Main
|
Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
|
ClinicalTrials.gov |
Last refreshed on:
|
16 December 2017 |
Main ID: |
NCT03080870 |
Date of registration:
|
21/02/2017 |
Prospective Registration:
|
Yes |
Primary sponsor: |
|
Public title:
|
JOYof ART - an Intervention Study
JOYofART |
Scientific title:
|
JOY of ART - an Intervention Study for Older Adults and Their Family Caregivers |
Date of first enrolment:
|
March 3, 2017 |
Target sample size:
|
120 |
Recruitment status: |
Recruiting |
URL:
|
https://clinicaltrials.gov/show/NCT03080870 |
Study type:
|
Interventional |
Study design:
|
Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Supportive Care. Masking: None (Open Label).
|
Phase:
|
N/A
|
|
Countries of recruitment
|
Finland
| | | | | | | |
Contacts
|
Name:
|
Tarja Välimäki, PhD |
Address:
|
|
Telephone:
|
+358403552267 |
Email:
|
tarja.valimaki@uef.fi |
Affiliation:
|
|
|
Name:
|
Tarja Välimäki, PhD |
Address:
|
|
Telephone:
|
+358403552267 |
Email:
|
tarja.valimaki@uef.fi |
Affiliation:
|
|
| |
Key inclusion & exclusion criteria
|
Inclusion Criteria:
- 65+ age, family caregiving dyad, ability to walk independently or assisted, home
dwelling
Exclusion Criteria:
- severe dementia, severe aphasia
Age minimum:
65 Years
Age maximum:
N/A
Gender:
All
|
Health Condition(s) or Problem(s) studied
|
Quality of Life
|
Family Caregivers
|
Intervention(s)
|
Other: Art
|
Primary Outcome(s)
|
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]
|
Secondary Outcome(s)
|
Quality of Life assessed using EQ- 5D-5L
[Time Frame: Change in Quality of Life 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]
|
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]
|
Mobility and Balance assessed using Timed up & Go (TUG)
[Time Frame: Change in Mobility and Balance from baseline until three month follow-up]
|
Secondary ID(s)
|
JOYof ART
|
Source(s) of Monetary Support
|
Please refer to primary and secondary sponsors
|
Results
|
Results available:
|
|
Date Posted:
|
|
Date Completed:
|
|
URL:
|
|
|
|