- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02965469
Psychosocial Stress and Aging in HIV
2022년 4월 14일 업데이트: Wake Forest University Health Sciences
The Syndemic of Stress and Aging in an HIV-infected Population
This study will begin to assess the association between perceived stress and enhanced aging in persons living with HIV (PLWH).
The investigators suspect this relationship may be mediated by increased aging within the immune system and subsequent low-level inflammation that commonly leads to multiple illnesses and frailty as one ages.
The findings from this study will identify potential diagnostic and therapeutic targets to improve the health of aging PLWH which could also apply to HIV-uninfected populations.
연구 개요
상세 설명
While life expectancy has increased markedly for people living with HIV (PLWH), gains in expected years of life have come at a cost - earlier onset and greater frequency of age-associated comorbid conditions, such as osteoporosis, metabolic syndrome, and cardiovascular disease.
Accumulated multi-morbidity is the likely cause of much higher than age-expected rates of frailty in PLWH.
Perceived stress is prevalent in PLWH and, when present, associated with worse clinical outcomes, including poor engagement in HIV care, rapid progression to AIDS, and higher AIDS-related mortality.
Stress is a well-documented risk factor for many illnesses that demonstrate early onset in PLWH, and perceived stress has been hypothesized to be a cause of aging itself.
Nonetheless, the role of perceived stress in early-onset aging and age-related illness in PLWH is essentially unexplored.
Investigating the interrelatedness of aging, perceived stress, and HIV may elucidate mechanism(s) that underlie a phenotype of premature aging and functional decline in HIV patients with implications for understanding fundamental mechanisms of stress and aging in HIV uninfected populations.
The proposed randomized controlled study will estimate correlations between perceived stress and both aging and HIV-specific outcomes and will measure feasibility of a cell phone-delivered stress reduction intervention.
Participants will complete structured interviews to measure cumulative life stress, perceived stress, intimate partner violence exposure (as a traumatic stressor), functional status, frailty, and potential covariates across the age spectrum in PLWH.
Stress measures will be correlated with biomarkers known to be associated with functional decline in aging, HIV-uninfected populations.
The findings from this exploratory R03, led by a New Investigator, will measure feasibility of mobile technology for stress reduction interventions and estimate correlations between perceived stress and markers of aging and HIV disease.
The results will be used to determine sample sizes necessary to perform definitive studies to assess the link between perceived stress and a phenotype of premature aging, as well as interventional studies of stress modification to mitigate the onset of early multi-morbidity and functional decline.
These findings can be applicable to both HIV-infected and HIV-uninfected populations.
연구 유형
중재적
등록 (실제)
42
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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North Carolina
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Winston-Salem, North Carolina, 미국, 27157
- Wake Forest University Health Sciences
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
21년 이상 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- HIV positive serostatus
- Wake Forest ID clinic patient for at least 12 months
- prescribed ART for at least 6 months
- English fluency (cell phone app and some interview tools are only available in English)
- consistent access to a smartphone
Exclusion Criteria:
- ART-naive
- unable to perform functional measures
- recent (within 30 days) acute illness requiring medical therapy or hospitalization
- immunosuppressive agents (e.g. > 20 mg/d prednisone or equivalent, chemotherapy, biologic immune-modulating agents) in the last 6 months
- cancer requiring treatment within 3 years (except for non-melanoma skin cancer)
- use of non-steroidal anti-inflammatory drugs more frequently than once per week within the last 30 days.
Criteria iii-vi are necessary because of their effects on biomarkers of aging
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: Usual care
Participants randomized to this arm will have no change to their usual care
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실험적: Cell phone app
Participants randomized to this arm will use a stress reduction cell phone app called "Breathe2Relax" to assess feasibility and acceptability
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The app teaches diaphragmatic breathing and has audiovisual coaching
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Correlation of perceived stress with HIV virologic suppression
기간: 12 weeks
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Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with HIV viral load
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12 weeks
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Correlation of perceived stress with immune senescence
기간: 12 weeks
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Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of immune senescence, including IL-6, soluble CD-14, telomere length, and DNA methylation
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12 weeks
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Correlation of perceived stress with inflammation
기간: 12 weeks
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Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with biomarkers of inflammation (C-reactive protein, salivary cortisol)
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12 weeks
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Correlation of perceived stress with frailty phenotype
기간: 12 weeks
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Measure perceived stress using the Perceived Stress Scale (PSS) and calculate the correlation with each participant's Fried Frailty Index score (comprised of 5 items, including weight loss, exhaustion, 4 meter walk time, physical activity, and grip strength).
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12 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Feasibility of a stress-reduction cell phone app
기간: 12 weeks
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This outcome will measure the accrual, adherence and retention of using a stress-reduction cell phone application in people aging with HIV through the randomized pilot study.
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12 weeks
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The effect of a cell phone app on stress-reduction
기간: 12 weeks
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The study will collect preliminary data on the efficacy of a cell phone-based stress reduction intervention versus usual care for improving markers of inflammation and aging, as well as HIV-specific outcomes.
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12 weeks
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Acceptability of a stress-reduction cell phone app
기간: 12 weeks
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An exit survey will measure the acceptability of using a stress-reduction cell phone application in people aging with HIV.
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12 weeks
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Katherine R Schafer, MD, Associate professor
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2016년 5월 1일
기본 완료 (실제)
2017년 11월 14일
연구 완료 (실제)
2017년 11월 14일
연구 등록 날짜
최초 제출
2016년 11월 4일
QC 기준을 충족하는 최초 제출
2016년 11월 11일
처음 게시됨 (추정)
2016년 11월 16일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2022년 4월 15일
QC 기준을 충족하는 마지막 업데이트 제출
2022년 4월 14일
마지막으로 확인됨
2018년 7월 1일
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. .