Assessing the Effectiveness of an Approach for Vocal Behaviors in Older People Living in Nursing Homes

NCT03506672 | Completed

• 1 other identifier: 156273
• Study Type: interventional
• Target: 157
• Locations: 1 country
• Sites: 7

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.

Conditions

Behavioral Symptoms

Keywords

Behavioral and psychological symptoms of dementia; Psychosocial interventions; Well-being; Long-term care facilities; Family and formal caregivers; Partnership

Outcome Measures

Primary Outcomes (1)

• Change from baseline frequency of vocal behaviors

  Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 7-point Likert scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a high frequency; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 7

  2 months

Secondary Outcomes (20)

• Change from baseline frequency of vocal behaviors to follow-up

  4 months (follow-up)

• Change from baseline in well-being

  2 months

• Change from baseline in well-being

  4 months (follow-up)

• Change from baseline in medication use

  2 months

• Change from baseline in medication use

  4 months (follow-up)

Study Arms (2)

Experimental group

EXPERIMENTAL

Approach based on the meanings of vocal behaviours

Other: Approach based on the meanings of vocal behaviours

Control group

ACTIVE COMPARATOR

Usual practices of formal caregivers regarding vocal behaviours

Other: Usual practices

Interventions

Approach based on the meanings of vocal behaviours OTHER

Systematic problem-solving approach involving reflecting, deciding, planning and acting together (family and formal caregivers to reduce vocal behaviours and to increase everyone's well-being.

Experimental group

Usual practices OTHER

Usual practices of formal caregivers regarding vocal behaviours

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal: lead

Study Sites (7)

CHSLD Laval et Riviera

Laval, Quebec, H3C 3J7, Canada

Location

CIUSSS Nord-de-l'Île-de-Montréal

Montreal, Quebec, H2V 4T4, Canada

Location

Residence Angelica

Montreal, Quebec, H2V 4T4, Canada

Location

CIUSSS Ouest-de-l'Île-de-Montréal

Montreal, Quebec, H3C 3J7, Canada

Location

Résidence Berthiaume-du-Tremblay

Montreal, Quebec, H3C 3J7, Canada

Location

Vigi Santé

Montreal, Quebec, H3C 3J7, Canada

Location

CIUSSS Centre-Sud-de-l'Île-de-Montréal

Montreal, Quebec, Canada

Location

Related Links

• Research website of principal investigator

MeSH Terms

Conditions

Behavioral Symptoms; Behavior

Study Officials

• Anne Bourbonnais

  Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research - Chairholder

Study Record Dates

• First Submitted: April 9, 2018
• First Posted: April 24, 2018
• Study Start: November 30, 2018
• Primary Completion: April 17, 2025
• Study Completion: April 17, 2025
• Last Updated: April 25, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (7)