Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03157999
Other study ID # RFHSC 2000003756
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date July 25, 2017
Est. completion date June 15, 2020

Study information

Verified date March 2023
Source McMaster University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of this study is to test a support program for older adults with symptoms of depression and other chronic health problems after they are discharged home from hospital. The study will be conducted in three communities in Ontario (Sudbury, Burlington, and Hamilton) and the program will be implemented with input from community members. The program will be delivered by a Registered Nurse, who will provide support to patients via home visits and telephone calls. The nurse's role will involve linking patients and their caregivers with needed services and supports, reviewing medications that the patients are taking, assessing patients' health, building the skills of patients in problem-solving and managing their care, and providing education to patients and their caregivers.


Description:

Implementing transitional care interventions for older adults with depressive symptoms and multiple chronic conditions (MCC) is a pressing concern since older adults with depression face persistent health disparities. The Community Assets Supporting Transitions (CAST) research team seeks to address these health inequities, and improve health outcomes in this vulnerable and under-served population by developing and implementing an intervention that will improve patients' self-management ability, support their families and caregivers, and build capacity for primary care and other health and non-health providers to collaborate in delivering home and community services. The proposed study builds on our pilot study that evaluated a nurse-led intervention for older adult home care clients with MCC and depressive symptoms and demonstrated that the intervention was feasible and effective in reducing depressive symptoms. The overall aim of the study is to improve care transitions in older adults with MCC and depressive symptoms. The project will address three research questions: 1. What is the effect of a new, nurse-led hospital-to-home transitional care intervention compared to usual care on health outcomes and costs for older adults with MCC and depressive symptoms? 2. How is a care transition intervention adapted and implemented in diverse settings? 3. What is required to sustain and scale up the intervention? We hypothesize that the intervention will improve health outcomes and reduce use of expensive health services compared to usual care at no additional cost, from a societal perspective.


Recruitment information / eligibility

Status Completed
Enrollment 127
Est. completion date June 15, 2020
Est. primary completion date June 15, 2020
Accepts healthy volunteers No
Gender All
Age group 65 Years and older
Eligibility Inclusion Criteria: - Is an adult, age 65 or older; - Is planned for discharge from hospital to the community (this includes retirement homes and transitional care beds); - Self-reports having a diagnosis of at least two chronic conditions; - Is experiencing depressive symptoms, assessed using the 2-item version of the Patient Health Questionnaire (PHQ-2); - Lives within one of the study regions (Sudbury, Burlington, or Hamilton), and is not planning to move out of the region during the trial (defined as a one-year period); - Is capable of providing informed consent, or has a substitute decision-maker who is able to provide informed consent on his/her behalf; and - Is competent in English, or has an interpreter who is competent in English. Exclusion Criteria: - Is being discharged from the hospital to a long-term care home or tertiary care.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Intervention group (CAST)
Intervention duration is expected to be 6 months. A full-time registered nurse (RN) will function as a Care Transitions Coordinator (CTC) who works collaboratively with one local hospital and other health and non-health representatives to deliver the intervention, which includes: care coordination and system navigation (including facilitating timely primary care follow-up); medication management; assessing the needs and risk of the participants (including in-depth assessment of depressive symptoms); evidence-based management of depressive symptoms and other chronic conditions to prevent the onset and worsening of other chronic conditions; patient and caregiver education; and goal setting and problem-solving therapy.

Locations

Country Name City State
Canada Joseph Brant Hospital Burlington Ontario
Canada Hamilton General Hospital Hamilton Ontario
Canada School of Nursing, McMaster University Hamilton Ontario
Canada Health Sciences North/Laurentian University Sudbury Ontario

Sponsors (6)

Lead Sponsor Collaborator
McMaster University Canadian Institutes of Health Research (CIHR), Institute for Clinical Evaluative Sciences, Labarge Optimal Aging Initiative, Laurentian University, The Ontario Spor Support Unit

