LifeZig Personalized Reminiscence Video With Slideshows and Music for Individuals With Alzheimer's and Dementia

Dementia Clinical Trial

— Lifezig  

Official title:

LifeZig System for Individuals With Alzheimer's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759863
• Other study ID #: Pz-A102b
• Secondary ID: R44AG022261
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: February 22, 2010
• Start date: August 2006
• Est. completion date: April 2009

Study information

• Verified date: February 2010
• Source: Photozig, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The LifeZig Project is a research study of a new reminiscence activity for individuals with Alzheimer's Disease (AD) and other types of dementia, based on the LifeZig system, with personalized video channels containing old photographs and music on television.

The goal of the LifeZig study is to enhance the quality of life for dementia patients and their families/caregivers, decrease the burden of care, and contribute to positive interaction between dementia patients and families/caregivers.

Description:

This program creates personalized TV channels with old photographs of AD patients, music, narration and relaxing sounds; as an activity to relax dementia patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. completion date: April 2009
• Est. primary completion date: April 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria:

• Inclusion criteria for dementia patients:

• documented diagnosis of probable Alzheimer's or other type of dementia, medically stable, and visual/hearing capabilities to watch television.

• Inclusion criteria for family members/caregivers:

• provide care or be a family member of dementia patient, have knowledge of the person, and be able to provide old photographs of dementia patient.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Alzheimer Disease
• Alzheimer's Disease
• Dementia

Intervention

Behavioral:
• Lifezig
Personalized Reminiscence Video

Locations

Country	Name	City	State
United States	Photozig, Inc.	Moffett Field	California

Sponsors (1)

Lead Sponsor	Collaborator
Photozig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Multidimensional Observation Scale for Elderly Subject	This scale reflects the overall well-being of dementia patients. The construct being assessed is the quality of life of dementia patients, related to patient functioning, disoriented behavior, depression/anxiety, irritable behavior, and withdrawn behavior, consisting of 32 items, divided in four sub-scales: "Personal Care", "Communication, Awareness & Memory", "Mood", and "Interpersonal Awareness Behaviors". The overall score provides an indication of the overall perceived well-being of the dementia patient. Best value = 32. Worst Value = 144.	6 months	No
Secondary	Revised Memory and Behavior Problems Checklist	This scale measures the type/number of dementia patients disturbing behaviors, and how much they bother caregivers with 24 items describing possible troublesome behaviors that the patient might evidence in the past month. Caregivers are first asked whether the dementia patient had displayed any of these in the time period, and secondly to rate on a 5-point scale (0=not at all; 4= extremely) how much this "bothered or upset" them. A "conditional bother" score is calculated which is the "upset" or "bother" ratings for only the problematic behavior that occurred. Best value = 0. Worst Value = 96.	6 months	No
Secondary	Center for Epidemiologic Studies Depression Scale	The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week. The construct being assessed is the caregiver depression. Best value = 0. Worst Value = 60.	6 months	No