DementiaVALIDNCT01646723
Volunteers Adding Life in Dementia
A study testing Volunteers Adding Life in Dementia (VALID) Program in people with Dementia and Alzheimer Disease, run by Queen's University at 1 site in Canada.
Trial summary
The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Dementia, Alzheimer Disease, Behavior
- What is being tested?
- Volunteers Adding Life in Dementia (VALID) Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2012to 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
- in nursing home 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 risk
- 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: Volunteers Adding Life in Dementia (VALID)
The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.
- Conditions
- Dementia, Alzheimer Disease, Behavior
- Being tested
- Volunteers Adding Life in Dementia (VALID) Program
- Medical subject headings
- Dementia, Alzheimer Disease, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Volunteers Adding Life in Dementia (VALID) ProgramBehavioural
The VALID intervention will consist of 2 phases. First, volunteers will complete an assessment involving recording of a "Life Story" for each patient participant. This will include information on the patient's psychosocial history, occupational history, hobbies, interests and preferred activities using information from the LTC medical record and interviews with the patient and family members. Based on this information, a variety of potential psychosocial interventions will be developed for the individual with the assistance of the recreation therapist at the LTC. The second phase will involve implementation of the VALID intervention. Each individual with dementia will receive personalized pleasant activities for a minimum session of 30 minutes at a frequency of 3 times per week. One volunteer will complete the "Life Story" assessment and up to 3 volunteers may be involved with implementing the VALID program for each resident.
| Study group | Role | What they receive |
|---|---|---|
| VALID Intervention | Experimental | Volunteers Adding Life in Dementia (VALID) Program Receives: Behavioral: Volunteers Adding Life in Dementia (VALID) Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Cohen-Mansfield Agitation Inventory (CMAI) score
Measured: Baseline and 12 weeks
Secondary outcomes (9)
Clinically significant reduction in agitation
30% reduction in CMAI score
Measured: Baseline and 12 weeks
Remission of neuropsychiatric symptoms
CMAI score <40
Measured: Baseline and 12 weeks
Change in Neuropsychiatric Inventory (NPI) score
Measured: Baseline and 12 weeks
Change in depression symptoms (Cornell Depression in Dementia Rating Scale)
Measured: Baseline and 12 weeks
Dementia Quality of Life (DemQoL) Scale
Measured: Baseline and 12 weeks
Clinical Global Impression of Change (CGI-C)
Measured: Baseline and 12 weeks
Use and dose of required medication
Measured: Baseline and 12 weeks
Short form health survey
Volunteer quality of life
Measured: Baseline and 12 weeks
Change in Modified Nursing Care Assessment Scale score
Assessing nursing stress.
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJun 2012
- Primary completionDec 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- 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
- NCT01646723
- Sponsor's protocol ID
- VALID1
- Acronym
- VALID
- Status last verified
- Apr 2017
- First submitted
- 18 Jul 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
- Volunteers Adding Life in Dementia (VALID)
- ClinicalTrials.gov ID
- NCT01646723
- Acronym / sponsor ID
- VALID / VALID1
- Conditions
- Dementia, Alzheimer Disease, Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 20 Jul 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.
The objectives of our project are to: 1.) Develop a training program and manual for volunteers to implement evidence-based, non-pharmacological interventions for neuropsychiatric symptoms (NPS) of dementia in long-term care (LTC) settings; 2.) Recruit and train volunteers using the VALID program and pilot test the volunteer-led program with 20 individuals with Alzheimer's disease and NPS in a LTC facility in Kingston; and, 3.) Evaluate the effects of the VALID program on the symptoms of NPS, patient quality of life, volunteer's experience, and LTC staff stress.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| VALID Intervention | Experimental | Behavioral: Volunteers Adding Life in Dementia (VALID) ProgramVolunteers Adding Life in Dementia (VALID) Program |
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
- in nursing home 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 risk
- 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 |
|---|---|---|
| Volunteers Adding Life in Dementia (VALID) ProgramThe VALID intervention will consist of 2 phases. First, volunteers will complete an assessment involving recording of a "Life Story" for each patient participant. This will include information on the patient's psychosocial history, occupational history, hobbies, interests and preferred activities using information from the LTC medical record and interviews with the patient and family members. Based on this information, a variety of potential psychosocial interventions will be developed for the individual with the assistance of the recreation therapist at the LTC. The second phase will involve implementation of the VALID intervention. Each individual with dementia will receive personalized pleasant activities for a minimum session of 30 minutes at a frequency of 3 times per week. One volunteer will complete the "Life Story" assessment and up to 3 volunteers may be involved with implementing the VALID program for each resident. | Behavioural | VALID Intervention |
Primary outcome
Change in Cohen-Mansfield Agitation Inventory (CMAI) score
Time frame: Baseline and 12 weeks
9 secondary outcomes
Clinically significant reduction in agitation
Time frame: Baseline and 12 weeks
Remission of neuropsychiatric symptoms
Time frame: Baseline and 12 weeks
Change in Neuropsychiatric Inventory (NPI) score
Time frame: Baseline and 12 weeks
Change in depression symptoms (Cornell Depression in Dementia Rating Scale)
Time frame: Baseline and 12 weeks
Dementia Quality of Life (DemQoL) Scale
Time frame: Baseline and 12 weeks
Clinical Global Impression of Change (CGI-C)
Time frame: Baseline and 12 weeks
Use and dose of required medication
Time frame: Baseline and 12 weeks
Short form health survey
Time frame: Baseline and 12 weeks
Change in Modified Nursing Care Assessment Scale score
Time frame: Baseline and 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 Volunteers Adding Life in Dementia (VALID) Program in people with Dementia and Alzheimer 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 Cohen-Mansfield Agitation Inventory (CMAI) score (time frame: Baseline and 12 weeks). 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.