Country where clinical trial is conducted

Canada, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Change in mental functioning of the older adult study participant Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12). T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in mental functioning of the family/friend caregiver of older adult participant (if applicable). Measured by the mental component summary (MCS) score of the Veterans RAND 12 item Health Survey (VR-12). T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). Measured by the physical component summary (PCS) score of the Veterans RAND 12 item Health Survey (VR-12). T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). Measured by the Veterans RAND 12 item Health Survey (VR-12). T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured by the CESD-10 to determine the presence and severity of depressive symptoms. T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured by the GAD-7 (24). T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in caregiver strain of the family/friend caregiver of the older adult study participant (if applicable) As measured by the Modified Caregiver Strain Index T1 = Baseline data collection; TT2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in utilization of health and social services by the: 1) older adult study participant, 2) family/friend caregiver of the older adult study participant. As measured by the Health and Social Services Utilization Inventory T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in utilization of health services by the older adult study participant As identified through Institute for Clinical Evaluative Sciences (ICES) databases T2 = 6 months after randomization; T3 = 12 months after randomization
Secondary Change in unmet care needs of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured through the Unmet Care Needs questionnaire (developed using input from patient/caregiver co-researchers to ensure the inclusion of outcomes that are relevant and meaningful to patients and caregivers). T1 = Baseline data collection; T2 = 6 months after randomization
Secondary Change in patient-provider communication of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured through the Patient-Provider Communication (PCC) questionnaire. T1 = Baseline data collection; T2 = 6 months after randomization
Secondary Change in patient-reported experience (CCCQ) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured through the adapted Client-Centred Care Questionnaired (CCCQ). T1 = Baseline data collection; T2 = 6 months after randomization
Secondary Change in patient-reported experience (IC-PREMs) for the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable). As measured through the adapted Integrated Care Patient-Reported Experience Measures (IC-PREMs). T1 = Baseline data collection; T2 = 6 months after randomization
See also
  Status Clinical Trial Phase
Completed NCT02909387 - Adapting Project UPLIFT for Blacks in Georgia N/A
Completed NCT05702086 - Making SPARX Fly in Nunavut: Pilot Testing an E-intervention for Boosting Resilience Against Youth Depression N/A
Terminated NCT04921332 - Bright Light Therapy for Depression Symptoms in Adults With Cystic Fibrosis (CF) and COPD N/A
Completed NCT03535805 - Transdiagnostic, Cognitive and Behavioral Intervention for in School-aged Children With Emotional and Behavioral Disturbances N/A
Recruiting NCT06100146 - Effectiveness of Fortification With Folic Acid and Vitamin B12 Among Teenage Girls N/A
Recruiting NCT03272230 - Assessment of Apathy in a Real-life Situation, With a Video and Sensors-based System N/A
Completed NCT03514355 - MBSR in Rheumatoid Arthritis Patients With Controlled Disease But Persistent Depressive Symptoms N/A
Completed NCT05376397 - Testing THRIVE 365 for Black Sexual Minority Men (On The Daily) N/A
Terminated NCT04367636 - The Effects of Attention Training on Emotion Regulation and Stress Related Complaints During COVID-19 N/A
Completed NCT04403126 - To Increase Psychological Well-being by the Implementation of Forgiveness Education N/A
Recruiting NCT05078424 - Cognitive Behavioural Therapy for Youths With Depressive and Anxiety Symptoms in Hong Kong N/A
Recruiting NCT06053775 - Non-Invasive Brain Stimulation and Cognitive Training for Depressive Symptomatology Related to Breast Cancer (ONCODEP) N/A
Active, not recruiting NCT04084795 - Augmentation of EMDR With tDCS in the Treatment of Fibromyalgia N/A
Recruiting NCT04082052 - Evaluating and Predicting Response to a Single Session Intervention for Self-Dislike N/A
Completed NCT04011540 - Digital Data in Mental Health Therapy N/A
Not yet recruiting NCT06413849 - Telephone-coached "Graphic Narrative" Bibliotherapy for Dementia Caregivers N/A
Not yet recruiting NCT03659591 - Triple Aim Psychotherapy: Aimed at Improving Patient Experience, Population Health, and Cost N/A
Not yet recruiting NCT02133170 - "Mindfulness vs Psychoeducation in Bipolar Disorder" N/A
Completed NCT02314390 - Group- Versus Individual-Mindfulness-Based Cognitive Therapy: a Randomized Trial N/A
Completed NCT01628016 - The Effect of Attention Bias Modification Training on Reducing Depressive Symptoms N/A