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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Maryland
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Baltimore, Maryland, États-Unis, 21205
- Johns Hopkins University
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: 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.
|
|
Comparateur actif: 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.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Katz ADL
Délai: 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
Délai: 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
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Lawton Instrumental Activities of Daily Living (IADL) measure
Délai: 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
Délai: 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
Délai: 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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chaise d'étude: Deidra Crews, Johns Hopkins University
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- NA00097283
- P30AG048773 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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