Clinical trial NCT03055273: SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Official title: SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ESRD
Social Behavior
Physical Disability
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Roybal Center
name: National Institute on Aging (NIA)
First posted: 2017-02-16
Enrollment: 12
Sex: ALL
Minimum age (years): 60
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Katz ADL
timeFrame: baseline
measure: Katz ADL
timeFrame: 4 months post intervention
measure: Katz ADL
timeFrame: 8 months post intervention
Secondary outcomes:
measure: Lawton Instrumental Activities of Daily Living (IADL) measure
timeFrame: Baseline
measure: Lawton Instrumental Activities of Daily Living (IADL) measure
timeFrame: 4 months
measure: Lawton Instrumental Activities of Daily Living (IADL) measure
timeFrame: 8 months
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Deidra Crews
role: STUDY_CHAIR
References: