Volunteers Adding Life in Dementia: VALID

This study is currently recruiting participants.
Verified August 2013 by Queen's University
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Dallas Seitz, Queen's University
ClinicalTrials.gov Identifier:
NCT01715181
First received: October 24, 2012
Last updated: August 13, 2013
Last verified: August 2013
  Purpose

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 Intervention
Dementia
Alzheimer's Disease
Other: Volunteer visits

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory) [ Time Frame: Baseline, weeks 2,4,6,8 and 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Neuropsychiatric Inventory score [ Time Frame: Baseline, weeks 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in Cornell Depression in Dementia Rating Scale score [ Time Frame: Baseline, weeks 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in Dementia Quality of Life Scale (DEMQoL) score [ Time Frame: Baseline, weeks 4, 8, 12 ] [ Designated as safety issue: No ]
  • Change in Clinical Global Impression of Change (CGI-C)score [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • Modified nursing care assessment scale (M-NACS) [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
  • Short Form Health Survey [ Time Frame: Baseline, week 12 ] [ Designated as safety issue: No ]
    Assessment of volunteer quality of life


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01715181

Contacts
Contact: Dallas P Seitz, MD 613-548-5567 ext 5942 seitzd@providencecare.ca

Locations
Canada, Ontario
Queen's University Recruiting
Kingston, Ontario, Canada, K7L3N6
Contact: Dallas P Seitz, MD    613-548-5567 ext 5942    seitzd@providencecare.ca   
Principal Investigator: Dallas P Seitz, MD         
Sponsors and Collaborators
Queen's University
Alzheimer's Association
Investigators
Principal Investigator: Dallas P Seitz, MD Queen's University
  More Information

No publications provided

Responsible Party: Dallas Seitz, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT01715181     History of Changes
Other Study ID Numbers: VALIDII, NIRG-12-236827
Study First Received: October 24, 2012
Last Updated: August 13, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 17, 2014