Care TransitionsNCT04460742
CAPABLE Transitions: A Home Health-Based Intervention for the Hospital or Post-Acute Care Facility-to-Home Transition
A study testing CAPABLE Transitions and Home Health Agency Care in people with Care Transitions and Dementia, run by University of Rochester at 1 site in United States.
Trial summary
This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Care Transitions, Dementia
- What is being tested?
- CAPABLE Transitions and Home Health Agency Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Mar 2021to 19 May 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- admitted to Medicare-certified home health agency following discharge from a hospital, inpatient rehabilitation facility, or skilled nursing facility
- live in Rochester, NY region
- aged 65 years or older
- English-speaking
Who cannot join
- plan to move within one year
- has a terminal diagnosis (e.g., < 1-year life expectancy, in hospice)
- receiving active cancer treatment (active treatment includes surgery or a course of radiation or chemotherapy; it does not include long-term maintenance treatment such as daily hormonal treatment of prostate cancer)
- inability or unwillingness of individual or legal guardian/representative to give written informed consent or assent
- has been discharged from a hospital or post-acute care facility for more than 28 days
- are COVID-19 positive, have suspected COVID-19 infection, or resides with a person who is COVID-19 positive or has suspected COVID-19
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: CAPABLE Transitions: A Randomized, Unblinded, 60-Subject Clinical Trial of an Occupational Therapy-Led In-Home Intervention to Help Older Adults Transition to Their Homes Following Hospital or Post-Acute Care Facility Discharge
This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from a hospital or post-acute care facility discharge as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a hospital or post-acute care facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.
Read the detailed description
This pilot study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of an occupational therapy (OT)-led in-home intervention designed to help older adults successfully return to and remain in their homes following discharge from a hospital or post-acute care facility (e.g., skilled nursing or inpatient rehabilitation facilities). This intervention is called CAPABLE Transitions. In total, 60 adults (36 in the intervention arm, 24 in the CAU arm) aged 65 years and older recently discharged from a hospital or post-acute care facility and admitted to a Medicare-certified home health agency (CHHA) with and without dementia will be recruited. This pilot study's main outcomes relate to the feasibility of the study. These outcomes include study recruitment and retention, fidelity to and perceived benefit of the intervention, and data completeness with regard to clinical outcomes (e.g., home time, quality of life, and health care utilization).
This study will recruit English-speaking adults aged 65 years and older who live in the Rochester region and are admitted to a CHHA following a hospital or post-acute care facility stay. There are two treatment groups. The intervention group will receive CAPABLE Transitions as well as CHHA CAU services. The CAU group will receive CHHA CAU services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. CHHA clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
Assessment interviews will be conducted at baseline as well as at three and six month follow-up. Interviews will assess sociodemographics, health and functioning, mental health and cognitive functioning, home environment, medical services use, and intervention feedback. Information also will be extracted on medical conditions, medications, communication with providers, and services utilization from participants' medical records.
- Conditions
- Care Transitions, Dementia
- Being tested
- CAPABLE Transitions, Home Health Agency Care
- Keywords
- Post-acute care, Home health agency
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLE TransitionsBehavioural
The CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (<6 visits), registered nurse (<5 visits), and handyman (<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis.
Home Health Agency CareBehavioural
Both the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
| Study group | Role | What they receive |
|---|---|---|
| CAPABLE Transitions | Experimental | Older adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months. Receives: Behavioral: CAPABLE Transitions; Behavioral: Home Health Agency Care |
| Care As Usual | Active comparator | Older adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual. Receives: Behavioral: Home Health Agency Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Screened as Eligible
The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Measured: For each potential participant, this outcome is determined prior to possible study enrollment.
Percentage of Screened Participants That Enroll
The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
Measured: This outcome is determined at the time of study enrollment.
Percentage of Enrolled Participants That Are Retained
The study will monitor the percentage of participants that complete the study.
Measured: 6 months
Percentage of Participants Who Perceive a Benefit From the Intervention
Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Measured: 3 months
Percentage of Participants Who Perceive a Benefit From the Intervention
Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Measured: 6 months
Proportion of Critical Tasks Completed
The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.
Measured: Throughout Study Intervention, an average of 5 months
Data Completeness on Clinical Outcomes
The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.
Measured: 3 months
Data Completeness on Clinical Outcomes
The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.
Measured: 6 months
Secondary outcomes (8)
Home Time in Days (From the Baseline to 3 Month Period)
Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from baseline to 3 months of follow-up.
Measured: Baseline to Month 3 (3 months)
Home Time in Days (From the 3 to 6 Month Period)
Home time is the number of days participants spend alive in non-institutional settings (e.g., nursing homes and hospitals). The study will report the participants' home time from 3 to 6 months of follow-up.
Measured: Month 3 to Month 6 (3 months)
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
The study will examine quality of life (EQ-5D-5L) among study participants at 3 months of follow-up (positive scores indicate improvement from baseline).
