SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Johns Hopkins University
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Katz ADL
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 60 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
SOCIABLE IMMEDIATE
Receive services now
Intervention: SOCIABLE (Behavioral)
SOCIABLE wait list
Receive services four months post-enrollment
Intervention: SOCIABLE (Behavioral)
Outcomes
Primary Outcomes
Katz ADL
Time Frame: 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.
Katz ADL
Time Frame: baseline
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.
Katz ADL
Time Frame: 4 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 Outcomes
- Lawton Instrumental Activities of Daily Living (IADL) measure(8 months)
- Lawton Instrumental Activities of Daily Living (IADL) measure(Baseline)
- Lawton Instrumental Activities of Daily Living (IADL) measure(4 months)