NCT04467814

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

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 6, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 13, 2020

Completed
2.8 years until next milestone

Study Start

First participant enrolled

April 26, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2023

Completed
Last Updated

April 28, 2023

Status Verified

April 1, 2023

Enrollment Period

Same day

First QC Date

July 6, 2020

Last Update Submit

April 26, 2023

Conditions

Keywords

caregiver, patient, e-Course

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

EXPERIMENTAL
Behavioral: Better Together

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Care

Interventions

Better TogetherBEHAVIORAL

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.

Intervention
Usual CareBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of British Columbia

Vancouver, British Columbia, V6T1Z3, Canada

Location

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior
0

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

Locations