Behavioral SymptomsNCT03506672
Assessing the Effectiveness of an Approach for Vocal Behaviors in Older People Living in Nursing Homes
A study testing Approach based on the meanings of vocal behaviours and Usual practices in people with Behavioral Symptoms, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 7 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Behavioral Symptoms
- What is being tested?
- Approach based on the meanings of vocal behaviours and Usual practices
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 157 participants
- Where
- 7 sitesCanada
- Study dates
- 30 Nov 2018to 17 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Canada7 sites
CHSLD Laval et Riviera
Laval, Quebec, H3C 3J7
CIUSSS Nord-de-l'Île-de-Montréal
Montreal, Quebec, H2V 4T4
Residence Angelica
Montreal, Quebec, H2V 4T4
CIUSSS Ouest-de-l'Île-de-Montréal
Montreal, Quebec, H3C 3J7
Résidence Berthiaume-du-Tremblay
Montreal, Quebec, H3C 3J7
Vigi Santé
Montreal, Quebec, H3C 3J7
CIUSSS Centre-Sud-de-l'Île-de-Montréal
Montreal, Quebec
About this study
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
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.
Read the 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.
- Conditions
- Behavioral Symptoms
- Being tested
- Approach based on the meanings of vocal behaviours, Usual practices
- Keywords
- Behavioral and psychological symptoms of dementia, Psychosocial interventions, Well-being, Long-term care facilities, Family and formal caregivers, Partnership
- Medical subject headings
- Behavioral Symptoms, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Approach based on the meanings of vocal behavioursOther
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.
Usual practicesOther
Usual practices of formal caregivers regarding vocal behaviours
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Approach based on the meanings of vocal behaviours Receives: Other: Approach based on the meanings of vocal behaviours |
| Control group | Active comparator | Usual practices of formal caregivers regarding vocal behaviours Receives: Other: Usual practices |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 months
Secondary outcomes (20)
Change from baseline frequency of vocal behaviors to 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
Measured: 4 months (follow-up)
Change from baseline in well-being
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
Measured: 2 months
Change from baseline in well-being
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
Measured: 4 months (follow-up)
Change from baseline in medication use
Medical chart
Measured: 2 months
Change from baseline in medication use
Medical chart
Measured: 4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
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
Measured: 2 months
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
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
Measured: 4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
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
Measured: 2 months
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
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
Measured: 4 months (follow-up)
Change from baseline in partnership-based decision-making-family caregivers' perspective
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
Measured: 2 months
Change from baseline in partnership-based decision-making-family caregivers' perspective
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
Measured: 4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' perspective
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
Measured: 2 months
Change from baseline in partnership-based decision-making-formal caregivers' perspective
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
Measured: 4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' attitudes
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
Measured: 2 months
Change from baseline in partnership-based decision-making-formal caregivers' attitude
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
Measured: 4 months (follow-up)
Change from baseline in empowerment-formal caregivers
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.
Measured: 2 months
Change from baseline in empowerment-formal caregivers
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.
Measured: 4 months (follow-up)
Change from baseline in empowerment-family caregivers
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.
Measured: 2 months
Change from baseline in empowerment-family caregivers
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.
Measured: 4 months (follow-up)
Cost
Management data
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2018
- Study start30 Nov 2018
- Primary completion17 Apr 2025
- Study completion17 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Behavioral SymptomsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 157 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Bourbonnais, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
- Investigators
- Anne Bourbonnais, Principal investigator, Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03506672
- Sponsor's protocol ID
- 156273
- Status last verified
- Apr 2025
- First submitted
- 9 Apr 2018
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03506672
- Acronym / sponsor ID
- 156273
- Conditions
- Behavioral Symptoms
- Keywords
- Behavioral and psychological symptoms of dementia, Psychosocial interventions, Well-being, Long-term care facilities, Family and formal caregivers, Partnership
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 157 participants (actual)
- Lead sponsor
- Centre de Recherche de l'Institut Universitaire de Geriatrie de MontrealUniversity, hospital or other
- Study start
- 30 Nov 2018 (actual)
- Primary completion
- 17 Apr 2025 (actual)
- Study completion
- 17 Apr 2025 (actual)
- First posted
- 24 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Other: Approach based on the meanings of vocal behavioursApproach based on the meanings of vocal behaviours |
| Control group | Active comparator | Other: Usual practicesUsual practices of formal caregivers regarding vocal behaviours |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Approach based on the meanings of vocal behavioursSystematic 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. | Other | Experimental group |
| Usual practicesUsual practices of formal caregivers regarding vocal behaviours | Other | Control group |
Primary outcome
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
20 secondary outcomes
Change from baseline frequency of vocal behaviors to follow-up
Time frame: 4 months (follow-up)
Change from baseline in well-being
Time frame: 2 months
Change from baseline in well-being
Time frame: 4 months (follow-up)
Change from baseline in medication use
Time frame: 2 months
Change from baseline in medication use
Time frame: 4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
Time frame: 2 months
Change from baseline in perceived disruptiveness of vocal behaviors-formal caregivers
Time frame: 4 months (follow-up)
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
Time frame: 2 months
Change from baseline in perceived disruptiveness of vocal behaviors-family caregivers
Time frame: 4 months (follow-up)
Change from baseline in partnership-based decision-making-family caregivers' perspective
Time frame: 2 months
Change from baseline in partnership-based decision-making-family caregivers' perspective
Time frame: 4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' perspective
Time frame: 2 months
Change from baseline in partnership-based decision-making-formal caregivers' perspective
Time frame: 4 months (follow-up)
Change from baseline in partnership-based decision-making-formal caregivers' attitudes
Time frame: 2 months
Change from baseline in partnership-based decision-making-formal caregivers' attitude
Time frame: 4 months (follow-up)
Change from baseline in empowerment-formal caregivers
Time frame: 2 months
Change from baseline in empowerment-formal caregivers
Time frame: 4 months (follow-up)
Change from baseline in empowerment-family caregivers
Time frame: 2 months
Change from baseline in empowerment-family caregivers
Time frame: 4 months (follow-up)
Cost
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2025.
- Research website of principal investigatorLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne Bourbonnais principal investigator
Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Approach based on the meanings of vocal behaviours and Usual practices in people with Behavioral Symptoms, run by Centre de Recherche de l'Institut Universitaire de Geriatrie de Montreal at 7 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline frequency of vocal behaviors (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2025.