iCare Stress Management e-Training for Dementia Family Caregivers
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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 |
- 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.
- 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:
- 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.
Eligibility| Ages Eligible for Study: | 21 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| United States, California | |
| Photozig, Inc. | |
| Moffett Field, California, United States, 94035-0128 | |
| 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 Nervous System Diseases |
Tauopathies Neurodegenerative Diseases Delirium, Dementia, Amnestic, Cognitive Disorders Mental Disorders |
ClinicalTrials.gov processed this record on June 18, 2013