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

April 23, 2025 updated by: Anne Bourbonnais, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
157

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Laval, Quebec, Canada, H3C 3J7
        • CHSLD Laval et Riviera
      • Montréal, Quebec, Canada, H2V 4T4
        • CIUSSS Nord-de-l'Île-de-Montréal
      • Montréal, Quebec, Canada, H2V 4T4
        • Residence Angelica
      • Montréal, Quebec, Canada, H3C 3J7
        • CIUSSS Ouest-de-l'Île-de-Montréal
      • Montréal, Quebec, Canada, H3C 3J7
        • Résidence Berthiaume-du-Tremblay
      • Montréal, Quebec, Canada, H3C 3J7
        • Vigi Santé
      • Montréal, Quebec, Canada
        • CIUSSS Centre-Sud-de-l'Île-de-Montréal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental group
Approach based on the meanings of vocal behaviours
Other: Approach based on the meanings of vocal behaviours
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.
Active Comparator: Control group
Usual practices of formal caregivers regarding vocal behaviours
Other: Usual practices
Usual practices of formal caregivers regarding vocal behaviours

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change from baseline frequency of vocal behaviors
Time Frame: 2 months
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline frequency of vocal behaviors to follow-up
Time Frame: 4 months (follow-up)
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
4 months (follow-up)
Change from baseline in well-being
Time Frame: 2 months
Quality of Life in Late-Stage Dementia (QUALID); 11 emotional states and activities on a 5-point scale; A low score indicates a better well-being; Average score Min = 11 and Max = 55
2 months
Change from baseline in well-being
Time Frame: 4 months (follow-up)
Quality of Life in Late-Stage Dementia (QUALID); 11 emotional states and activities on a 5-point scale; A low score indicates a better well-being; Average score Min = 11 and Max = 55
4 months (follow-up)
Change from baseline in medication use
Time Frame: 2 months
Medical chart
2 months
Change from baseline in medication use
Time Frame: 4 months (follow-up)
Medical chart
4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
Time Frame: 2 months
Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 5-point disruptiveness scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a significant disruptiveness; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 6
2 months
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
Time Frame: 4 months (follow-up)
Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 5-point disruptiveness scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a significant disruptiveness; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 6
4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
Time Frame: 2 months
Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 5-point disruptiveness scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a significant disruptiveness; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 6
2 months
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
Time Frame: 4 months (follow-up)
Cohen-Mansfield Agitation Inventory (CMAI); 29 behaviours on a 5-point disruptiveness scale. Subscale "verbally agitated behaviours" of 6 items; A high score indicates a significant disruptiveness; For subscale "verbally agitated behaviours": Average score Min = 1 and Max = 6
4 months (follow-up)
Change from baseline in partnership-based decision-making-family caregivers' perspective
Time Frame: 2 months
Family Perception of Caregiving Role (FPCR); 43 items on a 7-point Likert scale with three subscales. The sub-dimension "characteristics of the role" will be used (23 items); The lower the score, the higher is the partnership; For subscale "characteristics of the role": Average score Min = 1 and Max = 7
2 months
Change from baseline in partnership-based decision-making-family caregivers' perspective
Time Frame: 4 months (follow-up)
Family Perception of Caregiving Role (FPCR); 43 items on a 7-point Likert scale with three subscales. The sub-dimension "characteristics of the role" will be used (23 items); The lower the score, the higher is the partnership; For subscale "characteristics of the role": Average score Min = 1 and Max = 7
4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' perspective
Time Frame: 2 months
Staff Perception of Caregiving Role (SPCR) questionnaire; 58 items measured on a 7-point Likert scale. Two subscales, "consequence of interactions" (32 items) and "partnership with the family" (26 items); Each one has a separate score; The lower the score, the higher is the partnership; For each subscale: Average score Min = 1 and Max = 7
2 months
Change from baseline in partnership-based decision-making-formal caregivers' perspective
Time Frame: 4 months (follow-up)
Staff Perception of Caregiving Role (SPCR) questionnaire; 58 items measured on a 7-point Likert scale. Two subscales, "consequence of interactions" (32 items) and "partnership with the family" (26 items); Each one has a separate score; The lower the score, the higher is the partnership; For each subscale: Average score Min = 1 and Max = 7
4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' attitudes
Time Frame: 2 months
Attitudes about Families Checklist (AFC); 16 items measured on a 7-point Likert scale. Three subscales "quieting/disquieting" (5 items), "partner-subordinate" (4 items) and "relevant-irrelevant" (7 items); Each one has a separate score; The higher the score, the more positive is the attitude; For each subscale: Average score Min = 1 and Max = 7
2 months
Change from baseline in partnership-based decision-making-formal caregivers' attitude
Time Frame: 4 months (follow-up)
Attitudes about Families Checklist (AFC); 16 items measured on a 7-point Likert scale. Three subscales "quieting/disquieting" (5 items), "partner-subordinate" (4 items) and "relevant-irrelevant" (7 items); Each one has a separate score; The higher the score, the more positive is the attitude; For each subscale: Average score Min = 1 and Max = 7
4 months (follow-up)
Change from baseline in empowerment-formal caregivers
Time Frame: 2 months
Unique question ("When the older person manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
2 months
Change from baseline in empowerment-formal caregivers
Time Frame: 4 months (follow-up)
Unique question ("When the older person manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
4 months (follow-up)
Change from baseline in empowerment-family caregivers
Time Frame: 2 months
Unique question ("When my relative manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
2 months
Change from baseline in empowerment-family caregivers
Time Frame: 4 months (follow-up)
Unique question ("When my relative manifests vocal behaviours, I feel I can do something for her/him"); 100-mm visual analogue scale ranging from Min = 0 (I feel that I cannot do anything for her/him) to Max = 100 (I feel I can always do something for her/him); The higher the score, the higher is the empowerment.
4 months (follow-up)
Cost
Time Frame: 2 months
Management data
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Anne Bourbonnais, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 30, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 17, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 17, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 24, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 156273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Behavioral Symptoms

Clinical Trials on Approach based on the meanings of vocal behaviours

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings