Eine kurze kognitive Aufgabenintervention für NHS-Mitarbeiter, die von einem COVID-19-Trauma betroffen sind (GAINS-2-Studie) (GAINS-2)
Eine randomisierte kontrollierte Studie einer kurzen kognitiven Aufgabenintervention zur Unterstützung von NHS-Mitarbeitern, die aufdringliche Erinnerungen an traumatische Ereignisse aus der Arbeit in der COVID-19-Pandemie erleben.
Mitarbeiter des Gesundheitswesens an vorderster Front sind bei der Arbeit häufig traumatischen Ereignissen ausgesetzt (z. B. wenn sie Zeuge des Todes von Patienten werden), verstärkt durch die COVID-19-Pandemie. Ein erheblicher Anteil erlebt aufdringliche Erinnerungen an diese Ereignisse, die plötzlich in den Sinn kommen: Sie können das Funktionieren stören und zu einer posttraumatischen Belastungsstörung beitragen. Frühere Forschungen haben gezeigt, dass eine kurze Verhaltensintervention die Anzahl aufdringlicher Erinnerungen nach einem traumatischen Ereignis reduzieren kann. In dieser Studie werden wir die Wirkung einer digitalen Bilderwettbewerbsaufgabe, einer digitalen Musikhöraufgabe und einer Behandlung wie gewohnt (TAU) für Mitarbeiter des Nationalen Gesundheitsdienstes (NHS) mit aufdringlichen Erinnerungen an arbeitsbedingte traumatische Ereignisse aus der Pandemie testen. Wir testen die Wirkung auf die Anzahl der aufdringlichen Erinnerungen (primäres Ergebnis) und andere klinische Symptome (PTBS, Angst, Depression und Schlaflosigkeit) zusätzlich zu der Arbeitsfunktion, der allgemeinen Funktionsfähigkeit und der Lebensqualität (sekundäre Ergebnisse). Durchführbarkeit, Akzeptanz und Umsetzung von Interventionen werden ebenfalls untersucht (zusätzliche Ergebnisse). Wir werden ungefähr 150 NHS-Mitarbeiter (über die Intensive Care Society, soziale Medien und Direktwerbung von NHS Trusts) mit aufdringlichen Erinnerungen an traumatische Ereignisse, die während der COVID-19-Pandemie erlebt wurden, rekrutieren.
Die Studie wird vom Wellcome Trust (223016/Z/21/Z) finanziert.
Studienübersicht
Status
Detaillierte Beschreibung
Vor der ersten Zwischenanalyse wird ein statistischer Analyseplan unter Verwendung von Bayes-Analysen für statistische Schlussfolgerungen erstellt.
Regelmäßige Überwachung wird von P1vital Products durchgeführt, um sicherzustellen, dass die Studie durchgeführt wird und Daten in Übereinstimmung mit dem Protokoll, GCP und den geltenden behördlichen Anforderungen generiert, dokumentiert und gemeldet werden. Qualitätssicherungsvertreter des Sponsors können ein Audit der Studie in Übereinstimmung mit behördlichen Richtlinien und relevanten Standardarbeitsanweisungen durchführen.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Oxfordshire
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Wallingford, Oxfordshire, Vereinigtes Königreich, OX10 8BA
- P1vital Products Ltd
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Beschreibung
Einschlusskriterien:
- Ab 18 Jahren.
- Englisch lesen, schreiben und sprechen können.
- Arbeitete während der COVID-19-Pandemie in einer klinischen Rolle mit COVID-19-Patienten im NHS.
- Mindestens ein traumatisches Ereignis im Zusammenhang mit ihrer klinischen Arbeit während der COVID-9-Pandemie erlebt, das Kriterium A des Diagnostischen und Statistischen Handbuchs für psychische Störungen, 5 zu tatsächlichem oder drohendem Tod, schwerer Verletzung oder sexueller Gewalt“ durch „direktes Erleben des/der traumatischen Ereignisse(s)“ oder „persönliches Miterleben des/der Ereignisse, wie es anderen widerfahren ist“.
- Erleben Sie aufdringliche Erinnerungen an das/die traumatische(n) Ereignis(se).
- Hatte in der Woche vor dem Screening mindestens drei aufdringliche Erinnerungen.
