Volunteers Adding Life in Dementia (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: NCT01646723
Recruitment Status : Completed
First Posted : July 20, 2012
Last Update Posted : April 14, 2017
Information provided by (Responsible Party):
Dr. Dallas Seitz, Queen's University

Brief 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 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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Behavior Behavioral: Volunteers Adding Life in Dementia (VALID) Program Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 75 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Volunteers Adding Life in Dementia (VALID)
Study Start Date : June 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dementia

Arm Intervention/treatment
Experimental: VALID Intervention
Volunteers Adding Life in Dementia (VALID) Program
Behavioral: Volunteers Adding Life in Dementia (VALID) Program
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.

Primary Outcome Measures :
  1. Change in Cohen-Mansfield Agitation Inventory (CMAI) score [ Time Frame: Baseline and 12 weeks ]

Secondary Outcome Measures :
  1. Clinically significant reduction in agitation [ Time Frame: Baseline and 12 weeks ]
    30% reduction in CMAI score

  2. Remission of neuropsychiatric symptoms [ Time Frame: Baseline and 12 weeks ]
    CMAI score <40

  3. Change in Neuropsychiatric Inventory (NPI) score [ Time Frame: Baseline and 12 weeks ]
  4. Change in depression symptoms (Cornell Depression in Dementia Rating Scale) [ Time Frame: Baseline and 12 weeks ]
  5. Dementia Quality of Life (DemQoL) Scale [ Time Frame: Baseline and 12 weeks ]
  6. Clinical Global Impression of Change (CGI-C) [ Time Frame: Baseline and 12 weeks ]
  7. Use and dose of required medication [ Time Frame: Baseline and 12 weeks ]
  8. Short form health survey [ Time Frame: Baseline and 12 weeks ]
    Volunteer quality of life

  9. Change in Modified Nursing Care Assessment Scale score [ Time Frame: Baseline and 12 weeks ]
    Assessing nursing stress.

Information from the National Library of Medicine

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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
  • 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

Exclusion Criteria:

  • 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.

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): NCT01646723

Canada, Ontario
Extendicare Kingston
Kingston, Ontario, Canada, K7M6P4
Sponsors and Collaborators
Queen's University
Principal Investigator: Dallas P Seitz, MD Queen's University

Responsible Party: Dr. Dallas Seitz, MD, Queen's University Identifier: NCT01646723     History of Changes
Other Study ID Numbers: VALID1
First Posted: July 20, 2012    Key Record Dates
Last Update Posted: April 14, 2017
Last Verified: April 2017

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