- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01743495
CAPABLE for Frail Dually Eligible Older Adults (CAPABLE500)
10. februar 2020 oppdatert av: Johns Hopkins University
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
- 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
Studietype
Intervensjonell
Registrering (Faktiske)
281
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Maryland
-
Baltimore, Maryland, Forente stater, 21205
- Johns Hopkins University School of Nursing
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
65 år og eldre (Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 65 or older
- Cognitively intact (≥ 10 on Brief Interview of Mental Status)
- Difficulty with ≥ 2 IADLS or ≥ 1 ADL
- ≤ 199% of Federal Poverty level
Exclusion Criteria:
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Helsetjenesteforskning
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Annen: Functional Services
The program consists of up to 10 home-based functional services sessions over 4 months.
|
The program consists of up to 10 home-based functional services sessions over 4 months.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Cost Effective
Tidsramme: one year after intervention
|
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
|
one year after intervention
|
|
Cost Effective
Tidsramme: two years after intervention
|
Chart review to see change between cost of intervention to medicaid before and after CAPABALE
|
two years after intervention
|
|
Cost Effective
Tidsramme: one year after intervention
|
Chart review to see change between cost of intervention to medicare before and after CAPABALE
|
one year after intervention
|
|
Cost Effective
Tidsramme: two years after intervention
|
Chart review to see change between cost of intervention to medicare before and after CAPABALE
|
two years after intervention
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire
Tidsramme: four months post intervention
|
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.
|
four months post intervention
|
|
Quality of Life as assessed by the ADL Questionnaire
Tidsramme: eight months post intervention
|
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.
|
eight months post intervention
|
|
Quality of Life as assessed by the ADL Questionnaire
Tidsramme: twelve months post intervention
|
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.
|
twelve months post intervention
|
|
Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire
Tidsramme: four months post intervention
|
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.
|
four months post intervention
|
|
Quality of Life as assessed by the IADL Questionnaire
Tidsramme: eight months post intervention
|
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.
|
eight months post intervention
|
|
Quality of Life as assessed by the IADL Questionnaire
Tidsramme: twelve months post intervention
|
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.
|
twelve months post intervention
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Sarah Szanton, Johns Hopkins University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Waldersen 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2012
Primær fullføring (Faktiske)
31. august 2018
Studiet fullført (Faktiske)
31. august 2019
Datoer for studieregistrering
Først innsendt
15. oktober 2012
Først innsendt som oppfylte QC-kriteriene
4. desember 2012
Først lagt ut (Anslag)
6. desember 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
12. februar 2020
Siste oppdatering sendt inn som oppfylte QC-kriteriene
10. februar 2020
Sist bekreftet
1. februar 2020
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- NA_00076471
- 1C1CMS330970-01-00 (Annen identifikator: Centers for Medicare and Medicaid Services)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
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