- Internetzugang haben.
- Bereit und in der Lage, eine Einverständniserklärung abzugeben und Studienverfahren abzuschließen
- Bereit und in der Lage, während der Studienzeit vom Forschungsteam kontaktiert zu werden.
- Haben an keiner früheren Studie zu dieser Intervention dieses Forschungsteams teilgenommen
Ausschlusskriterien:
• Weniger als drei aufdringliche Erinnerungen während der Einlaufwoche haben.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
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Experimental: Kurze Wettbewerbsaufgabe für digitale Bilder
Zugang zu einer kurzen Wettbewerbsaufgabe für digitale Bilder für 24 Wochen (die ersten 4 Wochen mit optionaler Unterstützung durch Forscher).
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Erste Sitzung unter Anleitung eines Forschers: Ein Erinnerungshinweis, gefolgt vom Spielen eines Computerspiels mit Anweisungen zur mentalen Rotation. Option zur Teilnahme an selbstverwalteten/geführten Sitzungen nach der ersten Sitzung. |
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Experimental: Kurze Aufgabe zum digitalen Musikhören
Zugang zu einer kurzen digitalen Musikhöraufgabe für 24 Wochen (erste 4 Wochen mit optionaler Unterstützung durch Forscher).
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Von einem Forscher geleitete erste Sitzung: Informationen über die Musik des Komponisten, gefolgt vom Hören klassischer Musik. Option zur Teilnahme an selbstverwalteten/geführten Sitzungen nach der ersten Sitzung. |
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Experimental: Behandlung wie gewohnt
Zugang zu routinemäßiger Versorgung, die die Teilnehmer ansonsten erhalten würden, wenn sie 24 Wochen lang aufdringliche Erinnerungen an traumatische Ereignisse haben.
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Zugang zu routinemäßiger Versorgung, die die Teilnehmer sonst erhalten würden, wenn sie aufdringliche Erinnerungen an traumatische Ereignisse haben.
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Number of Intrusive Memories of Traumatic Event(s)
Zeitfenster: Run-in/screening week, Week 4 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/screening week, Week 4 (all arms)
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
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Schlafzustandsanzeige (SCI)
Zeitfenster: Ausgangswert, 4 Wochen, 12 Wochen und 24 Wochen (alle Arme)
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Diese 2-Punkte-Skala misst Schlafprobleme anhand der DSM-5-Kriterien für Schlaflosigkeitsstörungen.
Die Item-Antworten werden jeweils mit 0–4 bewertet, wobei die Werte 0–2 Schwellenkriterien für eine Schlaflosigkeitsstörung angeben.
Die Gesamtpunktzahl liegt zwischen 0 und 8, wobei eine höhere Punktzahl auf einen besseren Schlaf hinweist.
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Ausgangswert, 4 Wochen, 12 Wochen und 24 Wochen (alle Arme)
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Number of Intrusive Memories of Traumatic Event(s)
Zeitfenster: Run-in/Screening week, Weeks 12 and 24 (all arms)
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Number of intrusive memories of traumatic event(s) recorded by participants in a brief daily online diary for 7 days.
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Run-in/Screening week, Weeks 12 and 24 (all arms)
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PTSD Checklist for DSM-5 (PCL-5)
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 20-item measure assesses symptoms of PTSD over the last week.
Items are rated on a 5-point scale ranging from 0 ("not at all") to 4 ("extremely").
Scores are summed to give a total severity score (ranging 0 to 80), with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Generalised Anxiety Disorder 2-item Scale (GAD-2)
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 2-item short-form self-report measure assesses symptoms of anxiety.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Patient Health Questionnaire 2-item Version (PHQ-2)
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 2-item short-form self-report measure assesses symptoms of depression.
Items are rated for how often they have bothered the respondent over the last two weeks, from 0 ("not at all") to 3 ("nearly every day").
Total score is the sum of both items and ranges from 0 to 6, with greater scores indicating greater symptom severity.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Engagement Total Score
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work engagement subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work engagement.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Scale of Work Engagement and Burnout (SWEBO) - Work Burnout Total Score
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This 19-item self-report measure assesses work engagement and burnout.
The work engagement subscale consists of 10 items assessing three dimensions (vigour, attentiveness, dedication).
