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SF-12 Physical Functioning Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
|
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SF-12 Role Limitation Physical Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
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SF-12 Pain Index Score
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
|
Baseline and 12 months
|
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SF-12 General Health Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
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SF-12 Mental Health Composite Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
|
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SF-12 Vitality Index Score
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
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SF-12 Social Functioning Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
|
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SF-12 Role Limitation Emotional Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
|
Baseline and 12 months
|
|
SF-12 Mental Health Index
Time Frame: Baseline and 12 months
|
The SF-12 is a multipurpose short form to measure health status.
There are 10 domains: Physical Composite Index (score range from 0-100); Physical Functioning Index (score range from 0-100); Role Limitation Physical Index (score range 0-100); Pain Index Score (score range from 0-100); General Health Index (score range from 0-100); Mental Health Composite Index (score range from 1-100); Vitality Index (score range from 0-100); Social Functioning Index (score rang 0-100); Role Limitation Emotional Index (score range 0-100); and SF-12 Mental Health Index (score range from 0-100), the higher the score means the better the outcome.
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Baseline and 12 months
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maureen F Markle-Reid, RN, PhD, McMaster University, School of Nursing
Publications and helpful links
General Publications
- Markle-Reid M, McAiney C, Forbes D, Thabane L, Gibson M, Browne G, Hoch JS, Peirce T, Busing B. An interprofessional nurse-led mental health promotion intervention for older home care clients with depressive symptoms. BMC Geriatr. 2014 May 10;14:62. doi: 10.1186/1471-2318-14-62.
- Markle-Reid MF, McAiney C, Forbes D, Thabane L, Gibson M, Hoch JS, Browne G, Peirce T, Busing B. Reducing depression in older home care clients: design of a prospective study of a nurse-led interprofessional mental health promotion intervention. BMC Geriatr. 2011 Aug 25;11:50. doi: 10.1186/1471-2318-11-50.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PHE-101531
- 06510 (Other Grant/Funding Number: Ontario Ministry of Health and Long-Term Care)
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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