SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Physical Disability Clinical Trial

— SOCIABLE  

Official title:

SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03055273
• Other study ID #: NA00097283
• Secondary ID: P30AG048773
• Status: Completed
• Phase: N/A
• First received: August 31, 2016
• Last updated: August 16, 2017
• Start date: June 2016
• Est. completion date: June 2017

Study information

• Verified date: August 2017
• Source: Johns Hopkins University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: June 2017
• Est. primary completion date: June 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• ESRD
• Physical Disability
• Social Behavior

Intervention

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.

Locations

Country	Name	City	State
United States	Johns Hopkins University	Baltimore	Maryland

Sponsors (3)

Lead Sponsor	Collaborator
Johns Hopkins University	National Institute on Aging (NIA), Roybal Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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