Volunteers Adding Life in Dementia: VALID (VALID)
Primary Purpose
Dementia, Alzheimer's Disease
Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Volunteer visits
Sponsored by
About this trial
This is an interventional health services research trial for Dementia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Queen's University
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Usual care
Volunteer visits
Arm Description
Individuals will receive usual care
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
Outcomes
Primary Outcome Measures
Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)
Secondary Outcome Measures
Change in Neuropsychiatric Inventory score
Change in Cornell Depression in Dementia Rating Scale score
Change in Dementia Quality of Life Scale (DEMQoL) score
Change in Clinical Global Impression of Change (CGI-C)score
Full Information
NCT ID
NCT01715181
First Posted
October 24, 2012
Last Updated
April 13, 2017
Sponsor
Queen's University
Collaborators
Alzheimer's Association
1. Study Identification
Unique Protocol Identification Number
NCT01715181
Brief Title
Volunteers Adding Life in Dementia: VALID
Acronym
VALID
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2015 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Alzheimer's Association
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dementia, Alzheimer's Disease
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Individuals will receive usual care
Arm Title
Volunteer visits
Arm Type
Experimental
Arm Description
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
Intervention Type
Other
Intervention Name(s)
Volunteer visits
Intervention Description
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
Primary Outcome Measure Information:
Title
Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)
Time Frame
Baseline, weeks 2,4,6,8 and 12
Secondary Outcome Measure Information:
Title
Change in Neuropsychiatric Inventory score
Time Frame
Baseline, weeks 4, 8, 12
Title
Change in Cornell Depression in Dementia Rating Scale score
Time Frame
Baseline, weeks 4, 8, 12
Title
Change in Dementia Quality of Life Scale (DEMQoL) score
Time Frame
Baseline, weeks 4, 8, 12
Title
Change in Clinical Global Impression of Change (CGI-C)score
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Modified nursing care assessment scale (M-NACS)
Time Frame
Baseline, week 12
Title
Short Form Health Survey
Description
Assessment of volunteer quality of life
Time Frame
Baseline, week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dallas P Seitz, MD
Organizational Affiliation
Queen's University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Queen's University
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L3N6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Volunteers Adding Life in Dementia: VALID
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