Clinical trial NCT03506672: Assessing the Effectiveness of an Approach for Vocal Behaviors in Older People Living in Nursing Homes
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Behavioral Symptoms
Keywords: Behavioral and psychological symptoms of dementia
Psychosocial interventions
Well-being
Long-term care facilities
Family and formal caregivers
Partnership
Lead sponsor: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
Sponsor class: OTHER
First posted: 2018-04-24
Enrollment: 157
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: Aim: To assess the clinical and economic effectiveness of an approach based on the meanings of vocal behaviours (VB) in older people living with Alzheimer's disease or related disorders (ADRD) in long-term care facilities (LTCF) using a pragmatic randomized trial complemented by a qualitative component. Background: Vocal behaviours are common in LTCF; 13 to 60% of residents exhibit them. They may indicate ill-being, are associated with overmedication, are disruptive for others, and induce powerlessness in family and formal caregivers. Studies on interventions to reduce VB have shown limited clinical impacts. In previous projects, the investigators developed and pilot tested a novel approach based on the underlying meanings of VB. The systematic approach comprises family-formal caregivers' partnerships which include regular meetings (at least monthly) to identify the meanings behind VB (e.g. pain, anxiety) and to apply personalized interventions (e.g. gardening, humor). A pilot study conducted in five LTCF demonstrated the feasibility and acceptability of the recruitment and data collection methods, as well as the approach implementation using 14 triads, each made up of an older person with ADRD, a family caregiver and a formal caregiver. The approach decreased the frequency of VB, and increased the well-being of the older people with ADRD. The formal and family caregivers perceived the VB as less disruptive, and felt more empowered relative to them. However, the lack of control group precluded measuring effectiveness versus usual practices and costs. Methods: A pragmatic cluster randomized trial will be conducted to assess the effectiveness of the approach based on the results from the pilot study. A concomitant qualitative component will describe process elements that contribute to the measured effects. The investigators will randomize 20 LTCF to either an experimental (approach) or control group (usual practices), and recruit 6 triads in each LTCF for a total of 108 triads (power of 80%, significance 5%, medium effect size and 40% attrition). They will enroll 10 to 20 triads in the qualitative component. They will collect data, before, two (post-implementation) and four months (follow-up) after starting the implementation of the approach, on VB frequency (primary outcome), medication use, well-being of the older people, perceived disruptiveness of the VB, the partnership-based decision-making and the level of empowerment felt by family and formal caregivers. Additionally, they will collect data on the setting (e.g. number of beds, turnover rate), and cost (e.g. trainer, medication). Qualitative data will also be collected with individual semi-structured interviews. The investigators will analyze the effects of the approach using a mixed-model of covariance with baseline measures, and characteristics of participants and settings as covariates. They will also calculate a cost-effectiveness ratio, and do a content analysis of qualitative data. Expected outcomes: This project will provide evidence on the effectiveness of a novel and generalizable approach to increase the well-being of vulnerable older people, as well as family and formal caregivers. If effective, it may be implemented on a larger scale and adapted to other behaviours (e.g. aggressive behaviours), all of which is aligned with recommendations for research in dementia care.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Change from baseline frequency of vocal behaviors
timeFrame: 2 months
Secondary outcomes:
measure: Change from baseline frequency of vocal behaviors to follow-up
timeFrame: 4 months (follow-up)
measure: Change from baseline in well-being
timeFrame: 2 months
measure: Change from baseline in well-being
timeFrame: 4 months (follow-up)
measure: Change from baseline in medication use
timeFrame: 2 months
measure: Change from baseline in medication use
timeFrame: 4 months (follow-up)
measure: Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
timeFrame: 2 months
measure: Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
timeFrame: 4 months (follow-up)
measure: Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
timeFrame: 2 months
measure: Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
timeFrame: 4 months (follow-up)
measure: Change from baseline in partnership-based decision-making-family caregivers' perspective
timeFrame: 2 months
measure: Change from baseline in partnership-based decision-making-family caregivers' perspective
timeFrame: 4 months (follow-up)
measure: Change from baseline in partnership-based decision-making-formal caregivers' perspective
timeFrame: 2 months
measure: Change from baseline in partnership-based decision-making-formal caregivers' perspective
timeFrame: 4 months (follow-up)
measure: Change from baseline in partnership-based decision-making-formal caregivers' attitudes
timeFrame: 2 months
measure: Change from baseline in partnership-based decision-making-formal caregivers' attitude
timeFrame: 4 months (follow-up)
measure: Change from baseline in empowerment-formal caregivers
timeFrame: 2 months
measure: Change from baseline in empowerment-formal caregivers
timeFrame: 4 months (follow-up)
measure: Change from baseline in empowerment-family caregivers
timeFrame: 2 months
measure: Change from baseline in empowerment-family caregivers
timeFrame: 4 months (follow-up)
measure: Cost
timeFrame: 2 months
Other outcomes:
Locations:
city: Laval
country: Canada
facility: CHSLD Laval et Riviera
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS Nord-de-l'Île-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: Residence Angelica
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS Ouest-de-l'Île-de-Montréal
state: Quebec
city: Montréal
country: Canada
facility: Résidence Berthiaume-du-Tremblay
state: Quebec
city: Montréal
country: Canada
facility: Vigi Santé
state: Quebec
city: Montréal
country: Canada
facility: CIUSSS Centre-Sud-de-l'Île-de-Montréal
state: Quebec
Study officials:
affiliation: Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
name: Anne Bourbonnais
role: PRINCIPAL_INVESTIGATOR
References: