DementiaVALIDNCT01715181
Volunteers Adding Life in Dementia: VALID
A study testing Volunteer visits in people with Dementia and Alzheimer's Disease, run by Queen's University at 1 site in Canada.
Trial summary
Older adults with Alzheimer's disease and other forms of dementia frequently develop challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological strategies to manage these symptoms such as music, exercise, and participating in pleasant social events have been demonstrated to be safe… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer's Disease
- What is being tested?
- Volunteer visits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Mar 2016
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- diagnosis of Alzheimer's disease or related forms of dementia
- significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of >39
- resident in LTC facility for at least 30 days
- presence of a caregiver or substitute decision maker willing to consent to treatment
- no changes in psychotropic medications in the 2 weeks preceding enrolment in study
Who cannot join
- depressive symptoms presenting acute risk (i.e. suicidal ideation)
- physically aggressive behavior posing safety risk to others
- uncontrolled pain
- currently receiving palliative care
- medically unstable with life expectancy of < 6 months
- currently awaiting transfer to another LTC facility or hospital
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Cluster-Randomized Controlled Trial Evaluating the Effects of a Volunteer-Led Nonpharmacological Intervention to Reduce Neuropsychiatric Symptoms of Dementia in Long-Term Care Residents
Older adults with Alzheimer's disease and other forms of dementia frequently develop challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological strategies to manage these symptoms such as music, exercise, and participating in pleasant social events have been demonstrated to be safe and effective strategies to reduce these behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and implement a volunteer-led program to reduce behavioral symptoms and improve the quality of life of older adults with dementia who are residing in long-term care facilities.
Read the detailed description
The number of older adults with Alzheimer's disease (AD) and related forms of dementia is increasing in Canada and the majority of individuals with dementia develop neuropsychiatric symptoms (NPS) such as agitation, psychosis, depression and anxiety at some time during their illness. NPS are particularly problematic in long-term care (LTC) where approximately 60% of individuals have dementia, and 80% of individuals with dementia have NPS at any time. Adverse outcomes associated with NPS include increased use of psychotropic medications, stress for families and nursing staff, increased costs of care, and decreased quality of life. A novel approach to implementing non-pharmacological interventions for LTC residents with NPS is the use of volunteers. Volunteer-led programs have been demonstrated to be an effective, inexpensive, and sustainable method of implementing psychosocial interventions for older adults in acute care. The objectives of our project are to: 1.) Recruit and train approximately 40 volunteers in the VALID program; 2.) Conduct a cluster-randomized controlled trial of the VALID program in 6 LTC facilities (3 intervention and 3 control LTC sites; 60 individuals with dementia in each of the experimental and control arms) to determine the effect of the VALID program on symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress, 3.) Determine key components of the VALID program that served as facilitators and barriers to implementation.
- Conditions
- Dementia, Alzheimer's Disease
- Being tested
- Volunteer visits
- Medical subject headings
- Dementia, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteer visitsOther
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
| Study group | Role | What they receive |
|---|---|---|
| Usual care | No intervention | Individuals will receive usual care |
| Volunteer visits | Experimental | Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study. Receives: Other: Volunteer visits |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)
Measured: Baseline, weeks 2,4,6,8 and 12
Secondary outcomes (4)
Change in Neuropsychiatric Inventory score
Measured: Baseline, weeks 4, 8, 12
Change in Cornell Depression in Dementia Rating Scale score
Measured: Baseline, weeks 4, 8, 12
Change in Dementia Quality of Life Scale (DEMQoL) score
Measured: Baseline, weeks 4, 8, 12
Change in Clinical Global Impression of Change (CGI-C)score
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2015
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DementiaStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Dr. Dallas Seitz, Queen's University
- Investigators
- Dallas P Seitz, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01715181
- Sponsor's protocol ID
- VALIDII
- Other IDs
- NIRG-12-236827
- Acronym
- VALID
- Status last verified
- Apr 2017
- First submitted
- 24 Oct 2012
- Last updated
- 14 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cluster-Randomized Controlled Trial Evaluating the Effects of a Volunteer-Led Nonpharmacological Intervention to Reduce Neuropsychiatric Symptoms of Dementia in Long-Term Care Residents
- ClinicalTrials.gov ID
- NCT01715181
- Acronym / sponsor ID
- VALID / VALIDII
- Conditions
- Dementia, Alzheimer's Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- Jan 2013
- Primary completion
- Jun 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 26 Oct 2012 (estimated)
- 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.