The burnout subscale consists of 9 items assessing three dimensions (exhaustion, disengagement and inattentiveness).
Respondents rate how often they have felt each descriptive in the past two weeks, from 1 (not at all) to 4 (all the time).
The work burnout subscale total score is calculated as a mean of items (range 1-4), with greater scores indicating greater work burnout.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Sickness Absence
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Single item assessing self-reported number of sick days taken from work in the last 4 weeks.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intention to Leave Job
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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3 items assess participants' intention to leave their job e.g.
"I think a lot about leaving the job", each rated from 1 (strongly agree) to 5 (strongly disagree).
The total score ranges 3 to 15, with a lower score indicating stronger intention to leave the job.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Mobility
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The mobility item is scored on a 5-point ordinal scale from "I have no problems in walking about" to "I am unable to walk about".
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Self Care
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The self care item is scored on a 5-point ordinal scale from "I have no problems washing or dressing myself" to "I am unable to wash or dress myself".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Usual Activities
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The usual activities item is scored on a 5-point ordinal scale from "I have no problems doing my usual activities" to "I am unable to do my usual activities".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Pain / Discomfort
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The pain / discomfort item is scored on a 5-point ordinal scale from "I have no pain or discomfort" to "I have extreme pain or discomfort".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Anxiety / Depression
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief, five-item measure for assessing general quality of life and health status.
Items assess mobility, self-care, usual activities, pain/discomfort and anxiety/depression each on a 5-point scale.
The anxiety / depression item is scored on a 5-point ordinal scale from "I am not anxious or depressed" to "I am extremely anxious or depressed".
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Baseline, Week 4, Week 12 and Week 24
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5-level European Quality of Life 5 Dimension (EQ-5D-5L), Overall Health
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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The 5-level version of the EuroQol-5D (EQ-5D-5L) is a brief measure for assessing general quality of life and health status.
Respondents rate their overall health today on a visual analogue scale from 0 (the worst health you can imagine) to 100 (the best health you can imagine).
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Baseline, Week 4, Week 12 and Week 24
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World Health Organization Disability Assessment Schedule 12-item Version (WHODAS 2.0)
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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The 12-item, self-report version of the WHODAS 2.0 will be used to assess difficulties in relation to the impact of intrusive memories.
Respondents rate how much difficulty they have had in each area in the past 30 days, from 0 (none) to 4 (extreme or cannot do).
The overall score is calculated as a percentage of the maximum possible score (i.e., 48 points), with greater scores indicating greater impairment.
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Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 1. Approximately How Often Did Intrusive Memories of the Traumatic Event Pop Into Your Mind?
Zeitfenster: Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 1 assessing the frequency of intrusive memories on a 7-point scale from 'never' to 'many times a day'. Other items from this questionnaire are presented below. |
Baseline, 4 weeks, 12 weeks and 24 weeks (all arms)
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Intrusive Memory Ratings: Item 4a. Duration of Interference
Zeitfenster: Baseline, Week 4, Week 12 and Week 24 (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present Item 4a assessing the for how long intrusive memories interfered with what participants were doing on a 7-point scale from '<1 min' to '>60 mins'. Other items from this questionnaire are presented below. |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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Intrusive Memory Ratings: Distress (Item 2), Disruption to Concentration (Item 3), Interference (Item 4), Impact on Work Functioning (Item 5), and Impact on Functioning in Other Areas of Life (Item 7)
Zeitfenster: Baseline, Week 4, Week 12 and Week 24 (all arms)
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This questionnaire assesses a number of intrusive memories characteristics, including frequency (Item 1: 7-point categorical response from 'never' to 'many times a day'); distress (Item 2: 0=not at all to 10=extremely); disruption to concentration (Item 3: 0=not at all to 10=extremely); interference (Item 4: how much (0=not at all to 10=extremely), and Item 4a: for how long (6-point response from '<1min' to '>60mins')); impact on work functioning (Item 5: how much (0=not at all to 10=extremely) and Item 6: in what ways (open text response)); impact on functioning in other areas of life (Item 7: how much (0=not at all to 10=extremely) and in what ways (Item 8: open text response)). Here we present data for the five items scored on an 11-point scale (0=not at all to 10=extremely) assessing distress (Item 2), disruption to concentration (Item 3), interference (Item 4), impact on work functioning (Item 5), and impact on functioning in other areas of life (Item 7). |
Baseline, Week 4, Week 12 and Week 24 (all arms)
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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Changes to Health and Work - Dichotomous Outcomes
Zeitfenster: 4 weeks, 12 weeks and 24 weeks (all arms)
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The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Dichotomous outcomes are presented below, and discrete outcomes with count data are presented under "Changes to health and work - discrete outcomes".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Changes to Health and Work - Discrete Outcomes
Zeitfenster: 4 weeks, 12 weeks and 24 weeks (all arms)
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The 9-item questionnaire will be used to assess the occurrence and number of any new traumatic events, any additional stressful life events (e.g.
