Social Wellness Through Engagement in a Creative ProcessARTS-REHABNCT02374658
The ARTS-REHAB Project Research Study
A study testing Living Through the Arts Intervetion in people with Social Wellness Through Engagement in a Creative Process and Patient Engagement, run by The Royal Conservatory of Music at 1 site in Canada.
Trial summary
The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative process might impact inpatients in rehabilitation centres. Participants in this random control trial study will be recruited from a slow-stream rehabilitation patient population. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Social Wellness Through Engagement in a Creative Process, Patient Engagement
- What is being tested?
- Living Through the Arts Intervetion
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteCanada
- Study dates
- Feb 2015to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Eligible participants must be health care centre inpatients with an average expected length of stay of 30 days or longer;
- Eligible participants need to be able to speak, understand, and write English; eligible participants also need to be cognitively able to understand and give written consent and complete research questionnaires (either independently or with minimal assistance);
- Eligible participants are willing and able to take part in either the intervention group (Living Through the Arts programming) or in the control group;
- Eligible participants were either community-dwelling or have had a short stay in acute care (no longer than 4 weeks) prior to admission;
- Eligible participants who are anticipated to return to their homes/communities (or to continue with their rehabilitation as outpatients) following their reconditioning rehabilitation.
Who cannot join
- early patient discharge (prior to the completion of minimum number of 4 sessions);
- inability of patient to complete questionnaires (due to physical pain or cognitive decline);
- transfer of patient to acute care (without return to slow-stream rehabilitation); and
- (anticipated) transfer of patient to long-term care following rehabilitation.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
The Royal Conservatoy of Music
Toronto, Ontario, M5V 1W2
Lisa Meschino, PhD
About this study
Official title: The Royal Conservatory's ARTS-REHAB Project Research Study
The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative process might impact inpatients in rehabilitation centres. Participants in this random control trial study will be recruited from a slow-stream rehabilitation patient population. The study intervention will consist of The Royal Conservatory's Living Through the Arts program. Data will be collected using structured and semi-structured questionnaires along with observational logs and focus groups. This study will explore the effects of the program, comparing the intervention and control group participants' sense of hope and optimism for returning to their daily lives, as well as their sense of engagement in their physical recovery.
Read the detailed description
The question to be answered through the proposed ARTS-REHAB Project Research Study is: how can meaningful engagement in a creative arts program impact the personal and social wellness of patients in rehabilitation? The ARTS-REHAB Project is a random control trial study that aims to describe and interpret the expectations and experiences of patients' evolving sense of self in recovery as informed by their participation in The Royal Conservatory's Living Through the Arts program. Living Through the Arts is an inter-arts program designed to empower individuals and communities through artistic self-expression and creativity. For those patients receiving this arts intervention in addition to their rehabilitation activities, we expect to see a difference in the following primary measures of their evolving sense of self in recovery compared to patients in a control group. That is, we expect to find an increased sense of hope and optimism; increased sense of future purpose; as well as increased engagement in their rehabilitation. In addition, we will also explore potential attending benefit of functional improvements through a measure of an anticipated decrease in patients' length of hospital stay. Given the complexity of the ARTS-REHAB Project, the study is being conducted in two phases: Phase 1 (now completed) was an 8-week pilot study, conducted at West Park Healthcare Centre and Bridgepoint Active Healthcare between July and October 2014. This pilot evaluated strictly the operational feasibility of implementing an arts program and collecting data with a slow-stream rehabilitation patient population. Phase 2 expands on the learning from the pilot study and involves a two-and-a-half-year Random Control Trial (RTC) study with a total of 8 hospitals (including St. Peter's Hospital in Hamilton, four Toronto hospitals, and 3 other hospitals from across the province). Unlike the pilot study of feasibility, the focus of the two-and-a-half-year study is on the research measures of personal and social wellness described above.
