Meaning-Based Approach for Alzheimer's

Recruiting at 6 trial locations

Overseen By Anne Bourbonnais

Age: 18+

Sex: Any

Trial Phase: Academic

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

Disqualifiers: Life expectancy less than three months

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

157 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial protocol does not specify whether participants must stop taking their current medications.

What data supports the effectiveness of this treatment for Alzheimer's?

Research shows that nonverbal communication, like vocal behaviors, can be meaningful and improve interactions with people with Alzheimer's. Coaching strategies for caregivers have also been effective in reducing negative behaviors and improving communication, suggesting that non-pharmacological approaches focusing on vocal behaviors can be beneficial. ^{1 2 3 4 5}

Is the Meaning-Based Approach for Alzheimer's safe for humans?

The research does not provide specific safety data for the Meaning-Based Approach for Alzheimer's or similar interventions, but it discusses non-drug methods like 'redirection' for managing vocal behaviors in dementia, which are generally considered safe and aim to reduce caregiver distress. ^{6 7 8 9 10}

How is the Meaning-Based Approach for Alzheimer's treatment different from other treatments?

This treatment is unique because it focuses on understanding and responding to the meanings behind vocal behaviors in Alzheimer's patients, rather than using medication. It emphasizes the importance of treating non-verbal vocalizations as meaningful communication, which can improve interactions and the well-being of both patients and caregivers. ^{1 4 10 11 12}

Research Team

Anne Bourbonnais

Principal Investigator

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

Eligibility Criteria

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.

Inclusion Criteria

I am a nurse or health professional caring for an older person at least three times a week.

I am 65 or older with Alzheimer's, show daily vocal behaviors, and have a family caregiver.

Exclusion Criteria

Family caregivers: N/A

My doctor expects I have less than three months to live.

Formal caregivers: having already participated in the trial for another older person

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

The approach based on the meanings of vocal behaviours is implemented in experimental LTCFs

2 months

Regular meetings (at least monthly)

Follow-up

Participants are monitored for changes in vocal behaviours and well-being

4 months

Qualitative Component

Qualitative data collection through semi-structured interviews to describe process elements

Treatment Details

Interventions

• Approach based on the meanings of vocal behaviours
• Usual practices

Trial Overview 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.

Participant Groups

Group I: Experimental group Experimental Treatment 1 Intervention

Approach based on the meanings of vocal behaviours

Group II: Control group Active Control 1 Intervention

Usual practices of formal caregivers regarding vocal behaviours

Who Is Running the Clinical Trial?

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

Lead Sponsor

Trials

26

Recruited

9,500+

Findings from Research

In a study analyzing nonverbal vocalizations of a participant with late-stage dementia, it was found that these vocalizations have a singing-like quality and do not match the intonation of the participant's verbal speech, suggesting a unique form of communication.

The study highlights that nonverbal vocalizations should be recognized as meaningful contributions in clinical settings, as they can be perceived by others as significant communicative acts, rather than merely disruptive behavior.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intonational patterns of nonverbal vocalizations in people with dementia. Samuelsson, C., Hydén, LC.[2011]

A 6-week coaching strategy for certified nursing assistants (CNAs) led to a significant increase in positive communication behaviors when interacting with people with dementia, suggesting that targeted training can enhance caregiver interactions.

The study also found a significant decrease in negative responsive behaviors (like yelling or hitting) among people with dementia after the coaching, indicating that improved communication may help reduce agitation and improve overall care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Positive Changes in Certified Nursing Assistants' Communication Behaviors With People With Dementia: Feasibility of a Coaching Strategy. Douglas, NF., MacPherson, MK.[2021]

The Natural Language Paradigm (NLP) effectively increased appropriate verbalizations in older adults with cognitive impairments, as demonstrated in a study involving three participants at a leisure-based adult day program.

Participants not only showed an increase in appropriate speech during NLP sessions, but those with higher levels of inappropriate vocalizations also experienced a decrease in such speech, suggesting NLP may help improve overall communication skills.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using the Natural Language Paradigm (NLP) to increase vocalizations of older adults with cognitive impairments. Leblanc, LA., Geiger, KB., Sautter, RA., et al.[2020]

Non-verbal communication remains effective in individuals with Alzheimer's disease, even in late stages, as patients continue to produce and respond to non-verbal signals like gestures and facial expressions.

Enhancing understanding and interpretation of non-verbal behaviors can significantly improve interactions, leading to better physical and psychological well-being for both patients and caregivers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Non-verbal communication in Alzheimer's disease]. Schiaratura, LT.[2008]

A 12-month automated interactive voice response (IVR) intervention significantly reduced caregiver anxiety, depression, and feelings of being bothered by caregiving duties, particularly for those with lower mastery at baseline, in a study of 100 caregivers.

