Quality of LifeJOYofARTNCT03080870
JOYof ART - an Intervention Study
A study testing Art in people with Quality of Life and Family Caregivers, run by University of Eastern Finland at 1 site in Finland.
Trial summary
Music, dance and visual arts are suggested to support health and well-being of older people. Intervention studies, however, are scarce. JOY of ART study investigates the effects of multicomponent art intervention among older people and ther family caregivers. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Quality of Life, Family Caregivers
- What is being tested?
- Art
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteFinland
- Study dates
- 3 Mar 2017to Jan 2018
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- 65+ age, family caregiving dyad, ability to walk independently or assisted, home dwelling
Who cannot join
- severe dementia, severe aphasia
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
University of Eastern Finland
Kuopio, 70211
Tarja Välimäki, PhD, +358403552267, tarja.valimaki@uef.fi
Timo Lakka, PhD, +358407707329, timo.lakka@uef.fi
About this study
Official title: JOY of ART - an Intervention Study for Older Adults and Their Family Caregivers
Music, dance and visual arts are suggested to support health and well-being of older people. Intervention studies, however, are scarce. JOY of ART study investigates the effects of multicomponent art intervention among older people and ther family caregivers.
Read the detailed description
JOY of ART study investigates the effects of group based intervention including music, dance and visual arts. Art sessions are provided once a week in three months period each session takes 60 minutes. Eligible participants are recruited from the City of Kuopio, Finland, total 60 dyads, 30 to intervention group and 30 to control group. Health, physical performance and quality of life assessments are conducted at the baseline and in the end of the intervention. In addition, participants are contacted by phone and interviewed six months after the intervention has completed. For family caregivers qualitative interviews are conducted at the baseline and in the end of the study.
- Conditions
- Quality of Life, Family Caregivers
- Being tested
- Art
- Keywords
- Art intervention, Quality of Life, Well-being, Physical performance, Family caregivers, Older adults
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ArtOther
Multicomponent art intervention
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Art groups are held once a week, each with the duration of 60 minutes. They begin with a 45 minute art intervention and conclude with a 15 minute discussion. The art groups include music, dance and visual arts, which is psychologically, socially, and physically activating. Music has the main emphasis in art intervention. The preferences of the subjects are taken into consideration in art intervention. Art intervention is conducted by trained and experienced art pedagogues.
Art intervention aims to revive previously learned art-related skills, to learn and enhance new skills, and to improve and intensify physiological, emotional, social, motoric, and cognitive abilities. Receives: Other: Art |
| Control | No intervention | Baseline and follow-up measurements. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental Well-being assessed using the Warwick-Edinburgh Mental Well-being scale (WEMWBS)
The Warwick-Edinburgh Mental Well-being scale (WEMWBS)
Measured: Change in Mental Well-being from baseline until three month follow-up
Secondary outcomes (5)
Mobility and Balance assessed using Timed up & Go (TUG)
Timed up \& Go (TUG)
Measured: Change in Mobility and Balance from baseline until three month follow-up
Physical Performance assessed using Short Physical Performance Battery (SPPB)
Short Physical Performance Battery (SPPB)
Measured: Change in Physical Performance from baseline until three month follow-up
Quality of Life assessed using EQ- 5D-5L
EQ- 5D-5L
Measured: Change in Quality of Life from baseline until three month follow-up
Psychological Distress assessed using General Health Questionnaire (GHQ 12)
General Health Questionnaire (GHQ 12)
Measured: Change in Psychological Distress from baseline until three month follow-up
Use of Social and Health Care Services assessed using Questionnaire
Questionnaire on Social and Health Care service use
Measured: Change in use of Social and Health Care Service use from baseline until three month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start3 Mar 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Quality of LifeStudies 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Eastern Finland
- Sponsor type
- University, hospital or other
- Collaborators
- Kuopio Conservatory, Kuopio University Hospital, Savonia University of Applied Sciences
- Responsible party
- Principal investigator, Tarja Välimäki, University of Eastern Finland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080870
- Sponsor's protocol ID
- JOYof ART
- Acronym
- JOYofART
- Status last verified
- Mar 2017
- First submitted
- 21 Feb 2017
- Last updated
- 15 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pohjola H, Vaajoki A, Valimaki T. Art intervention among Finnish older people and their caregivers: Experiences of art pedagogies. Health Soc Care Community. 2020 Sep;28(5):1780-1786. doi: 10.1111/hsc.13003. Epub 2020 Apr 26.
