Disability PhysicalCAPABLE-VNSNYNCT03456128
Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention
A study testing CAPABLE in people with Disability Physical, run by Johns Hopkins University at 1 site in United States.
Trial summary
This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Disability Physical
- What is being tested?
- CAPABLE
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 268 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2018to 30 Sep 2025
- 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 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Aged ≥ 65 years old;
- Are 60 days post-hospitalization in an acute care setting and have had a Visiting Nurse Service of New York (VNSNY) visit;
- Have difficulty with at least one activity of daily living (ADL);
- Are a member of the VNSNY CHOICE Medicare Advantage Health Plan;
- Are able to stand with or without assistance; and
- Are available during the intervention period
Who cannot join
- Have significant cognitive impairment identified by the Callahan screening tool;
- Do not speak English or Spanish;
- Have had more than 3 hospitalizations within the past 12 months;
- Are actively receiving radiation or chemotherapy;
- Have plans to relocate in less than one year;
- Have diagnoses of the following: Dementia, Alzheimer's, Other Cerebral Degeneration, and serious cognitive impairment or OASIS assessment level 3 response on M1034 "serious progressive conditions that could lead to death within a year"
Trial locations and contacts
1 site in 1 country.
United States1 site
Visiting Nurse Service of New York
New York, New York, 10001
About this study
This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization.
Read the detailed description
Currently, there is no evidence-based approach to improve post-hospitalization functional decline. CAPABLE uses a novel inter-professional team involving an occupational therapist, nurse, and handyman to improve ADLs in older adults post-hospitalization.
In a Center for Medicare \& Medicaid Innovation (CMMI) demonstration project, CAPABLE demonstrated a 45% reduction of ADL difficulties in older adults from baseline to five months.The significance of this improvement could make the difference between aging at home independently and relocating to institutional care. While these results are encouraging, CAPABLE needs evaluation in real world health delivery contexts with more ethnic diversity.The purpose of this study is to test the effectiveness of CAPABLE in older adults in an active community health care program.
Interventions: CAPABLE Intervention: Participants in the treatment group will receive up to 10 in-home sessions (≤6 visits with an occupational therapist and ≤4 visits from a nurse)-and up to $1500 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component (education, assessment, and identification of functional goals, specific strategies tailored to goals and based on protocols). Usual Care Group: Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. After baseline, all study participants will be reassessed at 20 weeks and possibly a third interview at 52 weeks. Assessments will be completed by a research assistant masked to treatment condition.
- Conditions
- Disability Physical
- Being tested
- CAPABLE
- Keywords
- Older Adult, Rehospitalization, Physical function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAPABLEOther
It involves up to 10 in-home tailored interventions of approximately 60 minutes duration each over a 5-month period. The assessment driven interventions are delivered by an Occupational Therapist (OT) (≤ 6 home visits for ≤ 1hour), a Registered Nurse (RN) (≤ 4 home visits for ≤ 1hour), and a handyman (HM) team.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The experimental group will receive CAPABLE services. These include ≤10 sessions: ≤ 6 with an Occupational Therapist (OT) and ≤ 4 sessions with a Registered Nurse (RN) and up to ≤ $1,500 of home safety and home modifications from a licensed handyman who is guided by the OT. The OT and RN sessions will target participants' self-identified functional goals (e.g., getting safely into the tub, getting upstairs to sleep in own bed). Receives: Other: CAPABLE |
| Usual Care | No intervention | Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean ADL Difficulty Score
Change in ADL- the range is 0 - 16, with higher scores indicating that the participant needs a lot of help with performing many ADLs (is more disabled) and lower scores indicating that the participant is not disabled
Measured: 20-week follow-up period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Mar 2018
- Study start25 Aug 2018
- Primary completion11 Sep 2023
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disability PhysicalStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Model description
- The study is a single-masked, two-group, randomized trial to test the effectiveness of CAPABLE in reducing ADL difficulties compared to those randomized to usual care.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor
- Investigators
- Sarah L. Szanton, PhD, RN, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03456128
- Sponsor's protocol ID
- IRB00141968
- Other IDs
- 1R01AG056607-01
- Acronym
- CAPABLE-VNSNY
- Status last verified
- Oct 2025
- First submitted
- 3 Jan 2018
- Last updated
- 15 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reducing Disability Following Hospital Discharge in Vulnerable Older Adults: The CAPABLE Intervention
- ClinicalTrials.gov ID
- NCT03456128
- Acronym / sponsor ID
- CAPABLE-VNSNY / IRB00141968
- Conditions
- Disability Physical
- Keywords
- Older Adult, Rehospitalization, Physical function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 25 Aug 2018 (actual)
- Primary completion
- 11 Sep 2023 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 7 Mar 2018 (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.
