Meaning-Based Approach for Alzheimer's

No longer recruiting at 12 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to assist people with Alzheimer's in long-term care facilities who often express themselves through sounds like moaning or calling out. The study tests a new approach that interprets the meanings of vocal behaviors, helping caregivers understand the reasons behind these sounds to improve care and reduce vocal behaviors. The trial involves two groups: one will use this new method, while the other will continue usual care practices. This approach may suit older adults with Alzheimer's who make vocal sounds daily and have a family member who visits regularly. The goal is to enhance the quality of life for the older person, their family, and the caregivers. As an unphased trial, this study provides a unique opportunity to contribute to innovative care strategies for Alzheimer's patients.

Will I have to stop taking my current medications?

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

What prior data suggests that this approach is safe for older people with Alzheimer's in long-term care facilities?

Research has shown that non-drug methods can be safe and effective for people with dementia. One study involving 14 groups, each with a person with Alzheimer's and two caregivers, found this new method to be safe, with no harmful events reported. The method focuses on understanding and addressing the reasons behind moaning or calling out, helping to reduce these behaviors without medication. Other studies also support that non-drug treatments like this can manage disruptive behaviors in dementia patients without causing harm. Overall, the treatment appears well-tolerated and safe to try. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the meaning-based approach for Alzheimer's because it offers a fresh perspective by focusing on the meanings of vocal behaviors. Unlike traditional treatments that often rely on medication to manage symptoms, this approach looks at communication as a key factor in care. By understanding and interpreting the meanings behind vocal expressions, caregivers can potentially improve interactions with patients, possibly leading to better emotional and psychological outcomes. This method could transform how we engage with individuals with Alzheimer's, making care more personalized and empathetic.

What evidence suggests that this approach is effective for reducing vocal behaviors in Alzheimer's patients?

This trial will compare a meaning-based approach with usual practices for managing vocal behaviors in people with Alzheimer's. Research has shown that a meaning-based approach can help manage vocal behaviors. Specifically, a small study with 14 participants demonstrated that this method improved well-being and reduced vocal disruptions. The approach involves understanding the reasons behind these vocal behaviors and collaborating with family and caregivers to address them. Early results suggest this method can empower caregivers and enhance care for those in long-term facilities. Although the study is small, the results are promising and may lead to better support for those with Alzheimer's in care settings. ^{1 2 3 6 7}

Who Is on the Research Team?

Anne Bourbonnais

Principal Investigator

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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

Citations

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Assessing the Effectiveness of an Approach for Vocal ... Description. Aim: To assess the clinical and economic effectiveness of an approach based on the meanings of vocal behaviours (VB) in older ...

2. withpower.com withpower.com/trial/phase-behavioral-symptoms-10-2018-0f31e

Meaning-Based Approach for Alzheimer's 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 ...

3. erudit.org erudit.org/en/journals/snahp/2019-v2-n1-snahp05960/1076443ar.pdf

Effects of an Intervention Approach Based on the Meanings ... Effects of an Intervention Approach Based on the Meanings of. Vocal Behaviours in Older People Living with a Major. Neurocognitive Disorder: A Pilot Study.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9397760/

Effects of Nonpharmacological Interventions on Disruptive ... The objective of this review is to determine the effectiveness of nonpharmacological interventions in the management of disruptive vocalisation ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4036439/

Vocalization in Dementia: A Case Report and Review of the ... This report describes a case of vocalizations in moderate to severe Alzheimer's disease and use of 'redirection' as an effective nonpharmacologic means of ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/24026135/

[Effect of a non-pharmacological intervention, Voix d'Or(®), ... The aim of this study was to test the effects of the Voix d'Or(®) program on behavioral and psychological symptoms of dementia (BPSD) in patients with ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1041610224032460

Pharmacological and nonpharmacological approaches to ... This systematic review aims to provide an overview of intervention studies that report outcome measures of disinhibited behaviors in dementia.