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.

Study Overview

• Status: Completed
• Conditions: ESRD; Physical Disability; Social Behavior
• Intervention / Treatment: Behavioral: SOCIABLE

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 Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: SOCIABLE IMMEDIATE; Receive services now	Behavioral: SOCIABLE; 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.
Active Comparator: SOCIABLE wait list; Receive services four months post-enrollment	Behavioral: SOCIABLE; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Katz ADL	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	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	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Lawton Instrumental Activities of Daily Living (IADL) measure	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	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	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

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: National Institute on Aging (NIA); Roybal Center
• Investigators: Study Chair: Deidra Crews, Johns Hopkins University

Study record dates

Study Major Dates

• Study Start: June 1, 2016
• Primary Completion (Actual): June 1, 2017
• Study Completion (Actual): June 1, 2017

Study Registration Dates

• First Submitted: August 31, 2016
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 16, 2017

Study Record Updates

• Last Update Posted (Actual): August 21, 2017
• Last Update Submitted That Met QC Criteria: August 16, 2017
• Last Verified: August 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: NA00097283; P30AG048773 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED