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Completed

NCT Number: NCT01646723

Volunteers Adding Life in Dementia

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.

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Key information

Conditions

Dementia Alzheimer Disease Behavior Brain Diseases Central Nervous System Diseases Mental Disorders Nervous System Diseases Neurocognitive Disorders Neurodegenerative Diseases Tauopathies

Age range

65 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Extendicare Kingston

Kingston, Ontario, K7M6P4, Canada

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
  • 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.

Treatment and study plan

Volunteers Adding Life in Dementia (VALID) Program

Behavioral

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 outcomes

  1. Change in Cohen-Mansfield Agitation Inventory (CMAI) score

    Time frame: Baseline and 12 weeks

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Registry information

Official study title

Volunteers Adding Life in Dementia (VALID)

Acronym: VALID

Important dates

Study start
2012
Primary completion
2015
Study completion
2016
First posted
Jul 20, 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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