PubMed 32337789
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- JOY of ART - an Intervention Study for Older Adults and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT03080870
- Acronym / sponsor ID
- JOYofART / JOYof ART
- Conditions
- Quality of Life, Family Caregivers
- Keywords
- Art intervention, Quality of Life, Well-being, Physical performance, Family caregivers, Older adults
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of Eastern FinlandUniversity, hospital or other
- Collaborators
- Kuopio Conservatory, Kuopio University Hospital, Savonia University of Applied Sciences
- Study start
- 3 Mar 2017 (actual)
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 15 Mar 2017 (actual)
- 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.
Music, dance and visual arts are suggested to support health and well-being of older people. Intervention studies, however, are scarce. JOY of ART study investigates the effects of multicomponent art intervention among older people and ther family caregivers.
Detailed description
JOY of ART study investigates the effects of group based intervention including music, dance and visual arts. Art sessions are provided once a week in three months period each session takes 60 minutes. Eligible participants are recruited from the City of Kuopio, Finland, total 60 dyads, 30 to intervention group and 30 to control group. Health, physical performance and quality of life assessments are conducted at the baseline and in the end of the intervention. In addition, participants are contacted by phone and interviewed six months after the intervention has completed. For family caregivers qualitative interviews are conducted at the baseline and in the end of the study.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: ArtArt groups are held once a week, each with the duration of 60 minutes. They begin with a 45 minute art intervention and conclude with a 15 minute discussion. The art groups include music, dance and visual arts, which is psychologically, socially, and physically activating. Music has the main emphasis in art intervention. The preferences of the subjects are taken into consideration in art intervention. Art intervention is conducted by trained and experienced art pedagogues. Art intervention aims to revive previously learned art-related skills, to learn and enhance new skills, and to improve and intensify physiological, emotional, social, motoric, and cognitive abilities. |
| Control | No intervention | –Baseline and follow-up measurements. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65+ age, family caregiving dyad, ability to walk independently or assisted, home dwelling
Key exclusion criteria (1 listed)
- severe dementia, severe aphasia
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 |
|---|---|---|
| ArtMulticomponent art intervention | Other | Intervention |
Primary outcome
Mental Well-being assessed using the Warwick-Edinburgh Mental Well-being scale (WEMWBS)
Time frame: Change in Mental Well-being from baseline until three month follow-up
The Warwick-Edinburgh Mental Well-being scale (WEMWBS)
5 secondary outcomes
Mobility and Balance assessed using Timed up & Go (TUG)
Time frame: Change in Mobility and Balance from baseline until three month follow-up
Physical Performance assessed using Short Physical Performance Battery (SPPB)
Time frame: Change in Physical Performance from baseline until three month follow-up
Quality of Life assessed using EQ- 5D-5L
Time frame: Change in Quality of Life from baseline until three month follow-up
Psychological Distress assessed using General Health Questionnaire (GHQ 12)
Time frame: Change in Psychological Distress from baseline until three month follow-up
Use of Social and Health Care Services assessed using Questionnaire
Time frame: Change in use of Social and Health Care Service use from baseline until three month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2017.
- Derived from this study: PubMed 32337789Pohjola H, Vaajoki A, Valimaki T. Art intervention among Finnish older people and their caregivers: Experiences of art pedagogies. Health Soc Care Community. 2020 Sep;28(5):1780-1786. doi: 10.1111/hsc.13003. Epub 2020 Apr 26.
- Individual participant dataSharing planned: No
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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 Art in people with Quality of Life and Family Caregivers, run by University of Eastern Finland at 1 site in Finland.
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 1 inclusion and 1 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 15 Mar 2017. 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 Finland. 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 Tarja Välimäki, PhD (+358403552267, tarja.valimaki@uef.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental Well-being assessed using the Warwick-Edinburgh Mental Well-being scale (WEMWBS) (time frame: Change in Mental Well-being from baseline until three month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03080870, which also lists 1 linked publication.
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 15 Mar 2017.