- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07935434
Effectiveness and Implementation of Geriatrics Resources for Assessment and Care of Elders With HIV (GRACE-HIV) (GRACE-HIV)
The GRACE-HIV intervention is a 24-month intervention of RN care coordination guided by a multidisciplinary geriatric and HIV or "GRACE HIV" support team conducted in collaboration with a participant's health care team including any community service providers.
연구 개요
상세 설명
The GRACE-HIV intervention is a 24-month intervention of RN care coordination guided by a multidisciplinary geriatric and HIV or "GRACE HIV" support team conducted in collaboration with a participant's health care team including any community service providers. The intervention is designed to integrate geriatric and HIV services to ensure older adults with HIV experiencing poverty receive appropriate and evidence based care for comorbid and geriatric conditions.
연구 유형
등록 (추정된)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Eligible participants will be a) age 50 or older, b) receive HIV care (at least 1 visit at the same site within the past 12 months) from either Eskenazi Health IDC or LifeCare clinics, c) able to provide informed consent or have a legally authorized representative provide informed consent based on teach back processes described in recruitment procedures below , d) have a household income below 300% of the federal poverty level, and e) be English or Spanish speaking. The income criteria correspond to the eligibility criteria to receive Ryan White Services in Indiana.
Exclusion Criteria:
- We will exclude patients who are long-term nursing home residents as the nursing home team is their primary medical team and Ryan White funding does not support long term care services.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: GRACE-HIV
|
Each participant randomized to the intervention will undergo an initial visit at their home or preferred location, where the RN will conduct a comprehensive geriatric assessment including physical, cognitive, functional, psychosocial and community needs assessment, and a medication review including prescribed and over the counter medications. After the initial visit, the RN attends the weekly multidisciplinary team meeting to discuss the findings which trigger evidence-based geriatric HIV care protocols for inclusion in the personalized care plan. After multidisciplinary review, the RN will coordinate with the participant's HIV care team, and when relevant, with primary care, specialists, pharmacists, social workers, and community service organizations to refine and implement the care plan. |
|
간섭 없음: Measure of Usual Care
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Health Related Quality of Life
기간: Baseline, 6month, 12 month, 18month and 24 month.
|
Medical Outcomes Short Form Survey36 (SF-36) to measure health related quality of life. The SF-36 includes eight scales measuring domains of physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health. Our primary outcome measure is the Component Summary Scores |
Baseline, 6month, 12 month, 18month and 24 month.
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Geriatric Syndrome Identification and Management
기간: Baseline, 6month, 12 month, 18month and 24 month.
|
This outcome is a 24-month participant level Geriatric Syndrome Identification and Management Process Score, derived from EHR, medication, and referral data in both study arms. The composite will be defined as the number of eligible care processes completed divided by the number of eligible care processes during 24 months of follow-up. Components will include: (1) identification of key geriatric syndromes in the EHR, including falls/fall risk, depression, cognitive impairment or dementia, urinary incontinence, and polypharmacy and (2) management of identified syndromes, including medication reconciliation, syndrome-specific treatment or referral, prescribing of indicated medications such as antidepressants or dementia medications when clinically appropriate, and deprescribing of potentially inappropriate medications. Higher scores will indicate better delivery of recommended geriatric care processes. |
Baseline, 6month, 12 month, 18month and 24 month.
|
|
Acute care healthcare utilization
기간: Baseline, 6month, 12 month, 18month and 24 month.
|
We will collect emergency department visits and hospitalization data from the Indiana Network for Patient Care, the health information exchange for the State of Indiana. |
Baseline, 6month, 12 month, 18month and 24 month.
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
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 연구와 관련된 용어
기타 연구 ID 번호
- 32913
- 1R01AG102221-01 (미국 NIH 보조금/계약)
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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