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

Primary Purpose

ESRD, Social Behavior, Physical Disability

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
SOCIABLE
Sponsored by
Johns Hopkins University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for ESRD

Eligibility Criteria

60 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Johns Hopkins University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

SOCIABLE IMMEDIATE

SOCIABLE wait list

Arm Description

Receive services now

Receive services four months post-enrollment

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

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
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
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

Full Information

First Posted
August 31, 2016
Last Updated
August 16, 2017
Sponsor
Johns Hopkins University
Collaborators
Roybal Center, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT03055273
Brief Title
SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Acronym
SOCIABLE
Official Title
SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
June 2017 (Actual)
Study Completion Date
June 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Johns Hopkins University
Collaborators
Roybal Center, National Institute on Aging (NIA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ESRD, Social Behavior, Physical Disability

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
12 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOCIABLE IMMEDIATE
Arm Type
Experimental
Arm Description
Receive services now
Arm Title
SOCIABLE wait list
Arm Type
Active Comparator
Arm Description
Receive services four months post-enrollment
Intervention Type
Behavioral
Intervention Name(s)
SOCIABLE
Intervention Description
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 Measure Information:
Title
Katz ADL
Description
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.
Time Frame
baseline
Title
Katz ADL
Description
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.
Time Frame
4 months post intervention
Title
Katz ADL
Description
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.
Time Frame
8 months post intervention
Secondary Outcome Measure Information:
Title
Lawton Instrumental Activities of Daily Living (IADL) measure
Description
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
Time Frame
Baseline
Title
Lawton Instrumental Activities of Daily Living (IADL) measure
Description
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
Time Frame
4 months
Title
Lawton Instrumental Activities of Daily Living (IADL) measure
Description
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
Time Frame
8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deidra Crews
Organizational Affiliation
Johns Hopkins University
Official's Role
Study Chair
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

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