Older adults with Alzheimer's disease and other forms of dementia frequently develop challenging neuropsychiatric symptoms (NPS) as a result of their illness. Non-pharmacological strategies to manage these symptoms such as music, exercise, and participating in pleasant social events have been demonstrated to be safe and effective strategies to reduce these behavioral symptoms. Our project, Volunteers Adding Life in Dementia (VALID), will design and implement a volunteer-led program to reduce behavioral symptoms and improve the quality of life of older adults with dementia who are residing in long-term care facilities.
Detailed description
The number of older adults with Alzheimer's disease (AD) and related forms of dementia is increasing in Canada and the majority of individuals with dementia develop neuropsychiatric symptoms (NPS) such as agitation, psychosis, depression and anxiety at some time during their illness. NPS are particularly problematic in long-term care (LTC) where approximately 60% of individuals have dementia, and 80% of individuals with dementia have NPS at any time. Adverse outcomes associated with NPS include increased use of psychotropic medications, stress for families and nursing staff, increased costs of care, and decreased quality of life. A novel approach to implementing non-pharmacological interventions for LTC residents with NPS is the use of volunteers. Volunteer-led programs have been demonstrated to be an effective, inexpensive, and sustainable method of implementing psychosocial interventions for older adults in acute care. The objectives of our project are to: 1.) Recruit and train approximately 40 volunteers in the VALID program; 2.) Conduct a cluster-randomized controlled trial of the VALID program in 6 LTC facilities (3 intervention and 3 control LTC sites; 60 individuals with dementia in each of the experimental and control arms) to determine the effect of the VALID program on symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress, 3.) Determine key components of the VALID program that served as facilitators and barriers to implementation.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | No intervention | –Individuals will receive usual care |
| Volunteer visits | Experimental | Other: Volunteer visitsVolunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- diagnosis of Alzheimer's disease or related forms of dementia
- significant symptoms of agitation as measured by a Cohen-Mansfield Agitation Inventory (CMAI) total score of >39
- resident in LTC facility for at least 30 days
- presence of a caregiver or substitute decision maker willing to consent to treatment
- no changes in psychotropic medications in the 2 weeks preceding enrolment in study
Key exclusion criteria (6 listed)
- depressive symptoms presenting acute risk (i.e. suicidal ideation)
- physically aggressive behavior posing safety risk to others
- uncontrolled pain
- currently receiving palliative care
- medically unstable with life expectancy of < 6 months
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 |
|---|---|---|
| Volunteer visitsVolunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study. | Other | Volunteer visits |
Primary outcome
Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)
Time frame: Baseline, weeks 2,4,6,8 and 12
4 secondary outcomes
Change in Neuropsychiatric Inventory score
Time frame: Baseline, weeks 4, 8, 12
Change in Cornell Depression in Dementia Rating Scale score
Time frame: Baseline, weeks 4, 8, 12
Change in Dementia Quality of Life Scale (DEMQoL) score
Time frame: Baseline, weeks 4, 8, 12
Change in Clinical Global Impression of Change (CGI-C)score
Time frame: 12 weeks
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 14 Apr 2017.
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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.
Dallas P Seitz, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Volunteer visits in people with Dementia and Alzheimer's Disease, run by Queen's University at 1 site 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 5 inclusion and 6 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 14 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory) (time frame: Baseline, weeks 2,4,6,8 and 12). 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 14 Apr 2017.