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RCT Examining the Effectiveness of Digital Picture Frame Use in Inpatient Setting

4. März 2019 aktualisiert von: Sean Kidd, Centre for Addiction and Mental Health

A Randomized Controlled Trial Examining the Effectiveness of Digital Picture Frame Use on the Long Term Inpatient Experience

This study will be a randomized controlled trial that investigates the effectiveness of digital picture frames (DPF) installed in inpatient rooms on long stay inpatient wards servicing schizophrenia clients at CAMH. The effects on client experience will consider the domains of self-concept, interactions with healthcare staff, perception of space, and implications for the recovery process. The comparison of inpatient client experience with DPFs versus a control group (Treatment as Usual - TAU), offers the opportunity to examine the effectiveness of this type of environmental adaptation. This trial builds upon earlier work that demonstrated the feasibility of DPFs in this context.

Studienübersicht

Detaillierte Beschreibung

Long term stays in mental health facilities have been shown to have unique challenges and implications. To a considerable extent these challenges grow out of the stigmatized nature of severe mental illnesses (SMI) such as schizophrenia. The social and self-stigma surrounding SMI can have major effects on those affected including decreased self-esteem, self-deprecation, and the development of a self-concept defined by the illness. When stigmatized interpretations of mental illness are internalized, those affected can find it very challenging to sustain non-illness identities and can ultimately result in the loss of non-illness related aspects of self-concept. Inpatient contexts are particularly challenging in this regard, with non-illness oriented identities very difficult to sustain given considerations of power differentials with providers, the reduction of autonomy and choice, and the removal of the individual from environments that are demonstrative of non-illness aspects of self.

Accordingly, a randomized controlled trial design will be used to consider the question: Does having a DPF in psychiatric inpatient unit rooms lead to improvements in interactions with the clinical team, perceptions of enhanced quality of physical space, and an improvement in the sustaining of non-illness aspects of self-concept? While the promising feasibility study findings might suggest hypotheses of improvement in these domains, we will consider this study exploratory given the complex environments inpatient units represent in the study of care quality and outcomes and the modest scope of this intervention. Finally, we will continue to collect feasibility data qualitatively, to inform further refinement of metrics and otherwise consider enhancements in intervention and research design.

Studientyp

Interventionell

Einschreibung (Tatsächlich)

33

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

    • Ontario
      • Toronto, Ontario, Kanada, M5T 1R8
        • Centre for Addiction and Mental Health

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

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

Inclusion Criteria:

  • All participants will have severe mental illness (SMI) defined as diagnosis with a major mental illness (in practice, will be primarily schizophrenia spectrum) and inherent to hospital admission will be substantive contact with services and disability affecting day-to-day functioning (Ruggeri, Leese, Thornicroft, Bisoffi, & Michelle, 2000).
  • Admitted to a CAMH inpatient unit, specifically units 2-2 and 2-3, with an anticipated length of stay of 4 weeks or more, as determined by the clinical team
  • Chart diagnosis of a major mental illness
  • Determined appropriate for study by staff psychiatrist and clinical team (capacity to consent confirmed, no precautions against having the device in the participant's room indicated)
  • 18 years of age or older
  • Proficiency in English

Exclusion Criteria:

  • Do not meet the above criteria

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Unterstützende Pflege
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Keine (Offenes Etikett)

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Standard Care
Routine care is comprised of a high level of support from an interdisciplinary team with access to unit-specific and centralized programming
High level of support from an interdisciplinary team.
Experimental: Digital Picture Frames

Setup: Over 1-2, approximately 30 minute meetings pictures will be uploaded onto the device from picture files provided by the participant and/or their family or an open online source (e.g., Google Images) that are relevant and of interest to the participant.

Installation: The picture frames are secured to a surface in the participant's room (most typically a table) by facilities staff. Participants are instructed in its use.

Check in: At midpoint (2 weeks) an RA will check in with the participant to informally discuss whether or not it continues to work, is being used, and if they want more pictures uploaded. If the latter is requested step 1 will be repeated.

The intervention is the provision of digital picture frames in long stay inpatient rooms in a ward at CAMH.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
Zeitfenster: Baseline and after 4 weeks (post intervention)
To examine the degree to which inpatient staff are perceived as recognizing the individuality of the individual and engage in a hopeful and holistic manner. 4 items from the patient version will be used (1-5 point Likert scale).
Baseline and after 4 weeks (post intervention)
Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson et al., 1995)
Zeitfenster: After 4 weeks (post intervention)
Investigators will only use the general satisfaction question from this measure (1-5 point Likert scale). Only participants in the intervention arm will complete this question.
After 4 weeks (post intervention)
Change in Empowerment Scale (Rogers et al., 1997)
Zeitfenster: Baseline and after 4 weeks (post intervention)
Measures dimensions of self efficacy, self stigma and self concept (1-9 point Likert scale).
Baseline and after 4 weeks (post intervention)
Change in Modified Engulfment Scale (McCay & Seeman, 1998)
Zeitfenster: Baseline and after 4 weeks (post intervention)
Only two items from this measure focussing specifically on self-concept will be used (1-5 point Likert scale).
Baseline and after 4 weeks (post intervention)
Change in Rosenberg Self-Esteem Scale (Rosenberg, 1965)
Zeitfenster: Baseline and after 4 weeks (post intervention)
The broadest reaching and high factor loading item, 'On the whole I am satisfied with myself' will be used (1-4 point Likert scale).
Baseline and after 4 weeks (post intervention)
Change in Scale to Assess Therapeutic Relationship (STAR; Mcguire-Snieckus et al., 2007)
Zeitfenster: Baseline and after 4 weeks (post intervention)
Three items assessing common factors in the therapeutic relationship with the clinical team are from the scale will be used (1-5 point Likert scale).
Baseline and after 4 weeks (post intervention)
Change in Satisfaction with the physical environment of the inpatient unit
Zeitfenster: Baseline and after 4 weeks (post intervention)
One question developed my investigators due to lack of standardized measures to specifically measure participant satisfaction with the physical environment of the inpatient unit (1-5 point Likert scale)
Baseline and after 4 weeks (post intervention)
Change in Satisfaction with the rooms on the inpatient unit
Zeitfenster: Baseline and after 4 weeks (post intervention)
One question developed by investigators due to lack of standardized measures to specifically measure participant satisfaction with their room on the inpatient unit (1-5 point Likert scale)
Baseline and after 4 weeks (post intervention)
Semi structured interviews
Zeitfenster: After 4 weeks (post intervention)
SC participants will be asked broad questions about how satisfied they were with the inpatient unit space and what might be improved. These same questions will be asked of DPF participants, but will be followed by questions specific to the DPF support.
After 4 weeks (post intervention)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Publikationen und hilfreiche Links

Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.

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 (Tatsächlich)

1. Oktober 2016

Primärer Abschluss (Tatsächlich)

1. September 2017

Studienabschluss (Tatsächlich)

1. Dezember 2017

Studienanmeldedaten

Zuerst eingereicht

26. Oktober 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

28. Oktober 2016

Zuerst gepostet (Schätzen)

1. November 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

6. März 2019

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. März 2019

Zuletzt verifiziert

1. März 2019

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Andere Studien-ID-Nummern

  • 074/2016

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

Nein

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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