Better Together: Reablement and Caregivers (B2G)

Out and About: Reablement for Older Adults in the Hospital Setting

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.

Study Overview

• Status: Withdrawn
• Conditions: Physical Activity; Sedentary Behavior; Older Adults; Caregiver
• Intervention / Treatment: Behavioral: Better Together; Behavioral: Usual Care

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T1Z3
      • The University of British Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria: Older adults (60 years and older) with a recent hospitalization and their caregiver.

Exclusion Criteria: Caregivers and older adults with a dementia diagnosis, head injury, significant neurological impairment, or receive treatment for medical conditions that preclude exercising.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention	Behavioral: Better Together; 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.
Active Comparator: Usual Care	Behavioral: Usual Care; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Veterans Rand-12 Quality of Life	12 item quality of life survey	baseline and 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily minutes sedentary behavior	daily minutes of sedentary behavior measured with an activity monitor	baseline to 3 months
Daily minutes of physical activity	daily minutes of physical activity measured with an activity monitor	baseline to 3 months
Patient Assessment with Chronic Illness Care Survey	20-item survey with questions related to experience with hospitalization.	3 months
Brief Action Planning (BAP)	Goal setting	baseline and 3 months
Action Plans behaviors	self-reported health behavior questions	baseline and 3 months
Coping Plans	self-reported health behavior questions	baseline and 3 months
Physical Activity Intentions	self-reported health behavior questions	baseline and 3 months
Physical Activity Self-efficacy	self-reported health behavior questions	baseline and 3 months
Physical Activity Risk Perceptions	self-reported health behavior questions	baseline and 3 months
Physical Activity Outcome Expectancies	self-reported health behavior questions	baseline and 3 months
Self-reported Habit Index	self-reported health behavior questions	baseline and 3 months
Program implementation	Semi-structured interviews or focus groups with patients, caregivers, and heath providers to understand factors related program implementation.	baseline and 3 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Steps per day	activity monitor	baseline to 3 months
Falls	monthly falls diary	baseline to 3 months
Falls Efficacy Scale International (FES-I)	16 questions related to falls self-efficacy. Scoring: minimum 16 (no falling concerns) to maximum 64 (high falling concern)	baseline and 3 months
Brief Test of Adult Cognition by Telephone	cognitive test	baseline and 3 months
Unified Theory of Acceptance and Use of Technology 2 Survey	self-report questions on perceptions of using technology	baseline and 3 months

Collaborators and Investigators

• Sponsor: University of British Columbia

Study record dates

Study Major Dates

• Study Start (Actual): April 26, 2023
• Primary Completion (Actual): April 26, 2023
• Study Completion (Actual): April 26, 2023

Study Registration Dates

• First Submitted: July 6, 2020
• First Submitted That Met QC Criteria: July 8, 2020
• First Posted (Actual): July 13, 2020

Study Record Updates

• Last Update Posted (Actual): April 28, 2023
• Last Update Submitted That Met QC Criteria: April 26, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: caregiver, patient, e-Course
• Other Study ID Numbers: H20-01612

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No