Trial Outcomes & Findings for Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients (NCT NCT01407926)

NCT ID: NCT01407926

Last Updated: 2019-06-07

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 142 participants
• Primary outcome timeframe: Baseline to 12 months
• Results posted on: 2019-06-07

Participant Flow

Participant milestones

Measure	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.
Overall Study STARTED	142
Overall Study COMPLETED	87
Overall Study NOT COMPLETED	55

Reasons for withdrawal

Measure

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.

Overall Study Lost to Follow-up

55

Baseline Characteristics

Nurse-Led Interprofessional Mental Health Promotion Intervention for Older Home Care Clients

Baseline characteristics by cohort

Measure	Nurse-Led Mental Health Promotion Group n=142 Participants 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.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	142 Participants n=93 Participants
Age, Continuous	82 years STANDARD_DEVIATION 5.7 • n=93 Participants
Sex: Female, Male Female	92 Participants n=93 Participants
Sex: Female, Male Male	50 Participants n=93 Participants
Region of Enrollment Canada	142 participants n=93 Participants

PRIMARY outcome

Timeframe: Baseline to 12 months

Population: 12 months minus baseline value

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.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=79 Participants 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.

Centre for Epidemiological Studies in Depression Scale

-3.52 units on a scale Interval -5.77 to -1.27

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 12 months minus Baseline value

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

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

Generalized Anxiety Disorder Screener

-1.83 units on a scale Interval -3.03 to -0.62

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Physical Composite Index

8.70 units on a scale Interval 3.65 to 13.75

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Physical Functioning Index

6.88 units on a scale Interval -0.37 to 14.12

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Role Limitation Physical Index

15.47 units on a scale Interval 6.87 to 24.07

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Pain Index Score

5.94 units on a scale Interval -3.1 to 14.98

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 General Health Index

-0.25 units on a scale Interval -6.31 to 5.81

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Mental Health Composite Index

8.96 units on a scale Interval 3.69 to 14.23

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Vitality Index Score

8.75 units on a scale Interval 0.39 to 17.11

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Social Functioning Index

4.38 units on a scale Interval -8.57 to 17.32

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Role Limitation Emotional Index

10.31 units on a scale Interval 1.09 to 19.53

SECONDARY outcome

Timeframe: Baseline and 12 months

Population: 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 the better the outcome.

Outcome measures

Measure

Nurse-Led Mental Health Promotion Group n=80 Participants 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.

SF-12 Mental Health Index

10.00 units on a scale Interval 3.53 to 16.47

Adverse Events

Nurse-Led Mental Health Promotion Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Maureen Markle-Reid, Associate Professor and Canada Research Chair, School of Nursing

McMaster University

Phone: 905-525-9140

Email: mreid@mcmaster.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place