Study Stopped
Due to COVID-related issues had to change study design.
Better Together: Reablement and Caregivers
B2G
Out and About: Reablement for Older Adults in the Hospital Setting
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Hospitalization creates opportunities for older adults to accumulate prolonged periods of sitting and lying (defined as sedentary behavior) which can result in mobility loss. We propose a Type 1 Hybrid Effectiveness-Implementation Trial with 1:1 randomization to test the effect of a caregiver intervention on older patients' physical activity at 3 months (home). We will recruit 61 patients and family caregivers from hospital units and follow them for 3 months; the primary outcome is patients' daily step count at 3 months.
Trial Health
Trial Health Score
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Started Apr 2023
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 6, 2020
CompletedFirst Posted
Study publicly available on registry
July 13, 2020
CompletedStudy Start
First participant enrolled
April 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 26, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 26, 2023
CompletedApril 28, 2023
April 1, 2023
Same day
July 6, 2020
April 26, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Veterans Rand-12 Quality of Life
12 item quality of life survey
baseline and 3 months
Secondary Outcomes (12)
Daily minutes sedentary behavior
baseline to 3 months
Daily minutes of physical activity
baseline to 3 months
Patient Assessment with Chronic Illness Care Survey
3 months
Brief Action Planning (BAP)
baseline and 3 months
Action Plans behaviors
baseline and 3 months
- +7 more secondary outcomes
Other Outcomes (5)
Steps per day
baseline to 3 months
Falls
baseline to 3 months
Falls Efficacy Scale International (FES-I)
baseline and 3 months
- +2 more other outcomes
Study Arms (2)
Intervention
EXPERIMENTALUsual Care
ACTIVE COMPARATORInterventions
Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active. Caregiver participants in the intervention group will receive up to six telephone or video calls with the research assistant or Clinical Resource Therapist. Sessions will review the knowledge translation (KT) product with family members (\~15 minutes), art goals, brainstorm strategies, and discuss setbacks. The calls with the caregiver may occur 1 to 2 times in the hospital, within one week of going home, and then in Months 2 and 3.
Patient and caregiver dyads from both groups will receive usual care during hospitalization and following discharge. This will include a handout on strategies for safely remaining active.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The University of British Columbia
Vancouver, British Columbia, V6T1Z3, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 6, 2020
First Posted
July 13, 2020
Study Start
April 26, 2023
Primary Completion
April 26, 2023
Study Completion
April 26, 2023
Last Updated
April 28, 2023
Record last verified: 2023-04
Data Sharing
- IPD Sharing
- Will not share