- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT02965469
Psychosocial Stress and Aging in HIV
14. April 2022 aktualisiert von: 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.
Studienübersicht
Status
Abgeschlossen
Bedingungen
Intervention / Behandlung
Detaillierte Beschreibung
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.
Studientyp
Interventionell
Einschreibung (Tatsächlich)
42
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienorte
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North Carolina
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Winston-Salem, North Carolina, Vereinigte Staaten, 27157
- Wake Forest University Health Sciences
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
21 Jahre und älter (Erwachsene, Älterer Erwachsener)
Akzeptiert gesunde Freiwillige
Nein
Studienberechtigte Geschlechter
Alle
Beschreibung
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
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Sonstiges
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Kein Eingriff: Usual care
Participants randomized to this arm will have no change to their usual care
|
|
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Experimental: 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
Andere Namen:
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Correlation of perceived stress with HIV virologic suppression
Zeitfenster: 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
Zeitfenster: 12 weeks
|
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
|
12 weeks
|
|
Correlation of perceived stress with inflammation
Zeitfenster: 12 weeks
|
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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Feasibility of a stress-reduction cell phone app
Zeitfenster: 12 weeks
|
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.
|
12 weeks
|
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The effect of a cell phone app on stress-reduction
Zeitfenster: 12 weeks
|
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
Zeitfenster: 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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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Mitarbeiter
Ermittler
- Hauptermittler: Katherine R Schafer, MD, Associate professor
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn
1. Mai 2016
Primärer Abschluss (Tatsächlich)
14. November 2017
Studienabschluss (Tatsächlich)
14. November 2017
Studienanmeldedaten
Zuerst eingereicht
4. November 2016
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
11. November 2016
Zuerst gepostet (Schätzen)
16. November 2016
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
15. April 2022
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. April 2022
Zuletzt verifiziert
1. Juli 2018
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- IRB00033537
- 1R03AG048033-01A1 (US NIH Stipendium/Vertrag)
Plan für individuelle Teilnehmerdaten (IPD)
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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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