Volunteers Adding Life in Dementia: VALID

NCT01715181 | Completed

• 2 other identifiers: VALIDIINIRG-12-236827
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer's Disease

Outcome Measures

Primary Outcomes (1)

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

  Baseline, weeks 2,4,6,8 and 12

Secondary Outcomes (4)

• Change in Neuropsychiatric Inventory score

  Baseline, weeks 4, 8, 12

• Change in Cornell Depression in Dementia Rating Scale score

  Baseline, weeks 4, 8, 12

• Change in Dementia Quality of Life Scale (DEMQoL) score

  Baseline, weeks 4, 8, 12

• Change in Clinical Global Impression of Change (CGI-C)score

  12 weeks

Other Outcomes (2)

• Modified nursing care assessment scale (M-NACS)

  Baseline, week 12

• Short Form Health Survey

  Baseline, week 12

Study Arms (2)

Usual care

NO INTERVENTION

Individuals will receive usual care

Volunteer visits

EXPERIMENTAL

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

Other: Volunteer visits

Interventions

Volunteer visits OTHER

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

Volunteer visits

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Queen's University: lead
• Alzheimer's Association: collaborator

Study Sites (1)

Queen's University

Kingston, Ontario, K7L3N6, Canada

Location

MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Study Officials

• Dallas P Seitz, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 24, 2012
• First Posted: October 26, 2012
• Study Start: January 1, 2013
• Primary Completion: June 1, 2015
• Study Completion: March 1, 2016
• Last Updated: April 14, 2017

Record last verified: 2017-04

Locations

CA (1)