SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD (SOCIABLE)
This research is being done to find out the best ways to help people with end stage kidney disease take care of their daily lives and improve their social functioning.
Investigators want to learn whether services in the Community Aging in Place, Advancing Better Living for Elders (CAPABLE) study such as help with medications, muscle strengthening, balance training, pain management, changes to houses and improved social support can be tailored to fit the needs of older adults with kidney disease to help improve their ability to balance, walk, and take care of themselves.
People aged 60 years and older who have end stage kidney disease and have been receiving dialyses for at least 6 months, may join.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
Questionnaires:
Participants will be asked to answer questions about:
- social support and social functioning
- pain and depression
- physical function
Study intervention:
Participants will be randomly assigned (by chance, like the flip of a coin) to one of two groups: participant either will receive SOCIABLE (Seniors Optimizing Community Integration to Advance Better Living with ESRD) services now, or will receive the same services in six months from now. Participants have a 50:50 chance of getting into each group
SOCIABLE services involve receiving visits with a nurse interviewer. Participants will decide how you want to improve your social function and social support.
Participants will also receive:
- a group of services called CAPABLE which include home visits from a nurse (RN) and an occupational therapist (OT) and a handyman for repairs if you need them and
- help with improving social support
All participants will receive 10 home visits (6 OT, 4 RN) plus minor home repairs and assistive devices over a 4 month period of time.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Maryland
-
Baltimore, Maryland, Stati Uniti, 21205
- Johns Hopkins University
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- 60 years and older
- End Stage Renal Disease on In-Center Hemodialysis for at least 6 months
- Functional limitations (difficulty in at least one of the following: bathing, dressing, walking across a room, grooming, getting on or off the toilet, getting on or off the bed);
- Low socioeconomic status (less than high School education, or household income <$25,000/year)
- Signed informed consent
Exclusion Criteria:
- Inability to understand the informed consent process and give consent via signed written consent form
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Altro
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Doppio
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: SOCIABLE IMMEDIATE
Receive services now
|
SOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease.
There is particular emphasis on supporting the social function and the physical and everyday living function.
|
|
Comparatore attivo: SOCIABLE wait list
Receive services four months post-enrollment
|
SOCIABLE services involve a nurse, and occupational therapist and a handyman to support function among older adults with end stage renal disease.
There is particular emphasis on supporting the social function and the physical and everyday living function.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Katz ADL
Lasso di tempo: baseline
|
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
|
baseline
|
|
Katz ADL
Lasso di tempo: 4 months post intervention
|
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
|
4 months post intervention
|
|
Katz ADL
Lasso di tempo: 8 months post intervention
|
Questionnaire about Activities of Daily Living such as bathing, dressing, walking, grooming and how difficult each one is to do. 8 questions and they range from 0, meaning they have no difficulty to 2 which means they can not do it even with help.
|
8 months post intervention
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Lawton Instrumental Activities of Daily Living (IADL) measure
Lasso di tempo: Baseline
|
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances.
The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
|
Baseline
|
|
Lawton Instrumental Activities of Daily Living (IADL) measure
Lasso di tempo: 4 months
|
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances.
The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
|
4 months
|
|
Lawton Instrumental Activities of Daily Living (IADL) measure
Lasso di tempo: 8 months
|
This questionnaire measures participants' abilities to do Instrumental Activities of Daily Living such as shopping, light housekeeping, and managing finances.
The scale ranges from 0 meaning they have no difficulty to 2 which means they can't do it even if they have help
|
8 months
|
Collaboratori e investigatori
Sponsor
Investigatori
- Cattedra di studio: Deidra Crews, Johns Hopkins University
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NA00097283
- P30AG048773 (Sovvenzione/contratto NIH degli Stati Uniti)
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su ESRD
-
Peking Union Medical College HospitalBeijing Anzhen Hospital; First Hospital of China Medical University; The Luhe Teaching... e altri collaboratoriTerminato
-
Satellite HealthcareCompletato
-
University of Alabama at BirminghamBaxter Healthcare CorporationCompletato
-
University of California, San FranciscoRitirato
-
Everett MeyerNational Heart, Lung, and Blood Institute (NHLBI)Attivo, non reclutante
-
Azienda Ospedaliera, Ospedale Civile di LegnanoAO Garbagnate-BollateSconosciuto
-
Northwell HealthCompletato