relationship problems, financial problems), new treatments received, untoward medical occurrences, changes to the job, or changes to the number of hours worked per week since the last assessment.
Discrete outcomes are presented below, and dichotomous outcomes are presented under "Changes to health and work - dichotomous outcomes".
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4 weeks, 12 weeks and 24 weeks (all arms)
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Feedback Questionnaire
Zeitfenster: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cogntive task, both with an open response.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Feedback Questionnaire (Total Score)
Zeitfenster: After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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A 12-item questionnaire assessing participants' experience of using the brief cognitive task.
The first ten items assess how easy, helpful, distressing, burdensome and acceptable participants found the brief cognitive task, how willing they would be to use it in the future, how confident they would be in recommending it to a friend and how much they feel it could be used to support staff within the NHS, each rated from 0 (not at all) to 10 (very); items for distress and burden are reverse scored from 0 (very) to 10 (not at all).
The last two items ask how the brief cognitive task could be improved, and for any other comments or suggestions about the brief cognitive task, both with an open response.
A total score of the eight categorical items is presented (range 0 - 80), with greater scores indicating more favourable feedback towards the allocated digital task.
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After 4 weeks (brief imagery-competing task and brief music listening task arms only)
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Optional Qualitative Interview
Zeitfenster: Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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This semi-structured interview will consist of a number of questions designed to gain an in-depth understanding of participants' experience of using the brief cognitive task, including acceptability, improvement suggestions, and potential barriers/facilitators to implementation.
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Week 4 and Week 24 (brief imagery competing task and brief music listening task arms only)
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Weekly Work Pattern, Number of Days Worked
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of days worked in the last week (both with responses from 0 to 7 days).
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Baseline, Week 4, Week 12 and Week 24
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Weekly Work Pattern, Number of Night Shifts Worked
Zeitfenster: Baseline, Week 4, Week 12 and Week 24
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One item asses the number of night shifts worked in the last week (both with responses from 0 to 7).
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Baseline, Week 4, Week 12 and Week 24
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Categorical Items
Zeitfenster: Day 0 (post-randomisation)
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The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
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Day 0 (post-randomisation)
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Expectancy of Intervention Effect (Credibility and Expectancy Questionnaire, CEQ) - Total Score
Zeitfenster: Day 0 (post-randomisation)
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The Credibility and Expectancy Questionnaire (CEQ) consists of 6 items.
Items 1, 2, 3, and 5 were assessed on a 9-point integer scale ranging from 1 ("not at all") to 9 ("very").
Items 4 and 6 were assessed on an 11-point scale (response range of 0-100%) and, for comparability, were converted to the same 9-point scale as other items.
CEQ total score was calculated by summing all six items producing a possible total score range of 6-54; with greater scores indicating greater credibility and expectancy of intervention effect.
Participants completed the Credibility and Expectancy Questionnaire (CEQ) after being informed of treatment allocation (Day 0).
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Day 0 (post-randomisation)
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Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Studienleiter: Emily Holmes, Uppsala University (UU), Sweden
- Hauptermittler: Amy Beckenstrom, P1vital Products, Wallingford
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- P1V-GAINS-IN02
Plan für individuelle Teilnehmerdaten (IPD)
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OSF ist eine Open-Source-Webanwendung, die der Öffentlichkeit und der wissenschaftlichen Gemeinschaft frei zugänglich ist.
Art der unterstützenden IPD-Freigabeinformationen
- STUDIENPROTOKOLL
- SAFT
- ANALYTIC_CODE
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