NCT01378195

Brief Summary

Photozig and Stanford University are creating a program to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. This home-based program includes a free DVD, printed materials, and resource website. In addition, after completing the program, participants will have free access to final online resources for 1 year. There are no face-to-face meetings, and participants can live anywhere in the United States.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started May 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 17, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

June 22, 2011

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6 months until next milestone

Results Posted

Study results publicly available

January 8, 2013

Completed
Last Updated

February 28, 2013

Status Verified

February 1, 2013

Enrollment Period

1.2 years

First QC Date

June 17, 2011

Results QC Date

August 30, 2012

Last Update Submit

February 22, 2013

Conditions

Keywords

Alzheimer's DiseaseDementiacaregivingcaregivercopingcoping with caregivingstress

Outcome Measures

Primary Outcomes (1)

  • Perceived Stress Scale

    The "Perceived Stress Scale" measures the overall level of stress. This instrument contains 10 items accessing overall appraisals of stress in the past month. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.

    3 months

Secondary Outcomes (2)

  • Revised Memory and Behavior Problems Checklist

    3 months

  • Perceived Quality of Life

    3 months

Study Arms (2)

CBT-based

EXPERIMENTAL

CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website

Behavioral: CBT-based program for dementia caregivers

Educational/Resources Materials

ACTIVE COMPARATOR

Educational/Resources Materials: video, workbook, and website.

Behavioral: Educational/Resources program

Interventions

Participants will receive a CBT-based program \[Cognitive Behavioral Therapy\], containing videos, workbook, and website.

CBT-based

Participants will receive a traditional educational/resources program, containing videos, workbook, and website.

Educational/Resources Materials

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Care for an individual with Alzheimer's Disease or other dementia.
  • Own a DVD player or have Internet access.
  • Minimum age of 21 years old.
  • Spend at least 8 hours/week caring for a person with dementia, which may include assisting, watching, monitoring, or being available to help (e.g. during sleep time).

You may not qualify if:

  • Severe psychological or physical illness.
  • Inability to read and follow English instructions.
  • High level of depressive symptoms.
  • Unwillingness to participate in all aspects of the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Photozig, Inc.

Moffett Field, California, 94035-0128, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Bruno Kajiyama
Organization
Photozig, Inc.

Study Officials

  • Bruno Kajiyama, MS

    Photozig, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2011

First Posted

June 22, 2011

Study Start

May 1, 2011

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

February 28, 2013

Results First Posted

January 8, 2013

Record last verified: 2013-02

Locations