Older AdultsB2GNCT04467814
Better Together: Reablement and Caregivers
A study testing Better Together in people with Older Adults and Sedentary Behavior, run by University of British Columbia at 1 site in Canada.
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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Older Adults, Sedentary Behavior, Physical Activity
- What is being tested?
- Better Together
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- 26 Apr 2023to 26 Apr 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
Canada1 site
The University of British Columbia
Vancouver, British Columbia, V6T1Z3
About this study
Official title: 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.
- Conditions
- Older Adults, Sedentary Behavior, Physical Activity, Caregiver
- Being tested
- Better Together, Usual Care
- Keywords
- caregiver, patient, e-Course
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Better TogetherBehavioural
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 CareBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Not described Receives: Behavioral: Better Together |
| Usual Care | Active comparator | Not described Receives: Behavioral: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Veterans Rand-12 Quality of Life
12 item quality of life survey
Measured: baseline and 3 months
Secondary outcomes (12)
Daily minutes sedentary behavior
daily minutes of sedentary behavior measured with an activity monitor
Measured: baseline to 3 months
Daily minutes of physical activity
daily minutes of physical activity measured with an activity monitor
Measured: baseline to 3 months
Patient Assessment with Chronic Illness Care Survey
20-item survey with questions related to experience with hospitalization.
Measured: 3 months
Brief Action Planning (BAP)
Goal setting
Measured: baseline and 3 months
Action Plans behaviors
self-reported health behavior questions
Measured: baseline and 3 months
Coping Plans
self-reported health behavior questions
Measured: baseline and 3 months
Physical Activity Intentions
self-reported health behavior questions
Measured: baseline and 3 months
Physical Activity Self-efficacy
self-reported health behavior questions
Measured: baseline and 3 months
Physical Activity Risk Perceptions
self-reported health behavior questions
Measured: baseline and 3 months
Physical Activity Outcome Expectancies
self-reported health behavior questions
Measured: baseline and 3 months
Self-reported Habit Index
self-reported health behavior questions
Measured: baseline and 3 months
Program implementation
Semi-structured interviews or focus groups with patients, caregivers, and heath providers to understand factors related program implementation.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2020
- Study start26 Apr 2023
- Primary completion26 Apr 2023
- Study completion26 Apr 2023
Why it stopped: Due to COVID-related issues had to change study design.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Older AdultsStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maureen C. Ashe, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04467814
- Sponsor's protocol ID
- H20-01612
- Acronym
- B2G
- Status last verified
- Apr 2023
- First submitted
- 6 Jul 2020
- Last updated
- 28 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Out and About: Reablement for Older Adults in the Hospital Setting
- ClinicalTrials.gov ID
- NCT04467814
- Acronym / sponsor ID
- B2G / H20-01612
- Conditions
- Older Adults, Sedentary Behavior, Physical Activity, Caregiver
- Keywords
- caregiver, patient, e-Course
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID-related issues had to change study design.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- 26 Apr 2023 (actual)
- Primary completion
- 26 Apr 2023 (actual)
- Study completion
- 26 Apr 2023 (actual)
- First posted
- 13 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Behavioral: Better Together |
| Usual Care | Active comparator | Behavioral: Usual Care |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Better TogetherPatient 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. | Behavioural | Intervention |
| Usual CarePatient 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. | Behavioural | Usual Care |
Primary outcome
Veterans Rand-12 Quality of Life
Time frame: baseline and 3 months
12 item quality of life survey
12 secondary outcomes
Daily minutes sedentary behavior
Time frame: baseline to 3 months
Daily minutes of physical activity
Time frame: baseline to 3 months
Patient Assessment with Chronic Illness Care Survey
Time frame: 3 months
Brief Action Planning (BAP)
Time frame: baseline and 3 months
Action Plans behaviors
Time frame: baseline and 3 months
Coping Plans
Time frame: baseline and 3 months
Physical Activity Intentions
Time frame: baseline and 3 months
Physical Activity Self-efficacy
Time frame: baseline and 3 months
Physical Activity Risk Perceptions
Time frame: baseline and 3 months
Physical Activity Outcome Expectancies
Time frame: baseline and 3 months
Self-reported Habit Index
Time frame: baseline and 3 months
Program implementation
Time frame: baseline and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Better Together in people with Older Adults and Sedentary Behavior, run by University of British Columbia at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Veterans Rand-12 Quality of Life (time frame: baseline and 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Apr 2023.