As an extension of a growing literature on arts and healthcare, the proposed research contributes to the knowledge of the transformative potential of creative arts programs / interventions in healthcare settings. Perceptual psychologist Rudolph Arnheim wrote that, "by demonstrating what it can do for the distressed, art reminds us what it is meant to do for everybody" (Arnheim,1986, p. 257). Arnheim's observation aptly captures the spirit of the literature on the contributions of creative arts to the health of individuals with illness and disability (Daykin, Byrne, Soteriou, \& Sullivan-Marx, 2006 for review; McNiff, 2009; Malchiodi, ed., 2000; Moon, 2008). However, much of this literature focuses on specific art forms as medical therapy for specific illnesses (e.g., dementia, schizophrenia) and specific demographics (seniors, children). There appears to be a need for studies that examine more broadly how engagement in a creative process serves the whole person and not strictly the disability during recovery / treatment. The ARTS-REHAB Project Research Study takes up this approach by exploring recovery not only in terms of patients' physical needs, but also in terms of their emotional and psychological needs for healing and returning to their daily lives and communities.
Given the "whole person" approach of this study, the degree of a patient's engagement in their recovery must be considered. A diverse literature on patient motivation and compliance has shown that patient engagement can play a role in determining the success of their treatment (O'Gorman, 1975; Meichenbaum \& Turk, 1987 for review; McClean \& Pound, 2000; Skolasky, et al., 2008). Building on this literature, the proposed study will examine the influence of participation in the arts intervention on patients' motivation and perseverance in their rehabilitation treatment.
A third body of literature relevant to this study explores psycho-social indicators of wellbeing in illness/recovery. Within that broad literature, the concept of optimism emerges as playing an important role in coping with stressful life events. Optimism is characterized by an orientation toward the future where positive explanations are offered even for negative outcomes. Simply put, it is the general expectation that good rather than bad will happen (Sheier \& Carver, 1985). According to the literature, optimism has been associated with improved quality of life in the form of lower anxiety/depression for cancer patients (Carver, Pozo, Harris, 1993; Applebaum et al, 2014) and patients with traumatic brain injury (Peleg, et al., 2009), greater satisfaction with a treatment regime for patients suffering myocardial infarction (Barry, et al., 2007), and lower suicidal ideation for university students (Range \& Penton, 1994). Much of the optimism literature, however, tends to focus on patients with traumatic chronic illness or mental illness (Eisner, et al., 2009; Johnson, et al., 2009). There is room to build on the evidence with a different patient population, namely, patients undergoing physical rehabilitation. Furthermore, there is room to explore optimism in the context of a specifically arts-based intervention, over and above the prescribed medical treatment.
For the past ten years, the Living Through the Arts program has successfully served different demographic communities (e.g. seniors with dementia, homeless or low income individuals, people with mental illnesses or intellectual disabilities) across Ontario. In keeping with the Living Through the Arts program, the ARTS-REHAB Project will use a variety of art forms and a curriculum of storytelling to help patients in rehabilitation imagine and creatively express their path to recovery in a manner that promotes a strong sense of personal capacity and meaning. More specifically, the curriculum for the ARTS-REHAB Project arts program will consist of themes of health, recovery, and new identities that enable patients to create new stories, shape their sense of purpose, and generate positive images of the future.
The expected outcomes for participants in the arts program of the study include generating: a greater increase in optimism for their recovery; a positive outlook for the future; and a shorter length of stay in hospital when compared to patients who were not involved in the arts program.
- Being tested
- Living Through the Arts Intervetion
- Medical subject headings
- Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Living Through the Arts IntervetionBehavioural
Also called Arts Intervention
A weekly one-hour creative arts program that will engage participants in several different creative processes, including visual art, music, dance, drama, and creative writing.
| Study group | Role | What they receive |
|---|---|---|
| Arts Intervention | Experimental | This group will receive the weekly one-hour Living Through the Arts program in addition to their standard program of rehabilitation activities Receives: Behavioral: Living Through the Arts Intervetion |
| Control Group | No intervention | This group of patients will only receive their standard program of rehabilitation activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hope and optimism measured through pre- and post- program questionnaires
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge.
Measured: 30 - 90 days
Future purpose measured through pre- and post- program questionnaires
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge
Measured: 30 - 90 days
patient engagement measured through pre- and post- program questionnaires
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge
Measured: 30-90 days
Secondary outcomes (1)
Length of stay
Difference scores will be calculated using patient admission and discharge dates (both anticipated and actual discharge dates).
