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

4 marzo 2019 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

33

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

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

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore attivo: 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.
Sperimentale: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Pubblicazioni e link utili

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Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 ottobre 2016

Completamento primario (Effettivo)

1 settembre 2017

Completamento dello studio (Effettivo)

1 dicembre 2017

Date di iscrizione allo studio

Primo inviato

26 ottobre 2016

Primo inviato che soddisfa i criteri di controllo qualità

28 ottobre 2016

Primo Inserito (Stima)

1 novembre 2016

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

6 marzo 2019

Ultimo aggiornamento inviato che soddisfa i criteri QC

4 marzo 2019

Ultimo verificato

1 marzo 2019

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 074/2016

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

No

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

Prove cliniche su Standard Care

3
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