Non-pharmacological Care of Alzheimer's Disease: Benefice of Musical Interventions (MusicAlzheimer)
Primary Purpose
Alzheimer's Disease (AD) and Related Disorders
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Musical intervention
Non-musical (cooking) intervention
Control with no intervention
Sponsored by
About this trial
This is an interventional supportive care trial for Alzheimer's Disease (AD) and Related Disorders
Eligibility Criteria
Inclusion Criteria:
- Older People and francophones living in institutions
- Presenting a cortical degenerative disease
- Male or female
- Age 60 to 99 years
- French Mother tongue
- People enjoying a social security scheme
- Patient Participation Agreement and of the person of trust or his legal representative.
Exclusion Criteria:
- Patients without cortical degenerative disease
- Patients with uncorrected profound hearing loss
- Not affiliated with a social security scheme Patients .
- Patients refusing to participate in the study or with the agreement of the person of trust or his legal representative was not obtained
- Patient protected by law
Sites / Locations
- Chu de Reims
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Musical intervention
Non-musical (cooking) intervention
Control with no intervention
Arm Description
Outcomes
Primary Outcome Measures
Overall score in the Neuropsychiatric Inventory
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02833870
Brief Title
Non-pharmacological Care of Alzheimer's Disease: Benefice of Musical Interventions
Acronym
MusicAlzheimer
Official Title
Non-drug Taken Charge of Alzheimer's Disease: Profit Musical Activities
Study Type
Interventional
2. Study Status
Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
CHU de Reims
4. Oversight
5. Study Description
Brief Summary
Cares of Alzheimer's disease (AD) and related disorders are presenting a real public health challenge. Because of the limited effectiveness of pharmacological treatments, there is a growing interest in care approach based on nonpharmacological treatments, such as musical interventions. Several lines of evidence suggest that musical interventions could improve behaviour, emotion and even cognition in patients with AD. However, very few studies respond to the methodological constraints required for clinical controlled trials carried out in well selected groups of patients. The efficiency of such care approaches is not scientifically proved yet and the impact of musical interventions has rarely been compared to another pleasant intervention, leaving open the question about the specific benefits of music in patients with dementia. The main goal of this research project is to demonstrate short and longer-term efficiencies and the specificity of musical interventions in dementia by investigating their effects not only in patients but also in familial and professional caregivers.
Detailed Description
To generalize previous results showing that non pharmacological therapy based on musical interventions improved emotional state in patients with severe AD to a larger sample of patients and to demonstrate the possible effects on caregivers, the investigators carried out a randomized controlled study with three parallel arms in institutionalized patients with severe AD (study 1) and in patients with mild AD leaving at home (study 2) to compare the impact of two interventions, a musical and a non-musical (cooking), to a control group (without any intervention). The control activity (cooking) was selected because it shares different features with music. Both interventions provide pleasure, are multisensory and may trigger old memories. In addition, both activities can be carried out in groups. A protocol consisting of various selected tests and questionnaires was used to assess the emotional, behavioural and cognitive abilities. Professional and familial caregivers also filled out other questionnaires to assess potential indirect benefits from both interventions on caregiver burnout and familial caregiver burden. Six assessments were proposed, two before, two during and two after interventions (follow-up) to respectively evaluate short and longer-term benefits of both interventions whereas test -retest effects will be controlled. Psychologists in charge to these assessments will be blind in regard to patients' group (musical versus cooking sessions, no intervention). Data were analyzed with methods from social psychology to decode non-verbal behaviours (e.g. visual contact) and emotional indexes in facial and verbal expressions and with methods from classical neuropsychology and from health domain. The collaboration between the two university teams from Lille and the special care unit (Pole EHPAD-USLD in Reims Hospital) provided complementary skills to this project that ensured its feasibility.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease (AD) and Related Disorders
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Musical intervention
Arm Type
Experimental
Arm Title
Non-musical (cooking) intervention
Arm Type
Experimental
Arm Title
Control with no intervention
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Musical intervention
Intervention Type
Behavioral
Intervention Name(s)
Non-musical (cooking) intervention
Intervention Type
Behavioral
Intervention Name(s)
Control with no intervention
Primary Outcome Measure Information:
Title
Overall score in the Neuropsychiatric Inventory
Time Frame
up to 11 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Older People and francophones living in institutions
Presenting a cortical degenerative disease
Male or female
Age 60 to 99 years
French Mother tongue
People enjoying a social security scheme
Patient Participation Agreement and of the person of trust or his legal representative.
Exclusion Criteria:
Patients without cortical degenerative disease
Patients with uncorrected profound hearing loss
Not affiliated with a social security scheme Patients .
Patients refusing to participate in the study or with the agreement of the person of trust or his legal representative was not obtained
Patient protected by law
Facility Information:
Facility Name
Chu de Reims
City
Reims
ZIP/Postal Code
51092
Country
France
12. IPD Sharing Statement
Learn more about this trial
Non-pharmacological Care of Alzheimer's Disease: Benefice of Musical Interventions
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