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Meaning-Based Approach for Alzheimer's
N/A
Recruiting
Led By Anne Bourbonnais
Research Sponsored by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Older people: having a life expectancy of less than three months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 4 months (follow-up)
Awards & highlights
No Placebo-Only Group
Summary
This trial aims to reduce vocal behaviours (VB) in older people with Alzheimer's disease living in long-term care facilities, which may indicate ill-being and disturb others. A new approach was developed based on finding the underlying reasons for VB through a partnership between family and formal caregivers. The goals are to reduce VB, enhance older people's well-being, and increase family and formal caregivers' empowerment.
Who is the study for?
This trial is for older individuals (65+) with Alzheimer's or related disorders who live in nursing homes, exhibit daily vocal behaviors, and have a family caregiver visiting at least twice a month. It also includes these caregivers and health professionals involved in the care of the older person three times per week.
What is being tested?
The study tests an approach to understand and address vocal behaviors like moaning or calling out in elderly people with Alzheimer's living in nursing homes. Half of the facilities will use this new method while the other half continue usual practices, comparing results over four months.
What are the potential side effects?
Since this intervention involves non-medical approaches focusing on understanding behavior through caregiver partnerships, there are no direct medical side effects expected from participating in this trial.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My doctor expects I have less than three months to live.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 4 months (follow-up)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~4 months (follow-up)
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change from baseline frequency of vocal behaviors
Secondary study objectives
Voice Disorders
Change from baseline in empowerment-family caregivers
Change from baseline in empowerment-formal caregivers
+9 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Experimental groupExperimental Treatment1 Intervention
Approach based on the meanings of vocal behaviours
Group II: Control groupActive Control1 Intervention
Usual practices of formal caregivers regarding vocal behaviours
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Who is running the clinical trial?
Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealLead Sponsor
23 Previous Clinical Trials
8,596 Total Patients Enrolled
Anne BourbonnaisPrincipal InvestigatorCentre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am a nurse or health professional caring for an older person at least three times a week.I visit and support an older person regularly and speak English or French.I am 65 or older with Alzheimer's, show daily vocal behaviors, and have a family caregiver.My doctor expects I have less than three months to live.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental group
- Group 2: Control group
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.