Volunteers Adding Life in Dementia

Alzheimer Disease Clinical Trial

— VALID  

Official title:

Volunteers Adding Life in Dementia (VALID)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01646723
• Other study ID #: VALID1
• Status: Completed
• Phase: N/A
• First received: July 18, 2012
• Last updated: April 13, 2017
• Start date: June 2012
• Est. completion date: March 2016

Study information

• Verified date: April 2017
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Alzheimer Disease
• Behavior
• Dementia

Intervention

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.

Locations

Country	Name	City	State
Canada	Extendicare Kingston	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Queen's University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Cohen-Mansfield Agitation Inventory (CMAI) score		Baseline and 12 weeks
Secondary	Clinically significant reduction in agitation	30% reduction in CMAI score	Baseline and 12 weeks
Secondary	Remission of neuropsychiatric symptoms	CMAI score <40	Baseline and 12 weeks
Secondary	Change in Neuropsychiatric Inventory (NPI) score		Baseline and 12 weeks
Secondary	Change in depression symptoms (Cornell Depression in Dementia Rating Scale)		Baseline and 12 weeks
Secondary	Dementia Quality of Life (DemQoL) Scale		Baseline and 12 weeks
Secondary	Clinical Global Impression of Change (CGI-C)		Baseline and 12 weeks
Secondary	Use and dose of required medication		Baseline and 12 weeks
Secondary	Short form health survey	Volunteer quality of life	Baseline and 12 weeks
Secondary	Change in Modified Nursing Care Assessment Scale score	Assessing nursing stress.	Baseline and 12 weeks