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SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD (SOCIABLE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03055273
Recruitment Status : Completed
First Posted : February 16, 2017
Last Update Posted : August 21, 2017
Sponsor:
Collaborators:
Roybal Center
National Institute on Aging (NIA)
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
ESRD Social Behavior Physical Disability Behavioral: SOCIABLE Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Other
Official Title: SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Study Start Date : June 2016
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017

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.




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Secondary Outcome Measures :
  1. Lawton Instrumental Activities of Daily Living (IADL) measure [ Time Frame: Baseline ]
    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

  2. Lawton Instrumental Activities of Daily Living (IADL) measure [ Time Frame: 4 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

  3. Lawton Instrumental Activities of Daily Living (IADL) measure [ Time Frame: 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   60 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03055273


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Roybal Center
National Institute on Aging (NIA)
Investigators
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Study Chair: Deidra Crews Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03055273    
Other Study ID Numbers: NA00097283
P30AG048773 ( U.S. NIH Grant/Contract )
First Posted: February 16, 2017    Key Record Dates
Last Update Posted: August 21, 2017
Last Verified: August 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Kidney Failure, Chronic
Renal Insufficiency, Chronic
Renal Insufficiency
Kidney Diseases
Urologic Diseases