Muscle WeaknessCAPABLE500NCT01743495
CAPABLE for Frail Dually Eligible Older Adults
A study testing 10 home-based functional services sessions over 4 months. in people with Muscle Weakness, run by Johns Hopkins University at 1 site in United States.
Trial summary
The Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Muscle Weakness
- What is being tested?
- 10 home-based functional services sessions over 4 months.
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 281 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to 31 Aug 2019
- 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
- No healthy volunteers
- Older adult
Who may be able to join
- 65 or older
- Cognitively intact (≥ 10 on Brief Interview of Mental Status)
- Difficulty with ≥ 2 IADLS or ≥ 1 ADL
- ≤ 199% of Federal Poverty level
Who cannot join
- Terminally ill
- --Active cancer treatment
- Hospitalized > 3 times in last 3 years
- Receiving home nursing, Occupational Therapy or Physical Therapy
- Don't have phone or do plan to move in less than a year
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins University School of Nursing
Baltimore, Maryland, 21205
About this study
The Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.
Read the detailed description
- 65yrs or older
- Be able to stand (with or without assistance)
- Have some difficulty with getting dressed, or preparing food, bathing
- Receive a low monthly income
- Have no plans to move in the next year
- NOT be receiving home nursing or other therapy right now
- Conditions
- Muscle Weakness
- Being tested
- 10 home-based functional services sessions over 4 months.
- Keywords
- Medical Costs, improved IADLs, and/or ADL's, decreased nursing home admissions
- Medical subject headings
- Muscle Weakness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
10 home-based functional services sessions over 4 months.Behavioural
The program consists of up to 10 home-based functional services sessions over 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Functional Services | Other | The program consists of up to 10 home-based functional services sessions over 4 months. Receives: Behavioral: 10 home-based functional services sessions over 4 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost Effective
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Measured: one year after intervention
Cost Effective
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Measured: two years after intervention
Cost Effective
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Measured: one year after intervention
Cost Effective
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Measured: two years after intervention
Secondary outcomes (6)
Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire
The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.
Measured: four months post intervention
Quality of Life as assessed by the ADL Questionnaire
The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.
Measured: eight months post intervention
Quality of Life as assessed by the ADL Questionnaire
The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.
Measured: twelve months post intervention
Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.
Measured: four months post intervention
Quality of Life as assessed by the IADL Questionnaire
The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.
Measured: eight months post intervention
Quality of Life as assessed by the IADL Questionnaire
The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.
Measured: twelve months post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2012 (estimated)
- Study startSep 2012
- Primary completion31 Aug 2018
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Muscle WeaknessStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 281 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, Baltimore City Health Department
- Responsible party
- Sponsor
- Investigators
- Sarah Szanton, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01743495
- Sponsor's protocol ID
- NA_00076471
- Other IDs
- 1C1CMS330970-01-00
- Acronym
- CAPABLE500
- Status last verified
- Feb 2020
- First submitted
- 15 Oct 2012
- Last updated
- 12 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Szanton SL, Alfonso YN, Leff B, Guralnik J, Wolff JL, Stockwell I, Gitlin LN, Bishai D. Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults. J Am Geriatr Soc. 2018 Mar;66(3):614-620. doi: 10.1111/jgs.15143. Epub 2017 Nov 22.
PubMed 29165789Waldersen BW, Wolff JL, Roberts L, Bridges AE, Gitlin LN, Szanton SL. Functional Goals and Predictors of Their Attainment in Low-Income Community-Dwelling Older Adults. Arch Phys Med Rehabil. 2017 May;98(5):896-903. doi: 10.1016/j.apmr.2016.11.017. Epub 2016 Dec 19.
PubMed 28007445
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAPABLE for Frail Dually Eligible Older Adults
- ClinicalTrials.gov ID
- NCT01743495
- Acronym / sponsor ID
- CAPABLE500 / NA_00076471
- Conditions
- Muscle Weakness
- Keywords
- Medical Costs, improved IADLs, and/or ADL's, decreased nursing home admissions
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 281 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Centers for Medicare and Medicaid Services, Baltimore City Health Department
- Study start
- Sep 2012
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 6 Dec 2012 (estimated)
- 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.
The Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.
Detailed description
- 65yrs or older
- Be able to stand (with or without assistance)
- Have some difficulty with getting dressed, or preparing food, bathing
- Receive a low monthly income
- Have no plans to move in the next year
- NOT be receiving home nursing or other therapy right now
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional Services | Other | Behavioral: 10 home-based functional services sessions over 4 months.The program consists of up to 10 home-based functional services sessions over 4 months. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- 65 or older
- Cognitively intact (≥ 10 on Brief Interview of Mental Status)
- Difficulty with ≥ 2 IADLS or ≥ 1 ADL
- ≤ 199% of Federal Poverty level
Key exclusion criteria (5 listed)
- Terminally ill
- --Active cancer treatment
- Hospitalized > 3 times in last 3 years
- Receiving home nursing, Occupational Therapy or Physical Therapy
- Don't have phone or do plan to move in less than a 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 |
|---|---|---|
| 10 home-based functional services sessions over 4 months.The program consists of up to 10 home-based functional services sessions over 4 months. | Behavioural | Functional Services |
Primary outcome
Cost Effective
Time frame: one year after intervention
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Cost Effective
Time frame: two years after intervention
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
Cost Effective
Time frame: one year after intervention
Chart review to see change between cost of intervention to medicare before and after CAPABALE
Cost Effective
Time frame: two years after intervention
Chart review to see change between cost of intervention to medicare before and after CAPABALE
6 secondary outcomes
Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire
Time frame: four months post intervention
Quality of Life as assessed by the ADL Questionnaire
Time frame: eight months post intervention
Quality of Life as assessed by the ADL Questionnaire
Time frame: twelve months post intervention
Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Time frame: four months post intervention
Quality of Life as assessed by the IADL Questionnaire
Time frame: eight months post intervention
Quality of Life as assessed by the IADL Questionnaire
Time frame: twelve months post intervention
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 12 Feb 2020.
- Derived from this study: PubMed 29165789Szanton SL, Alfonso YN, Leff B, Guralnik J, Wolff JL, Stockwell I, Gitlin LN, Bishai D. Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults. J Am Geriatr Soc. 2018 Mar;66(3):614-620. doi: 10.1111/jgs.15143. Epub 2017 Nov 22.
- Derived from this study: PubMed 28007445Waldersen BW, Wolff JL, Roberts L, Bridges AE, Gitlin LN, Szanton SL. Functional Goals and Predictors of Their Attainment in Low-Income Community-Dwelling Older Adults. Arch Phys Med Rehabil. 2017 May;98(5):896-903. doi: 10.1016/j.apmr.2016.11.017. Epub 2016 Dec 19.
- 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.
Sarah Szanton 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 10 home-based functional services sessions over 4 months. in people with Muscle Weakness, 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 4 inclusion and 5 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 12 Feb 2020. 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?
Cost Effective (time frame: one year after intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01743495, which also lists 2 linked publications.
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 12 Feb 2020; AzTrials last refreshed its copy on 6 Nov 2026.