Clinical trial NCT03624387: Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline
Official title: Geriatric Inclusive Art: Effects of Painting Sessions on Older In-patients With Cognitive Decline
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Impairment
Keywords: older adults, cognitive impairment, art therapy, hospital
Lead sponsor: Jewish General Hospital
Sponsor class: OTHER
First posted: 2018-08-10
Enrollment: 140
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel Assignment
Primary purpose: OTHER

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: 1. 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.
2. 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).
3. 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.
4. 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.

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

Primary outcomes:
measure: 4-Item Neuropsychological Conditions Measure
timeFrame: One hour of session
Secondary outcomes:
measure: 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.
timeFrame: Up to 6 months
Other outcomes:
Locations:
city: Montréal
country: Canada
facility: Jewish General Hospital
state: Quebec
Study officials:
affiliation: Jewish General Hospital
name: Olivier Beauchet, MD
role: PRINCIPAL_INVESTIGATOR
References: