Better Together: Reablement and Caregivers

Physical Activity Clinical Trial

— B2G  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04467814
• Other study ID #: H20-01612
• Status: Withdrawn
• Phase: N/A
• Start date: April 26, 2023
• Est. completion date: April 26, 2023

Study information

• Verified date: April 2023
• Source: University of British Columbia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 26, 2023
• Est. primary completion date: April 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Caregiver
• Older Adults
• Physical Activity
• Sedentary Behavior

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.
• 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.

Locations

Country	Name	City	State
Canada	The University of British Columbia	Vancouver	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Steps per day	activity monitor	baseline to 3 months
Other	Falls	monthly falls diary	baseline to 3 months
Other	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
Other	Brief Test of Adult Cognition by Telephone	cognitive test	baseline and 3 months
Other	Unified Theory of Acceptance and Use of Technology 2 Survey	self-report questions on perceptions of using technology	baseline and 3 months
Primary	Veterans Rand-12 Quality of Life	12 item quality of life survey	baseline and 3 months
Secondary	Daily minutes sedentary behavior	daily minutes of sedentary behavior measured with an activity monitor	baseline to 3 months
Secondary	Daily minutes of physical activity	daily minutes of physical activity measured with an activity monitor	baseline to 3 months
Secondary	Patient Assessment with Chronic Illness Care Survey	20-item survey with questions related to experience with hospitalization.	3 months
Secondary	Brief Action Planning (BAP)	Goal setting	baseline and 3 months
Secondary	Action Plans behaviors	self-reported health behavior questions	baseline and 3 months
Secondary	Coping Plans	self-reported health behavior questions	baseline and 3 months
Secondary	Physical Activity Intentions	self-reported health behavior questions	baseline and 3 months
Secondary	Physical Activity Self-efficacy	self-reported health behavior questions	baseline and 3 months
Secondary	Physical Activity Risk Perceptions	self-reported health behavior questions	baseline and 3 months
Secondary	Physical Activity Outcome Expectancies	self-reported health behavior questions	baseline and 3 months
Secondary	Self-reported Habit Index	self-reported health behavior questions	baseline and 3 months
Secondary	Program implementation	Semi-structured interviews or focus groups with patients, caregivers, and heath providers to understand factors related program implementation.	baseline and 3 months