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.
A tanulmány áttekintése
Állapot
Körülmények
Beavatkozás / kezelés
Részletes leírás
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.
Tanulmány típusa
Beiratkozás (Tényleges)
Fázis
- Nem alkalmazható
Kapcsolatok és helyek
Tanulmányi helyek
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Maryland
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Baltimore, Maryland, Egyesült Államok, 21205
- Johns Hopkins University
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Részvételi kritériumok
Jogosultsági kritériumok
Tanulmányozható életkorok
Egészséges önkénteseket fogad
Tanulmányozható nemek
Leírás
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
Tanulási terv
Hogyan készül a tanulmány?
Tervezési részletek
- Elsődleges cél: Egyéb
- Kiosztás: Véletlenszerűsített
- Beavatkozó modell: Párhuzamos hozzárendelés
- Maszkolás: Kettős
Fegyverek és beavatkozások
Résztvevő csoport / kar |
Beavatkozás / kezelés |
|---|---|
|
Kísérleti: SOCIABLE IMMEDIATE
Receive services now
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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.
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|
Aktív összehasonlító: 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.
|
Mit mér a tanulmány?
Elsődleges eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Katz ADL
Időkeret: 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.
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baseline
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Katz ADL
Időkeret: 4 months post intervention
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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
|
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Katz ADL
Időkeret: 8 months post intervention
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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
|
Másodlagos eredményintézkedések
Eredménymérő |
Intézkedés leírása |
Időkeret |
|---|---|---|
|
Lawton Instrumental Activities of Daily Living (IADL) measure
Időkeret: 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
Időkeret: 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
Időkeret: 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
|
Együttműködők és nyomozók
Szponzor
Nyomozók
- Tanulmányi szék: Deidra Crews, Johns Hopkins University
Tanulmányi rekorddátumok
Tanulmány főbb dátumok
Tanulmány kezdete
Elsődleges befejezés (Tényleges)
A tanulmány befejezése (Tényleges)
Tanulmányi regisztráció dátumai
Először benyújtva
Először nyújtották be, amely megfelel a minőségbiztosítási kritériumoknak
Első közzététel (Tényleges)
Tanulmányi rekordok frissítései
Utolsó frissítés közzétéve (Tényleges)
Az utolsó frissítés elküldve, amely megfelel a minőségbiztosítási kritériumoknak
Utolsó ellenőrzés
Több információ
A tanulmányhoz kapcsolódó kifejezések
További vonatkozó MeSH feltételek
Egyéb vizsgálati azonosító számok
- NA00097283
- P30AG048773 (Az Egyesült Államok NIH támogatása/szerződése)
Terv az egyéni résztvevői adatokhoz (IPD)
Tervezi megosztani az egyéni résztvevői adatokat (IPD)?
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