SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Johns Hopkins University

Status: Completed

Conditions: ESRD; Physical Disability; Social Behavior

Treatments: Behavioral: SOCIABLE

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03055273

P30AG048773 (U.S. NIH Grant/Contract)

NA00097283

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 60 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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12 participants in 2 patient groups

SOCIABLE IMMEDIATE

Experimental group

Description:

Receive services now

Treatment:

Behavioral: SOCIABLE

SOCIABLE wait list

Active Comparator group

Description:

Receive services four months post-enrollment

Treatment:

Behavioral: SOCIABLE