Volunteers Adding Life in Dementia

NCT ID: NCT01646723

Last Updated: 2017-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-30
• Study Completion Date: 2016-03-31

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.

Conditions

Dementia; Alzheimer Disease; Behavior

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

VALID Intervention

Volunteers Adding Life in Dementia (VALID) Program

Group Type: EXPERIMENTAL

Volunteers Adding Life in Dementia (VALID) Program

Intervention Type: 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.

Interventions

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.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Queen's University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Dallas Seitz

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dallas P Seitz, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Extendicare Kingston

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

VALID1

Identifier Type: -

Identifier Source: org_study_id