SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Study Overview
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Brief Summary
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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
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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.

Official Title
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SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Conditions
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ESRD, Social Behavior, Physical Disability

Intervention / Treatment
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* Behavioral: SOCIABLE


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 |