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
Measured: 3 months
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
The study will examine quality of life (EQ-5D-5L) among study participants at 6 months of follow-up (positive scores indicate improvement from baseline).
Rating: mobility, self-care, usual activities, pain/discomfort and anxiety/depression, each with 1 as lowest score and 5 as highest score: no problems, slight problems, moderate problems, severe problems and extreme problems, where higher scores indicate worse outcome.
The EQ VAS question records the patient's self-rated health on a vertical visual analogue scale from 0 to 100, where the endpoints are labelled 'The best health you can imagine' (score=100) and 'The worst health you can imagine' (score=0). Therefore higher scores may indicate better outcomes.
Measured: 6 months
Health Services Use, Percentage
The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
Measured: Baseline to Month 3 (3 months)
Health Services Use, Percentage
The study will examine the percentage of participants who went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
Measured: Month 3 to Month 6 (3 months)
Health Services Use, Mean
The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from baseline to 3 months of follow-up.
Measured: Baseline to Month 3 (3 months)
Health Services Use, Mean
The study will tabulate the mean number of times participants went to the emergency department, were hospitalized, and were admitted to a skilled nursing facility from 3 to 6 months of follow-up.
Measured: Month 3 to Month 6 (3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2020
- Study start18 Mar 2021
- Primary completion19 May 2023
- Study completion19 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Care TransitionsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe 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
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Adam Simning, University of Rochester
- Investigators
- Adam Simning, MD, PhD, Principal investigator, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04460742
- Sponsor's protocol ID
- STUDY00004519
- Other IDs
- 5K23AG058757-02, 3 K 23 AG058757-02S1
- Status last verified
- Jul 2023
- First submitted
- 26 Jun 2020
- Last updated
- 1 Aug 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared upon request as part of a academic collaboration
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPABLE Transitions: A Randomized, Unblinded, 60-Subject Clinical Trial of an Occupational Therapy-Led In-Home Intervention to Help Older Adults Transition to Their Homes Following Hospital or Post-Acute Care Facility Discharge
- ClinicalTrials.gov ID
- NCT04460742
- Acronym / sponsor ID
- STUDY00004519
- Conditions
- Care Transitions, Dementia
- Keywords
- Post-acute care, Home health agency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 18 Mar 2021 (actual)
- Primary completion
- 19 May 2023 (actual)
- Study completion
- 19 May 2023 (actual)
- First posted
- 8 Jul 2020 (actual)
- Results
- Posted 1 Aug 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical study is designed to test the feasibility of a new intervention, CAPABLE Transitions. CAPABLE Transitions is based on the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) intervention designed by Dr. Sarah Szanton at Johns Hopkins University. Similar to CAPABLE, CAPABLE Transitions consists of an occupational therapy (OT)-led intervention in which the study OT, nurse, and handyman deliver an in-home intervention over 3-4 months. This intervention is designed to help with the transition of care from a hospital or post-acute care facility discharge as well as to optimize functioning and home safety. This clinical study plans to recruit a total of 60 older adults with and without dementia admitted to a home health agency following discharge from a hospital or post-acute care facility. Given that this is a feasibility study, it is not designed or powered to test hypotheses.
Detailed description
This pilot study is a randomized, care-as-usual (CAU)-comparator, unblinded clinical trial of an occupational therapy (OT)-led in-home intervention designed to help older adults successfully return to and remain in their homes following discharge from a hospital or post-acute care facility (e.g., skilled nursing or inpatient rehabilitation facilities). This intervention is called CAPABLE Transitions. In total, 60 adults (36 in the intervention arm, 24 in the CAU arm) aged 65 years and older recently discharged from a hospital or post-acute care facility and admitted to a Medicare-certified home health agency (CHHA) with and without dementia will be recruited. This pilot study's main outcomes relate to the feasibility of the study. These outcomes include study recruitment and retention, fidelity to and perceived benefit of the intervention, and data completeness with regard to clinical outcomes (e.g., home time, quality of life, and health care utilization).
This study will recruit English-speaking adults aged 65 years and older who live in the Rochester region and are admitted to a CHHA following a hospital or post-acute care facility stay. There are two treatment groups. The intervention group will receive CAPABLE Transitions as well as CHHA CAU services. The CAU group will receive CHHA CAU services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. CHHA clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study.
