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Completed

NCT Number: NCT03055273

SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOCIABLE

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Johns Hopkins University

Other

Collaborators

  • National Institute on Aging (NIA)
  • Roybal Center

Registry information

Acronym: SOCIABLE

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 16, 2017
Registry last updated
Aug 21, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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