Measured: 30-90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startFeb 2015
- Primary completionApr 2017 (estimated)
- Study completionApr 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Social Wellness Through Engagement in a Creative ProcessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Royal Conservatory of Music
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Trillium Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374658
- Sponsor's protocol ID
- 123123
- Acronym
- ARTS-REHAB
- Status last verified
- Feb 2015
- First submitted
- 23 Feb 2015
- Last updated
- 2 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Royal Conservatory's ARTS-REHAB Project Research Study
- ClinicalTrials.gov ID
- NCT02374658
- Acronym / sponsor ID
- ARTS-REHAB / 123123
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- The Royal Conservatory of MusicUniversity, hospital or other
- Collaborators
- Ontario Trillium Foundation
- Study start
- Feb 2015
- Primary completion
- Apr 2017 (estimated)
- Study completion
- Apr 2017 (estimated)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The ARTS-REHAB Project Research Study examines how meaningful engagement in a creative process might impact inpatients in rehabilitation centres. Participants in this random control trial study will be recruited from a slow-stream rehabilitation patient population. The study intervention will consist of The Royal Conservatory's Living Through the Arts program. Data will be collected using structured and semi-structured questionnaires along with observational logs and focus groups. This study will explore the effects of the program, comparing the intervention and control group participants' sense of hope and optimism for returning to their daily lives, as well as their sense of engagement in their physical recovery.
Detailed description
The question to be answered through the proposed ARTS-REHAB Project Research Study is: how can meaningful engagement in a creative arts program impact the personal and social wellness of patients in rehabilitation? The ARTS-REHAB Project is a random control trial study that aims to describe and interpret the expectations and experiences of patients' evolving sense of self in recovery as informed by their participation in The Royal Conservatory's Living Through the Arts program. Living Through the Arts is an inter-arts program designed to empower individuals and communities through artistic self-expression and creativity. For those patients receiving this arts intervention in addition to their rehabilitation activities, we expect to see a difference in the following primary measures of their evolving sense of self in recovery compared to patients in a control group. That is, we expect to find an increased sense of hope and optimism; increased sense of future purpose; as well as increased engagement in their rehabilitation. In addition, we will also explore potential attending benefit of functional improvements through a measure of an anticipated decrease in patients' length of hospital stay. Given the complexity of the ARTS-REHAB Project, the study is being conducted in two phases: Phase 1 (now completed) was an 8-week pilot study, conducted at West Park Healthcare Centre and Bridgepoint Active Healthcare between July and October 2014. This pilot evaluated strictly the operational feasibility of implementing an arts program and collecting data with a slow-stream rehabilitation patient population. Phase 2 expands on the learning from the pilot study and involves a two-and-a-half-year Random Control Trial (RTC) study with a total of 8 hospitals (including St. Peter's Hospital in Hamilton, four Toronto hospitals, and 3 other hospitals from across the province). Unlike the pilot study of feasibility, the focus of the two-and-a-half-year study is on the research measures of personal and social wellness described above.
As an extension of a growing literature on arts and healthcare, the proposed research contributes to the knowledge of the transformative potential of creative arts programs / interventions in healthcare settings. Perceptual psychologist Rudolph Arnheim wrote that, "by demonstrating what it can do for the distressed, art reminds us what it is meant to do for everybody" (Arnheim,1986, p. 257). Arnheim's observation aptly captures the spirit of the literature on the contributions of creative arts to the health of individuals with illness and disability (Daykin, Byrne, Soteriou, \& Sullivan-Marx, 2006 for review; McNiff, 2009; Malchiodi, ed., 2000; Moon, 2008). However, much of this literature focuses on specific art forms as medical therapy for specific illnesses (e.g., dementia, schizophrenia) and specific demographics (seniors, children). There appears to be a need for studies that examine more broadly how engagement in a creative process serves the whole person and not strictly the disability during recovery / treatment. The ARTS-REHAB Project Research Study takes up this approach by exploring recovery not only in terms of patients' physical needs, but also in terms of their emotional and psychological needs for healing and returning to their daily lives and communities.
Given the "whole person" approach of this study, the degree of a patient's engagement in their recovery must be considered. A diverse literature on patient motivation and compliance has shown that patient engagement can play a role in determining the success of their treatment (O'Gorman, 1975; Meichenbaum \& Turk, 1987 for review; McClean \& Pound, 2000; Skolasky, et al., 2008). Building on this literature, the proposed study will examine the influence of participation in the arts intervention on patients' motivation and perseverance in their rehabilitation treatment.