Assessment interviews will be conducted at baseline as well as at three and six month follow-up. Interviews will assess sociodemographics, health and functioning, mental health and cognitive functioning, home environment, medical services use, and intervention feedback. Information also will be extracted on medical conditions, medications, communication with providers, and services utilization from participants' medical records.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAPABLE Transitions | Experimental | Behavioral: CAPABLE Transitions, Behavioral: Home Health Agency CareOlder adults admitted to University of Rochester Medicine Home Care with and without dementia will receive care as usual as well as CAPABLE-trained occupational therapy, registered nurse, and handyman services delivered over 3-4 months. |
| Care As Usual | Active comparator | Behavioral: Home Health Agency CareOlder adults admitted to University of Rochester Medicine Home Care (a Medicare-certified home health agency) with and without dementia will receive care as usual. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- admitted to Medicare-certified home health agency following discharge from a hospital, inpatient rehabilitation facility, or skilled nursing facility
- live in Rochester, NY region
- aged 65 years or older
- English-speaking
Key exclusion criteria (6 listed)
- plan to move within one year
- has a terminal diagnosis (e.g., < 1-year life expectancy, in hospice)
- receiving active cancer treatment (active treatment includes surgery or a course of radiation or chemotherapy; it does not include long-term maintenance treatment such as daily hormonal treatment of prostate cancer)
- inability or unwillingness of individual or legal guardian/representative to give written informed consent or assent
- has been discharged from a hospital or post-acute care facility for more than 28 days
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 |
|---|---|---|
| CAPABLE TransitionsThe CAPABLE Transitions intervention group will receive an occupational therapy-led multidisciplinary in-home intervention in which the study occupational therapist (<6 visits), registered nurse (<5 visits), and handyman (<2 visits) work with participants over 3-4 months. This intervention group also will receive home health agency care as usual services. CAPABLE Transitions in embedded within a home health agency and includes a care transitions emphasis. | Behavioural | CAPABLE Transitions |
| Home Health Agency CareBoth the CAPABLE Transitions intervention and care as usual treatment arms will receive home health agency care as usual services, which can include nursing, health aide, medical social work, and occupational, physical, and speech therapy services. Home health agency clinicians will determine the types and duration of CHHA services that the study participants receive; these services will be completely independent from the research study. | Behavioural | CAPABLE Transitions, Care As Usual |
Primary outcome
Percentage of Participants Screened as Eligible
Time frame: For each potential participant, this outcome is determined prior to possible study enrollment.
The study will monitor how many older adults are screened and satisfy the eligibility criteria.
Percentage of Screened Participants That Enroll
Time frame: This outcome is determined at the time of study enrollment.
The study will monitor how many older adults who satisfy the eligibility criteria are enrolled in the study.
Percentage of Enrolled Participants That Are Retained
Time frame: 6 months
The study will monitor the percentage of participants that complete the study.
Percentage of Participants Who Perceive a Benefit From the Intervention
Time frame: 3 months
Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Percentage of Participants Who Perceive a Benefit From the Intervention
Time frame: 6 months
Participants and study partners will be asked Likert-item response survey questions to assess the perceived benefit and burdensomeness of the intervention.
Proportion of Critical Tasks Completed
Time frame: Throughout Study Intervention, an average of 5 months
The study will review audio recordings and study interventionists' documentation to examine fidelity to the intervention and score whether the interventionists completed the central tasks of CAPABLE Transitions. The study will score completion of the critical components as "yes" or "no" and this outcome will be reported as the proportion of critical components of the CAPABLE Transitions intervention that were completed by the occupational therapist and registered nurse.
Data Completeness on Clinical Outcomes
Time frame: 3 months
The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 3 months.
Data Completeness on Clinical Outcomes
Time frame: 6 months
The study will monitor the percentage of participants who have complete information on home time, quality of life, and health services utilization at 6 months.
8 secondary outcomes
Home Time in Days (From the Baseline to 3 Month Period)
Time frame: Baseline to Month 3 (3 months)
Home Time in Days (From the 3 to 6 Month Period)
Time frame: Month 3 to Month 6 (3 months)
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Time frame: 3 months
Mean Change in Quality of Life Using EQ-5D-5L (Unabbreviated Title)
Time frame: 6 months
Health Services Use, Percentage
Time frame: Baseline to Month 3 (3 months)
Health Services Use, Percentage
Time frame: Month 3 to Month 6 (3 months)
Health Services Use, Mean
Time frame: Baseline to Month 3 (3 months)
Health Services Use, Mean
Time frame: Month 3 to Month 6 (3 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. IPD will be shared upon request as part of a academic collaboration
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Optimizing Care Transitions in CHD
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Recruiting
I-SLEPT: Integrated Sleep and Life Engagement Program for Transitions
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Diabetes Toolkit at Discharge
Diabetes Mellitus, Type 2, Insulin Dependent Diabetes
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.
Adam Simning, MD, PhD principal investigator
University of Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CAPABLE Transitions and Home Health Agency Care in people with Care Transitions and Dementia, run by University of Rochester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. 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: finished, as of the sponsor's last update on 1 Aug 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 United States. 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?
Yes. Results are posted in the registry (first posted 1 Aug 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Participants Screened as Eligible (time frame: For each potential participant, this outcome is determined prior to possible study enrollment.). The study lists 8 primary outcomes in all. 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 1 Aug 2023.