NCT05677997

Brief Summary

The goal of this clinical trial is to test how well resource navigators help long-term care and retirement home staff access the various health and wellness resources available to them and the effects that this has on their health and wellness overall. The main questions it aims to answer are: \- How does one-on-one support from a resource navigator affect the wellness of long-term care and retirement home staff, including burnout, vaccination status, and COVID-19 infection? Researchers will compare participants in the intervention group (where participants are paired with a resource navigator) and the control group (where participants are not paired with a resource navigator) to see the impact access to a resource navigator has on wellness (primary outcome), burnout, knowledge of, access to and use of wellness resources, knowledge/alignment with provincial public health guidelines related to SARS-CoV-2 vaccine outcomes, SARS-CoV-2 infection, hospitalization, and death (secondary outcomes). Hypothesis: Researchers anticipate that those in the intervention group (have access to a resource navigator) will report a higher positive change in wellness between baseline and 6 months.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
174

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2023

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

December 9, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 10, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

March 1, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2025

Completed
Last Updated

December 10, 2024

Status Verified

May 1, 2024

Enrollment Period

2 years

First QC Date

December 9, 2022

Last Update Submit

December 9, 2024

Conditions

Keywords

CaregiverPersonal support workerlong term care homemental health

Outcome Measures

Primary Outcomes (1)

  • Rate of Change in Wellness

    Participant wellness will be assessed using the Personal Wellbeing Score. Survey includes 5 questions and will be scored on a scale from 0 to 16, where 16 is the worst outcome, or poorest level of wellness. For ONS4 life satisfaction, worthwhile and happiness scores, responses 9-10 are grouped as Very high, 7-8 as High, 5-6 as Medium and 0-4 as Low. For anxiety scores, responses 6-10 are grouped as High, 4-5 as Medium, 2-3 as Low and 0-1 as Very low.

    Baseline, and 6 months.

Secondary Outcomes (3)

  • Rate of Change in Level of Burnout

    Baseline, and 6 months.

  • Rate of Changes in knowledge, access to and use of wellness supports,

    Baseline, and 6 months.

  • Rate Changes in number of participants with COVID-19 vaccination, number of participants with COVID infection and hospitalization, over time

    Baseline, and 6 months.

Study Arms (2)

Control

NO INTERVENTION

Receiving monthly resources only

Intervention Group

EXPERIMENTAL

Receiving sessions with a resource navigator 2x a month, and monthly resources.

Behavioral: Intervention

Interventions

InterventionBEHAVIORAL

Sessions to go through goals, problem areas, areas they want to improve.

Intervention Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A fulltime or part-time employee aged 18 years and older identified as a Long-Term Care and Retirement Home staff (PSW's and other support service staff in those in nutrition, housekeeping and laundry)
  • Work in an Ontario Long-term care or retirement home;
  • Comfortable speaking and reading English; and
  • Access to and willingness to use email for study communications

You may not qualify if:

  • Do not identify as or are not employed as a PSW and other support service staff;
  • Do not work in an Ontario long-term care or retirement home;
  • Uncomfortable speaking or reading English; and
  • Do not have access to or unwillingness to use email for study communications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Michaels Hospital,

Toronto, Ontario, M5B 1W8, Canada

RECRUITING

Related Publications (14)

  • Michie S, van Stralen MM, West R. The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci. 2011 Apr 23;6:42. doi: 10.1186/1748-5908-6-42.

    PMID: 21513547BACKGROUND
  • Rios P, Radhakrishnan A, Thomas SM, Darvesh N, Straus SE, Tricco AC. Preventing respiratory illness in older adults aged 60 years and above living in long-term care. MedRxiv. 2020; 1-25. https://doi.org/10.1101/2020.03.19.20039081

    BACKGROUND
  • Rios P, Radhakrishnan A, Williams C, Ramkissoon N, Pham B, Cormack GV, Grossman MR, Muller MP, Straus SE, Tricco AC. Preventing the transmission of COVID-19 and other coronaviruses in older adults aged 60 years and above living in long-term care: a rapid review. Syst Rev. 2020 Sep 25;9(1):218. doi: 10.1186/s13643-020-01486-4.

    PMID: 32977848BACKGROUND
  • IPAC+ Self-Assessment for Long-term Care Facilities (LTCHs) and Retirement Homes (RHs). https://ipac.knowledgetranslation.ca/. Accessed 2021 Feb 18.

    BACKGROUND
  • IPAC+ Resource Library. Regional Geriatric Program of Toronto. https://www.rgptoronto.ca/resources/ipac+/. Updated 2021.

    BACKGROUND
  • Mental Health and COVID-19. Centre for Addiction and Mental Health (CAMH). https://www.camh.ca/en/health-info/mental-health-and-covid-19/information-for-professionals. Published 2020.

    BACKGROUND
  • Mental Health Supports. Wellness HUB Support for Congregate Living Centres. https://wellness-hub.ca/tag/mental-health-supports/. Published 2021.

    BACKGROUND
  • Wraparound Resources Package. Wellness Hub. https://wellness-hub.ca/res/wraparound-resources-package/. Published 2021.

    BACKGROUND
  • Caregiver Resources. The Ontario Caregiver Organization. https://ontariocaregiver.ca/resources-education/caregiver-resources/#caring-for-yourself. Published 2021.

    BACKGROUND
  • What you need to know about getting the COVID-19 vaccine. Wellness Hub. https://wellness-hub.ca/res/what-you-need-to-know-about-getting-the-covid-19-vaccine/. Published 2021.

    BACKGROUND
  • February 2nd, 2021 OPSWA Town Hall #2: COVID vaccine questions answered. Knowledge Translation Program. https://www.youtube.com/watch?v=UCzRgtbHFFQ&t=517s. Published 2021 Mar 31.

    BACKGROUND
  • March 23rd, 2021 OPSWA Town Hall #3: Get you COVID vaccine questions answered. Knowledge Translation Program. https://www.youtube.com/watch?v=hNrNsTXKGT8&t=3s. Published 2021 Mar 26.

    BACKGROUND
  • Knowledge Translation Program. COVID-19 Knowledge Translation. https://knowledgetranslation.net/expertise/covid-19/. Updated 2021.

    BACKGROUND
  • COVID-19 Immunity Task Force. Pan-Canadian studies investigate why COVID-19 has been devastating to long-term care facility residents and staff.

    BACKGROUND

MeSH Terms

Conditions

Caregiver BurdenBurnout, ProfessionalCOVID-19Vaccination RefusalPsychological Well-Being

Interventions

Methods

Condition Hierarchy (Ancestors)

Stress, PsychologicalBehavioral SymptomsBehaviorOccupational StressOccupational DiseasesBurnout, PsychologicalPneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesTreatment RefusalTreatment Adherence and ComplianceHealth BehaviorPersonal Satisfaction

Intervention Hierarchy (Ancestors)

Investigative Techniques

Central Study Contacts

Sharon Sharon Straus, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2022

First Posted

January 10, 2023

Study Start

March 1, 2023

Primary Completion

March 1, 2025

Study Completion

March 1, 2025

Last Updated

December 10, 2024

Record last verified: 2024-05

Locations