A third body of literature relevant to this study explores psycho-social indicators of wellbeing in illness/recovery. Within that broad literature, the concept of optimism emerges as playing an important role in coping with stressful life events. Optimism is characterized by an orientation toward the future where positive explanations are offered even for negative outcomes. Simply put, it is the general expectation that good rather than bad will happen (Sheier \& Carver, 1985). According to the literature, optimism has been associated with improved quality of life in the form of lower anxiety/depression for cancer patients (Carver, Pozo, Harris, 1993; Applebaum et al, 2014) and patients with traumatic brain injury (Peleg, et al., 2009), greater satisfaction with a treatment regime for patients suffering myocardial infarction (Barry, et al., 2007), and lower suicidal ideation for university students (Range \& Penton, 1994). Much of the optimism literature, however, tends to focus on patients with traumatic chronic illness or mental illness (Eisner, et al., 2009; Johnson, et al., 2009). There is room to build on the evidence with a different patient population, namely, patients undergoing physical rehabilitation. Furthermore, there is room to explore optimism in the context of a specifically arts-based intervention, over and above the prescribed medical treatment.
For the past ten years, the Living Through the Arts program has successfully served different demographic communities (e.g. seniors with dementia, homeless or low income individuals, people with mental illnesses or intellectual disabilities) across Ontario. In keeping with the Living Through the Arts program, the ARTS-REHAB Project will use a variety of art forms and a curriculum of storytelling to help patients in rehabilitation imagine and creatively express their path to recovery in a manner that promotes a strong sense of personal capacity and meaning. More specifically, the curriculum for the ARTS-REHAB Project arts program will consist of themes of health, recovery, and new identities that enable patients to create new stories, shape their sense of purpose, and generate positive images of the future.
The expected outcomes for participants in the arts program of the study include generating: a greater increase in optimism for their recovery; a positive outlook for the future; and a shorter length of stay in hospital when compared to patients who were not involved in the arts program.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arts Intervention | Experimental | Behavioral: Living Through the Arts IntervetionThis group will receive the weekly one-hour Living Through the Arts program in addition to their standard program of rehabilitation activities |
| Control Group | No intervention | –This group of patients will only receive their standard program of rehabilitation activities |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Eligible participants must be health care centre inpatients with an average expected length of stay of 30 days or longer;
- Eligible participants need to be able to speak, understand, and write English; eligible participants also need to be cognitively able to understand and give written consent and complete research questionnaires (either independently or with minimal assistance);
- Eligible participants are willing and able to take part in either the intervention group (Living Through the Arts programming) or in the control group;
- Eligible participants were either community-dwelling or have had a short stay in acute care (no longer than 4 weeks) prior to admission;
- Eligible participants who are anticipated to return to their homes/communities (or to continue with their rehabilitation as outpatients) following their reconditioning rehabilitation.
Key exclusion criteria (4 listed)
- early patient discharge (prior to the completion of minimum number of 4 sessions);
- inability of patient to complete questionnaires (due to physical pain or cognitive decline);
- transfer of patient to acute care (without return to slow-stream rehabilitation); and
- (anticipated) transfer of patient to long-term care following rehabilitation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Living Through the Arts IntervetionAlso: Arts InterventionA weekly one-hour creative arts program that will engage participants in several different creative processes, including visual art, music, dance, drama, and creative writing. | Behavioural | Arts Intervention |
Primary outcome
Hope and optimism measured through pre- and post- program questionnaires
Time frame: 30 - 90 days
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge.
Future purpose measured through pre- and post- program questionnaires
Time frame: 30 - 90 days
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge
patient engagement measured through pre- and post- program questionnaires
Time frame: 30-90 days
Primary outcome will be measured through pre- and post- program questionnaires administered upon patient intake and prior to patient discharge
1 secondary outcome
Length of stay
Time frame: 30-90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2015.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Living Through the Arts Intervetion in people with Social Wellness Through Engagement in a Creative Process and Patient Engagement, run by The Royal Conservatory of Music at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lisa Meschino, PhD (647-340-0092, lisa.meschino@rcmusic.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hope and optimism measured through pre- and post- program questionnaires (time frame: 30 - 90 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2015.