SOCIABLE Seniors Optimizing Community Integration to Advance Better Living With ESRD (SOCIABLE)
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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Maryland
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Baltimore, Maryland, 미국, 21205
- Johns Hopkins University
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: SOCIABLE IMMEDIATE
Receive services now
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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.
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활성 비교기: SOCIABLE wait list
Receive services four months post-enrollment
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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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Katz ADL
기간: baseline
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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.
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baseline
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Katz ADL
기간: 4 months post intervention
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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.
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4 months post intervention
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Katz ADL
기간: 8 months post intervention
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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.
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8 months post intervention
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Lawton Instrumental Activities of Daily Living (IADL) measure
기간: Baseline
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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
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Baseline
|
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Lawton Instrumental Activities of Daily Living (IADL) measure
기간: 4 months
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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
|
4 months
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Lawton Instrumental Activities of Daily Living (IADL) measure
기간: 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
|
8 months
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공동 작업자 및 조사자
수사관
- 연구 의자: Deidra Crews, Johns Hopkins University
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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