Geriatric DisordersNCT02356042
Effects of Geriatric Inclusive Art Activity in Nursing Home Residents (GIA)
An observational study of Geriatric Disorders, run by University Hospital, Angers at 1 site in France.
Trial summary
The study aimed to compare the changes in health and functional status between nursing home residents practicing GIA activity and a control group of residents, and to examine the changes in residents' abilities to participate in GIA activity. Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Geriatric Disorders
- What is being tested?
- Geriatric inclusive art (GIA) activity
- How many people
- 24 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2014to Jul 2014
- Phase
- Observational
- 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
Study population: Patients were recruited in nursing home.
Who may be able to join
- Being a resident in the nursing home "la Grande Providence" (Nantes - Loire Atlantique, France)
- Ability to answer questions
- Being affiliated to the French health insurance
Who cannot join
- Inability to understand and speak French
- Opposition to the use of information collected for research purposes
Trial locations and contacts
1 site in 1 country.
About this study
The study aimed to compare the changes in health and functional status between nursing home residents practicing GIA activity and a control group of residents, and to examine the changes in residents' abilities to participate in GIA activity.
Read the detailed description
Geriatric inclusive art (GIA) activity is a derived form of art therapy using painting to make older adults aware of their abilities through an improvement of emotional well-being (1). GIA protected against in-hospital mortality in demented older inpatients and has also been associated with shorter length of hospital stay in geriatric inpatients. These GIA-related positive effects suggest that GIA activity may improve health and functional status in the elderly. To date, effects of GIA on health and functional status in nursing home residents have not been examined.
Based on the previous positive effects reported in older inpatients practicing GIA activity, the investigators hypothesized that GIA activity could improve health and/or functional status of nursing homes residents.
- Conditions
- Geriatric Disorders
- Being tested
- Geriatric inclusive art (GIA) activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Geriatric inclusive art (GIA) activityOther
The frequency of GIA sessions in this study was from 1 to 2 per month. The time of a session was around 1 hour 30 minutes. Participants of intervention group benefited GIA activity during a 6-month follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Nursing home residents practicing GIA activity | Not described Receives: Other: Geriatric inclusive art (GIA) activity | |
| Nursing home residents no practicing GIA activity | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in health and functional status measured by a standardized questionnaire
Change in health and functional status was measured by a standardized questionnaire
Measured: This outcome is assessed at baseline and at 6 months
Secondary outcomes (4)
Change in the number of drugs daily taken assessed by a standardized questionnaire
The number of drugs daily taken was assessed by a standardized questionnaire
Measured: This outcome is assessed at baseline and at 6 months
History of falls in the past 6 months assessed by a standardized questionnaire
History of falls was assessed by a standardized questionnaire
Measured: This outcome is assessed at baseline and at 6 months
Have an unscheduled medical consultation assessed by a standardized questionnaire
Unscheduled medical consultation was assessed by a standardized questionnaire
Measured: This outcome is assessed at baseline and at 6 months
Being hospitalized unscheduled manner assessed by a standardized questionnaire
Unscheduled hospitalization was assessed by a standardized questionnaire
Measured: This outcome is assessed at baseline and at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2015 (estimated)
- Study startFeb 2014
- Primary completionJul 2014
- Study completionJul 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Geriatric DisordersStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Collaborators
- Cémavie
- Responsible party
- Sponsor
- Investigators
- Olivier Beauchet, MD, PhD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02356042
- Sponsor's protocol ID
- 2013-42
- Status last verified
- Jan 2015
- First submitted
- 26 Jan 2015
- Last updated
- 5 Feb 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Geriatric Inclusive Art Activity in Nursing Home Residents (GIA)
- ClinicalTrials.gov ID
- NCT02356042
- Acronym / sponsor ID
- 2013-42
- Conditions
- Geriatric Disorders
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Collaborators
- Cémavie
- Study start
- Feb 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 5 Feb 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 study aimed to compare the changes in health and functional status between nursing home residents practicing GIA activity and a control group of residents, and to examine the changes in residents' abilities to participate in GIA activity.
Detailed description
Geriatric inclusive art (GIA) activity is a derived form of art therapy using painting to make older adults aware of their abilities through an improvement of emotional well-being (1). GIA protected against in-hospital mortality in demented older inpatients and has also been associated with shorter length of hospital stay in geriatric inpatients. These GIA-related positive effects suggest that GIA activity may improve health and functional status in the elderly. To date, effects of GIA on health and functional status in nursing home residents have not been examined.
Based on the previous positive effects reported in older inpatients practicing GIA activity, the investigators hypothesized that GIA activity could improve health and/or functional status of nursing homes residents.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nursing home residents practicing GIA activity | – | Other: Geriatric inclusive art (GIA) activity |
| Nursing home residents no practicing GIA activity | – | – |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients were recruited in nursing home.
Key inclusion criteria (3 listed)
- Being a resident in the nursing home "la Grande Providence" (Nantes - Loire Atlantique, France)
- Ability to answer questions
- Being affiliated to the French health insurance
Key exclusion criteria (2 listed)
- Inability to understand and speak French
- Opposition to the use of information collected for research purposes
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 |
|---|---|---|
| Geriatric inclusive art (GIA) activityThe frequency of GIA sessions in this study was from 1 to 2 per month. The time of a session was around 1 hour 30 minutes. Participants of intervention group benefited GIA activity during a 6-month follow-up period. | Other | Nursing home residents practicing GIA activity |
Primary outcome
Change in health and functional status measured by a standardized questionnaire
Time frame: This outcome is assessed at baseline and at 6 months
Change in health and functional status was measured by a standardized questionnaire
4 secondary outcomes
Change in the number of drugs daily taken assessed by a standardized questionnaire
Time frame: This outcome is assessed at baseline and at 6 months
History of falls in the past 6 months assessed by a standardized questionnaire
Time frame: This outcome is assessed at baseline and at 6 months
Have an unscheduled medical consultation assessed by a standardized questionnaire
Time frame: This outcome is assessed at baseline and at 6 months
Being hospitalized unscheduled manner assessed by a standardized questionnaire
Time frame: This outcome is assessed at baseline and at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2015.
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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.
Olivier Beauchet, MD, PhD principal investigator
University Hospital, Angers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Geriatric Disorders, run by University Hospital, Angers at 1 site in France.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 5 Feb 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 France. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in health and functional status measured by a standardized questionnaire (time frame: This outcome is assessed at baseline and at 6 months). 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 5 Feb 2015; AzTrials last refreshed its copy on 8 Nov 2026.