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OpenTrials
Completed

NCT Number: NCT01715181

Volunteers Adding Life in Dementia: VALID

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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University

Kingston, Ontario, K7L3N6, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Volunteer visits

Other

Volunteers will visit 3 times per week with a visit duration of 30 minutes for each visit during the study.

Primary outcomes

  1. Change in neuropsychiatric symptoms (measured by the Cohen-Mansfield Agitation Inventory)

    Time frame: Baseline, weeks 2,4,6,8 and 12

Secondary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Alzheimer's Association

Registry information

Official study 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

Acronym: VALID

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Oct 26, 2012
Registry last updated
Apr 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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