Wives of individuals with Alzheimer's disease showed notable improvements in their caregiving experience, indicating that tailored interventions can effectively support caregivers based on their specific needs and characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. Mahoney, DF., Tarlow, BJ., Jones, RN.[2022]

A case study of a 78-year-old woman with mixed dementia showed that using a redirection technique effectively reduced her vocalizations, which were linked to anxiety and agitation.

Nonpharmacological approaches like redirection are recommended as first-line therapies for managing negative behavioral and psychological symptoms of dementia, as they can alleviate symptoms without the side effects associated with psychotropic medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Vocalization in dementia: a case report and review of the literature. Yusupov, A., Galvin, JE.[2021]

Elderspeak, or infantilizing communication, used by nursing home staff significantly increases the likelihood of resistiveness to care (RTC) in older adults with dementia, leading to negative vocalizations such as screaming or crying.

Reducing the use of elderspeak by staff may help decrease these disruptive behaviors, thereby improving the quality of nursing care for residents with dementia.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Elderspeak's influence on resistiveness to care: focus on behavioral events. Herman, RE., Williams, KN.[2021]

Vocally disruptive behavior (VDB) in nursing home patients is linked to various factors such as depression, anxiety, severe dementia, and communication difficulties, indicating a complex interplay of mental health and cognitive issues.

The study suggests that referrals for treatment of VDB may be more influenced by the stress and emotional distress experienced by nursing staff rather than the specific characteristics of the disruptive behavior itself.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Case-controlled study of nursing home residents referred for treatment of vocally disruptive behavior. Draper, B., Snowdon, J., Meares, S., et al.[2022]

The review identified only eight studies on persistent vocalizations (PVs) in nursing home residents with dementia, highlighting a significant gap in research on this issue.

The studies varied widely in their definitions and methods for measuring PVs, which limits the ability to make clear recommendations for clinical practice and indicates a need for more standardized research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrative review: Persistent vocalizations among nursing home residents with dementia. Sefcik, JS., Ersek, M., Hartnett, SC., et al.[2023]

Noise-making in later stages of Alzheimer's disease can be somewhat responsive to ongoing interactions, suggesting that these sounds may not be entirely random or meaningless.

Co-participants often interpret the noise-making as meaningful, indicating that treating these utterances as significant can enhance communication and understanding among individuals involved.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Non-verbal vocalizations, dementia and social interaction. Hydén, LC.[2012]

Patients with moderately severe Alzheimer's disease showed a significant decrease in the quantity and quality of verbal communication compared to healthy adults, but they consistently produced gestures during interactions.

The study suggests that gestures, particularly representational ones, may help compensate for speech deficits in Alzheimer's patients, highlighting their crucial role in maintaining interpersonal communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Verbal and gestural communication in interpersonal interaction with Alzheimer's disease patients]. Schiaratura, LT., Di Pastena, A., Askevis-Leherpeux, F., et al.[2016]

In a study analyzing mealtime interactions of five institutionalized Alzheimer’s patients, it was found that these individuals possess significant nonverbal communication skills that aid in their interaction with caregivers during meals.

The research identified specific behavioral factors that can either hinder or enhance the mealtime experience for patients with dementia, highlighting the importance of understanding these dynamics for better care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Eating and drinking in patients with Alzheimer dementia. A study of interactions]. Wagener, R., Berkemeyer, C., Hock, G., et al.[2006]

References

1. United States pubmed.ncbi.nlm.nih.gov

Intonational patterns of nonverbal vocalizations in people with dementia. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

Positive Changes in Certified Nursing Assistants' Communication Behaviors With People With Dementia: Feasibility of a Coaching Strategy. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Using the Natural Language Paradigm (NLP) to increase vocalizations of older adults with cognitive impairments. [2020]

4. France pubmed.ncbi.nlm.nih.gov

[Non-verbal communication in Alzheimer's disease]. [2008]

5. United States pubmed.ncbi.nlm.nih.gov

Effects of an automated telephone support system on caregiver burden and anxiety: findings from the REACH for TLC intervention study. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Vocalization in dementia: a case report and review of the literature. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Elderspeak's influence on resistiveness to care: focus on behavioral events. [2021]

8. England pubmed.ncbi.nlm.nih.gov

Case-controlled study of nursing home residents referred for treatment of vocally disruptive behavior. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Integrative review: Persistent vocalizations among nursing home residents with dementia. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Non-verbal vocalizations, dementia and social interaction. [2012]

11. France pubmed.ncbi.nlm.nih.gov

[Verbal and gestural communication in interpersonal interaction with Alzheimer's disease patients]. [2016]

12. Switzerland pubmed.ncbi.nlm.nih.gov

[Eating and drinking in patients with Alzheimer dementia. A study of interactions]. [2006]