SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Not Applicable

Completed

• Conditions: Social Behavior; ESRD; Physical Disability
• Interventions: Behavioral: SOCIABLE

• Registration Number: NCT03055273
• Lead Sponsor: Johns Hopkins University

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.

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-08-31
• Study First Submitted QC: 2017-02-13
• Study First Posted: 2017-02-16
• Primary Completion: 2017-06
• Study Completion: 2017-06
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-16
• Last Update Posted: 2017-08-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SOCIABLE wait list	SOCIABLE	Receive services four months post-enrollment
SOCIABLE IMMEDIATE	SOCIABLE	Receive services now

Primary Outcome Measures

Name	Time	Method
Katz ADL	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.

Secondary Outcome Measures

Name	Time	Method
Lawton Instrumental Activities of Daily Living (IADL) measure	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

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States