SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

NCT03055273 | Completed

• 2 other identifiers: NA00097283P30AG048773
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

ESRD; Social Behavior; Physical Disability

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Lawton Instrumental Activities of Daily Living (IADL) measure

  Baseline

• Lawton Instrumental Activities of Daily Living (IADL) measure

  4 months

• Lawton Instrumental Activities of Daily Living (IADL) measure

  8 months

Study Arms (2)

SOCIABLE IMMEDIATE

EXPERIMENTAL

Receive services now

Behavioral: SOCIABLE

SOCIABLE wait list

ACTIVE COMPARATOR

Receive services four months post-enrollment

Behavioral: SOCIABLE

Interventions

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.

SOCIABLE IMMEDIATE; SOCIABLE wait list

Eligibility Criteria

• Age: 60 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Inability to understand the informed consent process and give consent via signed written consent form

Sponsors & Collaborators

• Johns Hopkins University: lead
• Roybal Center: collaborator
• National Institute on Aging (NIA): collaborator

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Social Behavior

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Deidra Crews

  Johns Hopkins University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: February 16, 2017
• Study Start: June 1, 2016
• Primary Completion: June 1, 2017
• Study Completion: June 1, 2017
• Last Updated: August 21, 2017

Record last verified: 2017-08

Locations

US (1)