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

Primary Purpose

Schizophrenia, Psychosis, Psychosis NOS

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Digital Picture Frame
Standard Care
Sponsored by
Centre for Addiction and Mental Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Schizophrenia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Addiction and Mental Health

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Care

Digital Picture Frames

Arm Description

Routine care is comprised of a high level of support from an interdisciplinary team with access to unit-specific and centralized programming

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.

Outcomes

Primary Outcome Measures

Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
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).
Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson et al., 1995)
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.
Change in Empowerment Scale (Rogers et al., 1997)
Measures dimensions of self efficacy, self stigma and self concept (1-9 point Likert scale).
Change in Modified Engulfment Scale (McCay & Seeman, 1998)
Only two items from this measure focussing specifically on self-concept will be used (1-5 point Likert scale).
Change in Rosenberg Self-Esteem Scale (Rosenberg, 1965)
The broadest reaching and high factor loading item, 'On the whole I am satisfied with myself' will be used (1-4 point Likert scale).
Change in Scale to Assess Therapeutic Relationship (STAR; Mcguire-Snieckus et al., 2007)
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).
Change in Satisfaction with the physical environment of the inpatient unit
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)
Change in Satisfaction with the rooms on the inpatient unit
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)
Semi structured interviews
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.

Secondary Outcome Measures

Full Information

First Posted
October 26, 2016
Last Updated
March 4, 2019
Sponsor
Centre for Addiction and Mental Health
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1. Study Identification

Unique Protocol Identification Number
NCT02950571
Brief Title
RCT Examining the Effectiveness of Digital Picture Frame Use in Inpatient Setting
Official Title
A Randomized Controlled Trial Examining the Effectiveness of Digital Picture Frame Use on the Long Term Inpatient Experience
Study Type
Interventional

2. Study Status

Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
October 2016 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Centre for Addiction and Mental Health

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Psychosis, Psychosis NOS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
33 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard Care
Arm Type
Active Comparator
Arm Description
Routine care is comprised of a high level of support from an interdisciplinary team with access to unit-specific and centralized programming
Arm Title
Digital Picture Frames
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Digital Picture Frame
Intervention Description
The intervention is the provision of digital picture frames in long stay inpatient rooms in a ward at CAMH.
Intervention Type
Behavioral
Intervention Name(s)
Standard Care
Intervention Description
High level of support from an interdisciplinary team.
Primary Outcome Measure Information:
Title
Change in Recovery Self Assessment (RSA; O'Connell et al., 2005)
Description
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).
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Client Satisfaction Questionnaire-8 (CSQ-8; Attkisson et al., 1995)
Description
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.
Time Frame
After 4 weeks (post intervention)
Title
Change in Empowerment Scale (Rogers et al., 1997)
Description
Measures dimensions of self efficacy, self stigma and self concept (1-9 point Likert scale).
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Change in Modified Engulfment Scale (McCay & Seeman, 1998)
Description
Only two items from this measure focussing specifically on self-concept will be used (1-5 point Likert scale).
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Change in Rosenberg Self-Esteem Scale (Rosenberg, 1965)
Description
The broadest reaching and high factor loading item, 'On the whole I am satisfied with myself' will be used (1-4 point Likert scale).
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Change in Scale to Assess Therapeutic Relationship (STAR; Mcguire-Snieckus et al., 2007)
Description
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).
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Change in Satisfaction with the physical environment of the inpatient unit
Description
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)
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Change in Satisfaction with the rooms on the inpatient unit
Description
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)
Time Frame
Baseline and after 4 weeks (post intervention)
Title
Semi structured interviews
Description
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.
Time Frame
After 4 weeks (post intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sean A Kidd, PhD
Organizational Affiliation
Centre for Addiction and Mental Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Addiction and Mental Health
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5T 1R8
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
15895922
Citation
O'Connell M, Tondora J, Croog G, Evans A, Davidson L. From rhetoric to routine: assessing perceptions of recovery-oriented practices in a state mental health and addiction system. Psychiatr Rehabil J. 2005 Spring;28(4):378-86. doi: 10.2975/28.2005.378.386.
Results Reference
background
Citation
Attkisson, C. C., & Greenfield, T. K. (1995). The Client Satisfaction Questionnaire (CSQ) scales. Outcome assessment in clinical practice. Baltimore, MD: Williams & Wilkins, 2-10.
Results Reference
background
PubMed Identifier
9255837
Citation
Rogers ES, Chamberlin J, Ellison ML, Crean T. A consumer-constructed scale to measure empowerment among users of mental health services. Psychiatr Serv. 1997 Aug;48(8):1042-7. doi: 10.1176/ps.48.8.1042.
Results Reference
background
PubMed Identifier
9489173
Citation
McCay EA, Seeman MV. A scale to measure the impact of a schizophrenic illness on an individual's self-concept. Arch Psychiatr Nurs. 1998 Feb;12(1):41-9. doi: 10.1016/s0883-9417(98)80007-1.
Results Reference
background
Citation
Rosenberg, M. (1965). Rosenberg self-esteem scale (RSE). Acceptance and commitment therapy. Measures package, 61.
Results Reference
background
PubMed Identifier
17094819
Citation
McGuire-Snieckus R, McCabe R, Catty J, Hansson L, Priebe S. A new scale to assess the therapeutic relationship in community mental health care: STAR. Psychol Med. 2007 Jan;37(1):85-95. doi: 10.1017/S0033291706009299. Epub 2006 Nov 9.
Results Reference
background
Links:
URL
http://www.camh.ca/en/research/Pages/research.aspx
Description
Information about research at the Centre for Addiction and Mental Health, Canada's largest mental health and addictions teachings hospital.

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

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