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Volunteers Adding Life in Dementia: VALID (VALID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01715181
Recruitment Status : Completed
First Posted : October 26, 2012
Last Update Posted : April 14, 2017
Alzheimer's Association
Information provided by (Responsible Party):
Dr. Dallas Seitz, Queen's University

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer's Disease Other: Volunteer visits Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
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 Start Date : January 2013
Actual Primary Completion Date : June 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
No Intervention: Usual care
Individuals will receive usual care
Experimental: Volunteer visits
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.
Other: Volunteer visits
Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.

Primary Outcome Measures :
  1. Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory) [ Time Frame: Baseline, weeks 2,4,6,8 and 12 ]

Secondary Outcome Measures :
  1. Change in Neuropsychiatric Inventory score [ Time Frame: Baseline, weeks 4, 8, 12 ]
  2. Change in Cornell Depression in Dementia Rating Scale score [ Time Frame: Baseline, weeks 4, 8, 12 ]
  3. Change in Dementia Quality of Life Scale (DEMQoL) score [ Time Frame: Baseline, weeks 4, 8, 12 ]
  4. Change in Clinical Global Impression of Change (CGI-C)score [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Modified nursing care assessment scale (M-NACS) [ Time Frame: Baseline, week 12 ]
  2. Short Form Health Survey [ Time Frame: Baseline, week 12 ]
    Assessment of volunteer quality of life

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01715181

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Canada, Ontario
Queen's University
Kingston, Ontario, Canada, K7L3N6
Sponsors and Collaborators
Queen's University
Alzheimer's Association
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Principal Investigator: Dallas P Seitz, MD Queen's University

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Responsible Party: Dr. Dallas Seitz, Assistant Professor, Queen's University Identifier: NCT01715181     History of Changes
Other Study ID Numbers: VALIDII
NIRG-12-236827 ( Other Grant/Funding Number: Alzheimer's Association )
First Posted: October 26, 2012    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
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Alzheimer Disease
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders