NCT03506672Completed
Assessing the Effectiveness of an Approach for Vocal Behaviors in Older People Living in Nursing Homes
Assessing the Effectiveness of an Approach Based on the Meanings of Vocal Behaviours in Older People Living With Alzheimer's Disease in Long-term Care Facilities: DECIBELS Project
Source: ClinicalTrials.gov · Last updated 25 Apr 2025
Brief summary (registry, in English)
Between 13 and 60% of older people who live with Alzheimer's disease (ADRD) in long-term care facilities (LTCFs) manifest vocal behaviours (VB) that may seem inappropriate, e.g. moaning, screaming, calling out. These behaviours may indicate ill-being, disturb others, create feelings of powerlessness in family and formal caregivers, and lead to inappropriate medication. Previous efforts to reduce VB have been largely ineffective. 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. The approach was tested in a pilot study of 14 triads comprising an older person living with ADRD, a family caregiver and a formal caregiver. The results were promising; overall, it is feasible to implement the approach in LTCF and it has positive effects on older people, family and formal caregivers. Now the investigators propose to assess the clinical and economic impact of the approach in 20 LTCFs with 108 triads like those in the pilot study. The approach will be implemented in 10 randomly selected "experimental" LTCFs; the other 10 (control group) will continue with their usual practices. The investigators will measure VB frequency and the well-being of the older people before, two and four months after starting the implementation. They will also measure the perceived disruptiveness of VB for family and formal caregivers, their ability to work in partnership and their empowerment relative to VB. The investigators will compare data between the control and experimental LTCFs, and calculate cost-effectiveness based on changes in VB frequency. The proposed three-year project aims to improve the well-being of all involved in LTCF by promoting a better understanding of VB and implementing a solution to optimize care. The investigators believe the findings will provide evidence to justify the wider implementation of the approach in LTCF.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 157 (actual)
- First submitted
- 9 Apr 2018
- Start date
- 30 Nov 2018
- Primary completion date
- 17 Apr 2025
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Diseases
- Alzheimer disease
- NCT number
- NCT03506672
What you commit to
- Study type: Interventional
- Participants enrolled: 157
- From 30 Nov 2018 to the primary completion date, 17 Apr 2025
- 7 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Older people: having a life expectancy of less than three months
- Family caregivers: N/A
- Formal caregivers: having already participated in the trial for another older person.
Who the study is looking for
- Older people: being 65 years old or more, having a diagnostic of Alzheimer's disease or related disorders, manifesting vocal behaviours daily and having contact with a family caregiver.
- Family caregivers: being a person that has an emotional and social relation with the older person, visiting her/him at least twice a month, speaking English or French.
- Formal caregivers: being a registered nurse (RN), licensed practical nurse (LPN), nurses' aide (NA) or another health professional involved at least three times per week in the care of the older person, speaking English or French.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHSLD Laval et Riviera Coordinator of this site? Confirm its status | Laval | Canada | Unknown status |
| Vigi Santé Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Résidence Berthiaume-du-Tremblay Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS Centre-Sud-de-l'Île-de-Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS Nord-de-l'Île-de-Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| CIUSSS Ouest-de-l'Île-de-Montréal Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
| Residence Angelica Coordinator of this site? Confirm its status | Montreal | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.