Depressive SymptomsNCT01407926
Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients
An observational study of Depressive Symptoms, run by McMaster University at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Depressive Symptoms
- What is being tested?
- Nurse-Led Mental Health Promotion Intervention
- How many people
- 142 participants
- Where
- 1 siteCanada
- Study dates
- May 2010to Jun 2013
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: Older home care clients receiving personal support services through a home care program in Southern Ontario
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Depressive Symptoms
- Being tested
- Nurse-Led Mental Health Promotion Intervention
- Keywords
- Depression, Aging, Clinical Effectiveness, Home Care, Nurse-Led
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-Led Mental Health Promotion InterventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: Nurse-Led Mental Health Promotion Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Centre for Epidemiological Studies in Depression Scale
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.
Measured: Baseline to 12 months
Secondary outcomes (11)
Generalized Anxiety Disorder Screener
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:
- 0-5 = Mild anxiety
- 6-10 = Moderate anxiety
- 11-15 = Moderately severe anxiety
- 15-21 = Severe anxiety
When used as a screening tool, further evaluation is recommended when the score is 10 or greater
Measured: Baseline and 12 months
SF-12 Physical Composite Index
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
Measured: 12 months minus Baseline value
SF-12 Physical Functioning Index
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.
Measured: Baseline and 12 months
SF-12 Role Limitation Physical Index
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.
Measured: Baseline and 12 months
SF-12 Pain Index Score
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.
Measured: Baseline and 12 months
SF-12 General Health Index
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.
Measured: Baseline and 12 months
SF-12 Mental Health Composite Index
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.
Measured: Baseline and 12 months
SF-12 Vitality Index Score
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.
Measured: Baseline and 12 months
SF-12 Social Functioning Index
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.
Measured: Baseline and 12 months
SF-12 Role Limitation Emotional Index
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.
Measured: Baseline and 12 months
SF-12 Mental Health Index
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.
Measured: Baseline and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2011 (estimated)
- Study startMay 2010
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Depressive SymptomsStudies of the same condition, open and under way.
- More trials run by McMaster UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 142 participants (actual)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Maureen F Markle-Reid, RN, PhD, Principal investigator, McMaster University, School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01407926
- Sponsor's protocol ID
- PHE-101531
- Other IDs
- 06510
- Status last verified
- Mar 2019
- First submitted
- 1 Aug 2011
- Last updated
- 7 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
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.
PubMed 24886344Markle-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.
PubMed 21867539
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of a Nurse-Led Interprofessional Mental Health Promotion Intervention Among Older Home Care Clients
- ClinicalTrials.gov ID
- NCT01407926
- Acronym / sponsor ID
- PHE-101531
- Conditions
- Depressive Symptoms
- Keywords
- Depression, Aging, Clinical Effectiveness, Home Care, Nurse-Led
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 142 participants (actual)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR), Ontario Ministry of Health and Long Term Care
- Study start
- May 2010
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 2 Aug 2011 (estimated)
- Results
- Posted 7 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | – | Other: Nurse-Led Mental Health Promotion InterventionInterprofessional 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 |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Older home care clients receiving personal support services through a home care program in Southern Ontario
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-Led Mental Health Promotion InterventionThe 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. | Other | Nurse-Led Mental Health Promotion Group |
Primary outcome
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.
11 secondary outcomes
Generalized Anxiety Disorder Screener
Time frame: Baseline and 12 months
SF-12 Physical Composite Index
Time frame: 12 months minus Baseline value
SF-12 Physical Functioning Index
Time frame: Baseline and 12 months
SF-12 Role Limitation Physical Index
Time frame: Baseline and 12 months
SF-12 Pain Index Score
Time frame: Baseline and 12 months
SF-12 General Health Index
Time frame: Baseline and 12 months
SF-12 Mental Health Composite Index
Time frame: Baseline and 12 months
SF-12 Vitality Index Score
Time frame: Baseline and 12 months
SF-12 Social Functioning Index
Time frame: Baseline and 12 months
SF-12 Role Limitation Emotional Index
Time frame: Baseline and 12 months
SF-12 Mental Health Index
Time frame: Baseline and 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24886344Markle-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.
- Derived from this study: PubMed 21867539Markle-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maureen F Markle-Reid, RN, PhD principal investigator
McMaster University, School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depressive Symptoms, run by McMaster University at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Centre for Epidemiological Studies in Depression Scale (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01407926, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2019.