Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline (GIA)
Primary Purpose
Cognitive Impairment
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Painting Sessions
Sponsored by

About this trial
This is an interventional other trial for Cognitive Impairment focused on measuring older adults, cognitive impairment, art therapy, hospital
Eligibility Criteria
Inclusion Criteria:
- Age of 65 years and older
- Cognitive impairment corresponding to a dementia from mild to severe stage, regardless the sitology. The cognitive impairment is passed on a previous Mini Mental status Examination score of 26 or less
- Admission in medicals ward od Division of Geriatrics at Jewish General Hospital
- Medically stable patients
Exclusion Criteria:
- Younger than 65 years old
- No cognitive impairment, meaning a previous MMSE score of 27 or higher
- Medically unstable
- Infectious preventive measures
- Bed-bound
- Inability to stay in a sitting position in either a chair or a wheelchair, for a minimum of 30 minutes
Sites / Locations
- Jewish General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control Group( No Painting Sessions)
Intervention Group( Painting Session)
Arm Description
No Geriatric Inclusive Art session.
Painting sessions for participants
Outcomes
Primary Outcome Measures
4-Item Neuropsychological Conditions Measure
Patient's autonomy, behavior, communication, and duty during Geriatric Inclusive Art session.
Secondary Outcome Measures
Change in patient's health conditions associated with number of falls, new acute organ failure during hospitalization, and the number of medication taken by patient.
The information based on medical chart
Full Information
NCT ID
NCT03624387
First Posted
October 30, 2017
Last Updated
February 25, 2019
Sponsor
Jewish General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03624387
Brief Title
Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline
Acronym
GIA
Official Title
Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
December 2018 (Actual)
Study Completion Date
February 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Jewish General Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Geriatric Inclusive Art (GIA) painting activity is a new form of art therapy, which has been adapted for older adults hospitalized in medical wards. GIA painting sessions have been associated with a decrease of in-hospital mortality and length of stay, particularly in patients with cognitive impairment. Preservation of a stable health status as well as functionality in activities of daily living of older inpatients is a primary objective of care management, in order to avoid deconditioning, long hospital stays and related higher costs.
Detailed Description
The introduction of the problem Preservation of a stable health status as well as functionality in activities of daily living of older inpatients is a primary objective of care management, in order to avoid deconditioning, long hospital stays and related higher costs. Geriatric Inclusive Art (GIA) painting sessions have been associated with a decrease of in-hospital mortality and length of stay, particularly in patients with cognitive impairment. A cycle of Geriatric Inclusive Art (GIA) painting sessions could be a complementary and have a synergistic action with usual care provided to older inpatients.
The purpose of the study The overall objective of the study is to examine the effects of Geriatric Inclusive Art (GIA) painting sessions on neuropsychological and health conditions in older inpatients with cognitive impairment (i.e.; from mild to severe dementia) admitted in medical wards of the Division of Geriatrics at the Jewish General Hospital (Montreal, Quebec).
The motivation for this approach Patients with dementia in a hospital setting are highly vulnerable. Prospective studies show higher rate of adverse outcomes including mortality, delirium, and longer hospital stays. There are limited pharmacological treatment options for demented patients with many adverse effects and the possibility of worsening the illness. Thus, non-pharmacological approaches have their place in the treatment of these patients: they should always be prioritized and used in combination with medication if needed. Art therapy has been used as a non-pharmacological approach in different categories of patients.
The general description of the study The study is a clinical trial, single-centered (Jewish General Hospital, Montreal, Quebec), non-randomized, controlled, superiority trial, open, intent-to-treat, with two parallel arms (intervention and control groups), comparative (comparison of two groups of participants: Intervention group which will have GIA painting sessions and control group will have usual care).
This study has been divided into two consecutive periods (i.e.; feasibility and full periods) in order to increase the possibility to show the effects of GIA painting sessions by measuring the right outcomes with the right tools and no lack of power analysis: The feasibility period will last three-months, which will assess the feasibility of measures of outcomes, estimate the magnitude of changes for the primary outcome of the study and the number of sessions needed for a cycle of GIA painting. The full period will consist of the open non-randomized clinical trial to determine effects of GIA painting sessions. This phase will depend on the findings of the feasibility period.
The population recruited in the study, will be older inpatients admitted in medicals wards of Division of Geriatrics at Jewish General Hospital. Inclusion criteria are the following: age of 65 years and older, cognitive impairment corresponding to a dementia from mild to severe stage, regardless the etiology, admission in medicals ward of Division of Geriatrics at Jewish General hospital, medically stable (i.e.; no acute organ failure) patients.
The population will be separated in two groups: Intervention group: participants who will practice GIA painting session, and Control group: participants who will not practice GIA painting sessions. All participants of this group will be matched on Age (± 3 years), sex, reason for admission and cognitive impairment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Impairment
Keywords
older adults, cognitive impairment, art therapy, hospital
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control Group( No Painting Sessions)
Arm Type
No Intervention
Arm Description
No Geriatric Inclusive Art session.
Arm Title
Intervention Group( Painting Session)
Arm Type
Experimental
Arm Description
Painting sessions for participants
Intervention Type
Other
Intervention Name(s)
Painting Sessions
Intervention Description
During the GIA painting session, each participant will be given a white canvas, four brushes and four different colors of painting.Their only instruction will be to cover the white color of the canvas. At the end of each session, the performance of the participants will be evaluated based on their neuropsychological conditions before and after Geriatric Inclusive Art session.
Primary Outcome Measure Information:
Title
4-Item Neuropsychological Conditions Measure
Description
Patient's autonomy, behavior, communication, and duty during Geriatric Inclusive Art session.
Time Frame
One hour of session
Secondary Outcome Measure Information:
Title
Change in patient's health conditions associated with number of falls, new acute organ failure during hospitalization, and the number of medication taken by patient.
Description
The information based on medical chart
Time Frame
Up to 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age of 65 years and older
Cognitive impairment corresponding to a dementia from mild to severe stage, regardless the sitology. The cognitive impairment is passed on a previous Mini Mental status Examination score of 26 or less
Admission in medicals ward od Division of Geriatrics at Jewish General Hospital
Medically stable patients
Exclusion Criteria:
Younger than 65 years old
No cognitive impairment, meaning a previous MMSE score of 27 or higher
Medically unstable
Infectious preventive measures
Bed-bound
Inability to stay in a sitting position in either a chair or a wheelchair, for a minimum of 30 minutes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Olivier Beauchet, MD
Organizational Affiliation
Jewish General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Jewish General Hospital
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H3T 1E2
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline
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