This study evaluates whether the utilization of integrated health services such as help with medications, muscle strengthening, balance training, pain management and home modification interventions can help improve older adults' ability to sleep, balance, walk, and take care of themselves after hospitalization.
Detailed description
Currently, there is no evidence-based approach to improve post-hospitalization functional decline. CAPABLE uses a novel inter-professional team involving an occupational therapist, nurse, and handyman to improve ADLs in older adults post-hospitalization.
In a Center for Medicare \& Medicaid Innovation (CMMI) demonstration project, CAPABLE demonstrated a 45% reduction of ADL difficulties in older adults from baseline to five months.The significance of this improvement could make the difference between aging at home independently and relocating to institutional care. While these results are encouraging, CAPABLE needs evaluation in real world health delivery contexts with more ethnic diversity.The purpose of this study is to test the effectiveness of CAPABLE in older adults in an active community health care program.
Interventions: CAPABLE Intervention: Participants in the treatment group will receive up to 10 in-home sessions (≤6 visits with an occupational therapist and ≤4 visits from a nurse)-and up to $1500 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component (education, assessment, and identification of functional goals, specific strategies tailored to goals and based on protocols). Usual Care Group: Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. After baseline, all study participants will be reassessed at 20 weeks and possibly a third interview at 52 weeks. Assessments will be completed by a research assistant masked to treatment condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study is a single-masked, two-group, randomized trial to test the effectiveness of CAPABLE in reducing ADL difficulties compared to those randomized to usual care.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: CAPABLEThe experimental group will receive CAPABLE services. These include ≤10 sessions: ≤ 6 with an Occupational Therapist (OT) and ≤ 4 sessions with a Registered Nurse (RN) and up to ≤ $1,500 of home safety and home modifications from a licensed handyman who is guided by the OT. The OT and RN sessions will target participants' self-identified functional goals (e.g., getting safely into the tub, getting upstairs to sleep in own bed). |
| Usual Care | No intervention | –Participants in the usual care group will not receive visit from study clinicians and will continue to receive their usual VNSNY CHOICE benefits and healthcare. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (6 listed)
- Aged ≥ 65 years old;
- Are 60 days post-hospitalization in an acute care setting and have had a Visiting Nurse Service of New York (VNSNY) visit;
- Have difficulty with at least one activity of daily living (ADL);
- Are a member of the VNSNY CHOICE Medicare Advantage Health Plan;
- Are able to stand with or without assistance; and
Key exclusion criteria (6 listed)
- Have significant cognitive impairment identified by the Callahan screening tool;
- Do not speak English or Spanish;
- Have had more than 3 hospitalizations within the past 12 months;
- Are actively receiving radiation or chemotherapy;
- Have plans to relocate in less than one year;
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 |
|---|---|---|
| CAPABLEIt involves up to 10 in-home tailored interventions of approximately 60 minutes duration each over a 5-month period. The assessment driven interventions are delivered by an Occupational Therapist (OT) (≤ 6 home visits for ≤ 1hour), a Registered Nurse (RN) (≤ 4 home visits for ≤ 1hour), and a handyman (HM) team. | Other | Intervention |
Primary outcome
Mean ADL Difficulty Score
Time frame: 20-week follow-up period
Change in ADL- the range is 0 - 16, with higher scores indicating that the participant needs a lot of help with performing many ADLs (is more disabled) and lower scores indicating that the participant is not disabled
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2025.
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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.
Sarah L. Szanton, PhD, RN principal investigator
Johns Hopkins University
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 in people with Disability Physical, run by Johns Hopkins University 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 6 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 15 Oct 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean ADL Difficulty Score (time frame: 20-week follow-up period). 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 15 Oct 2025.