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iCare Stress Management e-Training for Dementia Family Caregivers (iCare)

Primary Purpose

Alzheimer's Disease, Dementia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
CBT-based program for dementia caregivers
Educational/Resources program
Sponsored by
Photozig, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Photozig, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT-based

Educational/Resources Materials

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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. 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
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.

Full Information

First Posted
June 17, 2011
Last Updated
February 22, 2013
Sponsor
Photozig, Inc.
Collaborators
Stanford University, National Institute on Aging (NIA)
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1. Study Identification

Unique Protocol Identification Number
NCT01378195
Brief Title
iCare Stress Management e-Training for Dementia Family Caregivers
Acronym
iCare
Official Title
iCare Stress Management e-Training for Dementia Family Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
February 2013
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
July 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Photozig, Inc.
Collaborators
Stanford University, National Institute on Aging (NIA)

4. Oversight

5. Study Description

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.
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: 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). A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope. 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. After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-based
Arm Type
Experimental
Arm Description
CBT-based program (Cognitive Behavioral Therapy) with video, workbook, and website
Arm Title
Educational/Resources Materials
Arm Type
Active Comparator
Arm Description
Educational/Resources Materials: video, workbook, and website.
Intervention Type
Behavioral
Intervention Name(s)
CBT-based program for dementia caregivers
Intervention Description
Participants will receive a CBT-based program [Cognitive Behavioral Therapy], containing videos, workbook, and website.
Intervention Type
Behavioral
Intervention Name(s)
Educational/Resources program
Intervention Description
Participants will receive a traditional educational/resources program, containing videos, workbook, and website.
Primary Outcome Measure Information:
Title
Perceived Stress Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Revised Memory and Behavior Problems Checklist
Description
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.
Time Frame
3 months
Title
Perceived Quality of Life
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Kajiyama, MS
Organizational Affiliation
Photozig, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Photozig, Inc.
City
Moffett Field
State/Province
California
ZIP/Postal Code
94035-0128
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.icarefamily.com
Description
Dementia Caregiving Program

Learn more about this trial

iCare Stress Management e-Training for Dementia Family Caregivers

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