- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03080870
JOYof ART - an Intervention Study (JOYofART)
JOY of ART - an Intervention Study for Older Adults and Their Family Caregivers
Study Overview
Detailed Description
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Kuopio, Finland, 70211
- Recruiting
- University of Eastern Finland
-
Contact:
- Tarja Välimäki, PhD
- Phone Number: +358403552267
- Email: tarja.valimaki@uef.fi
-
Contact:
- Timo Lakka, PhD
- Phone Number: +358407707329
- Email: timo.lakka@uef.fi
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 65+ age, family caregiving dyad, ability to walk independently or assisted, home dwelling
Exclusion Criteria:
- severe dementia, severe aphasia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention
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. |
Multicomponent art intervention
|
|
No Intervention: Control
Baseline and follow-up measurements.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
|
Change in Mental Well-being from baseline until three month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Mobility and Balance assessed using Timed up & Go (TUG)
Time Frame: Change in Mobility and Balance from baseline until three month follow-up
|
Timed up & Go (TUG)
|
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
|
Short Physical Performance Battery (SPPB)
|
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
|
EQ- 5D-5L
|
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
|
General Health Questionnaire (GHQ 12)
|
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
|
Questionnaire on Social and Health Care service use
|
Change in use of Social and Health Care Service use from baseline until three month follow-up
|
Collaborators and Investigators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- JOYof ART
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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