iCare Stress Management e-Training for Dementia Family Caregivers

This study has been completed.
Sponsor:
Collaborators:
Stanford University
Information provided by (Responsible Party):
Photozig, Inc.
ClinicalTrials.gov Identifier:
NCT01378195
First received: June 17, 2011
Last updated: February 22, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Alzheimer's Disease
Dementia
Behavioral: CBT-based program for dementia caregivers
Behavioral: Educational/Resources program
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: iCare Stress Management e-Training for Dementia Family Caregivers

Resource links provided by NLM:


Further study details as provided by Photozig, Inc.:

Primary Outcome Measures:
  • Perceived Stress Scale [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Revised Memory and Behavior Problems Checklist [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=4. Higher values represent a worse outcome.

  • Perceived Quality of Life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The "Perceived Quality of Life" (PQoL instrument) measures quality of life by the evaluation of major categories of fundamental life needs. This measure was developed using a normative sample of older individuals, and has been used in a number of studies investigating the effects of chronic disorders on the perceived quality of life. The scale contains items describing level of satisfaction with needs and resources in various categories. The scale refers to the caregiver. Minimum (worst value) = 0. Maximum score (best value=10. Higher values represent a better outcome.


Enrollment: 150
Study Start Date: May 2011
Study Completion Date: July 2012
Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT-based
CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
Behavioral: CBT-based program for dementia caregivers
Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.
Active Comparator: Educational/Resources Materials
Educational/Resources Materials: video, workbook, and website.
Behavioral: Educational/Resources program
Participants will receive a traditional educational/resources program, containing videos, workbook, and website.

Detailed Description:

The goal of this study is to develop the iCare Program, a DVD/online video training that builds skills and stimulates practice. We are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. We are designing the program to help to enhance caregivers' skills to deal with demanding tasks of caregiving, alleviate related stress, and improve quality of life.

Research Program Steps:

  1. Caregivers will be asked some simple questions about themselves and their family members to see if they are eligible for the project (fill out Enrollment Form and Informed Consent).
  2. A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.
  3. A DVD, materials, link to our website, login information, and instructions will be mailed to participants. We ask participants to watch the DVD, read printed materials, use the website, and follow instructions. Materials are expected to help participants in their caregiver role.
  4. After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.
  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01378195

Locations
United States, California
Photozig, Inc.
Moffett Field, California, United States, 94035-0128
Sponsors and Collaborators
Photozig, Inc.
Stanford University
Investigators
Principal Investigator: Bruno Kajiyama, MS Photozig, Inc.
  More Information

Additional Information:
No publications provided

Responsible Party: Photozig, Inc.
ClinicalTrials.gov Identifier: NCT01378195     History of Changes
Other Study ID Numbers: Pz-A103a, R44AG032762
Study First Received: June 17, 2011
Results First Received: August 30, 2012
Last Updated: February 22, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Photozig, Inc.:
Alzheimer's Disease
Dementia
caregiving
caregiver
coping
coping with caregiving
stress

Additional relevant MeSH terms:
Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders
Nervous System Diseases
Neurodegenerative Diseases
Tauopathies

ClinicalTrials.gov processed this record on October 22, 2014