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临床试验/NCT03055273
NCT03055273已完成不适用

SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2016年6月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
12
试验地点
2
主要终点
Katz ADL

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
60 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

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

研究组 & 干预措施

SOCIABLE IMMEDIATE

Experimental

Receive services now

干预措施: SOCIABLE (Behavioral)

SOCIABLE wait list

Active Comparator

Receive services four months post-enrollment

干预措施: SOCIABLE (Behavioral)

结局指标

主要结局

Katz ADL

时间窗: 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.

次要结局

  • Lawton Instrumental Activities of Daily Living (IADL) measure(8 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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