NCT03157999

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
127

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2017

Typical duration for not_applicable

Geographic Reach
1 country

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 12, 2017

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 17, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

July 25, 2017

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

2.9 years

First QC Date

April 12, 2017

Last Update Submit

March 21, 2023

Conditions

ComorbidityDepressive Symptoms

Keywords

Older AdultsTransitional CareCaregiverIntervention

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (12)

  • Change in mental functioning of the family/friend caregiver of older adult participant (if applicable).

    T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

  • Change in physical function of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).

    T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

  • Change in health-related quality of life of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).

    T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

  • Change in depressive symptoms of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).

    T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

  • Change in anxiety of the: 1) older adult study participant, 2) family/friend caregiver of older adult participant (if applicable).

    T1 = Baseline data collection; T2 = 6 months after randomization; T3 = 12 months after randomization

  • +7 more secondary outcomes

Study Arms (2)

Intervention group (CAST)

EXPERIMENTAL

Participants in the intervention group will receive the CAST hospital-to-home transition intervention in addition to usual care.

Behavioral: Intervention group (CAST)

Control group (usual care)

NO INTERVENTION

Participants assigned to the control group will receive usual care at discharge from hospital to home.

Interventions

Intervention group (CAST)BEHAVIORAL

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.

Intervention group (CAST)

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Is being discharged from the hospital to a long-term care home or tertiary care.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Joseph Brant Hospital

Burlington, Ontario, Canada

Location

Health Sciences North/Laurentian University

Greater Sudbury, Ontario, Canada

Location

Hamilton General Hospital

Hamilton, Ontario, L8L 2X2, Canada

Location

School of Nursing, McMaster University

Hamilton, Ontario, L8N 3Z5, Canada

Location

Related Publications (4)

  • 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.

    PMID: 24886344BACKGROUND

  • 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.

    PMID: 21867539BACKGROUND

  • Markle-Reid M, McAiney C, Fisher K, Ganann R, Gauthier AP, Heald-Taylor G, McElhaney JE, McMillan F, Petrie P, Ploeg J, Urajnik DJ, Whitmore C. Effectiveness of a nurse-led hospital-to-home transitional care intervention for older adults with multimorbidity and depressive symptoms: A pragmatic randomized controlled trial. PLoS One. 2021 Jul 26;16(7):e0254573. doi: 10.1371/journal.pone.0254573. eCollection 2021.

    PMID: 34310640DERIVED

  • Markle-Reid M, McAiney C, Ganann R, Fisher K, Gafni A, Gauthier AP, Heald-Taylor G, McElhaney J, Ploeg J, Urajnik DJ, Valaitis R, Whitmore C. Study protocol for a hospital-to-home transitional care intervention for older adults with multiple chronic conditions and depressive symptoms: a pragmatic effectiveness-implementation trial. BMC Geriatr. 2020 Jul 10;20(1):240. doi: 10.1186/s12877-020-01638-0.

    PMID: 32650732DERIVED

Related Links

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Study Officials

  • Maureen F Markle-Reid, Ph.D.

    McMaster University

    PRINCIPAL INVESTIGATOR

  • Carrie McAiney, Ph.D.

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
The Research Assistant who will be collecting the outcome measures will be blinded to group allocation (intervention vs. control) for the duration of data collection.
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: The proposed study design is a pragmatic randomized controlled trial (RCT). A pragmatic design applies RCT methodology in actual care settings to better inform decisions on the likely benefits, harms, and costs of real world implementation. The design is further classified as a Type II hybrid effectiveness-implementation study, which assigns equal weight to assessing program effectiveness and implementation.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Canada Research Chair in Aging, Chronic Disease and Health Promotion Interventions

Study Record Dates

First Submitted

April 12, 2017

First Posted

May 17, 2017

Study Start

July 25, 2017

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

March 23, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(4)