Depressive Symptoms
Conditions
Keywords
Depression, Aging, Clinical Effectiveness, Home Care, Nurse-Led
Brief 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. 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.
Interventions
OTHERNurse-Led Mental Health Promotion Intervention
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.
Sponsors
Canadian Institutes of Health Research (CIHR)
Ontario Ministry of Health and Long Term Care
McMaster University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
70 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Centre for Epidemiological Studies in Depression Scale | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SF-12 Physical Composite Index | 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 |
| SF-12 Physical Functioning Index | 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. |
| SF-12 Role Limitation Physical Index | 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. |
| SF-12 Pain Index Score | 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. |
| SF-12 General Health Index | 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. |
| Generalized Anxiety Disorder Screener | 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: * 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 |
| SF-12 Vitality Index Score | 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. |
| SF-12 Social Functioning Index | 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. |
| SF-12 Role Limitation Emotional Index | 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. |
| SF-12 Mental Health Index | 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. |
| SF-12 Mental Health Composite Index | 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. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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
Nurse-Led Mental Health Promotion Intervention : 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. | 142 |
| Total | 142 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 55 |
Baseline characteristics
| Characteristic | Nurse-Led Mental Health Promotion Group |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 142 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants |
| Age, Continuous | 82 years STANDARD_DEVIATION 5.7 |
| Region of Enrollment Canada | 142 participants |
| Sex: Female, Male Female | 92 Participants |
| Sex: Female, Male Male | 50 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 142 |
| other Total, other adverse events | 0 / 142 |
| serious Total, serious adverse events | 0 / 142 |
Outcome results
Primary
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.
Time frame: Baseline to 12 months
Population: 12 months minus baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | Centre for Epidemiological Studies in Depression Scale | -3.52 units on a scale |
Secondary
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
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | Generalized Anxiety Disorder Screener | -1.83 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 General Health Index | -0.25 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Mental Health Composite Index | 8.96 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Mental Health Index | 10.00 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Pain Index Score | 5.94 units on a scale |
Secondary
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
Time frame: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Physical Composite Index | 8.70 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Physical Functioning Index | 6.88 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Role Limitation Emotional Index | 10.31 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Role Limitation Physical Index | 15.47 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Social Functioning Index | 4.38 units on a scale |
Secondary
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.
Time frame: Baseline and 12 months
Population: 12 months minus Baseline value
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nurse-Led Mental Health Promotion Group | SF-12 Vitality Index Score | 8.75 units on a scale |