iCare Stress Management e-Training for Dementia Family Caregivers

NCT ID: NCT01378195

Last Updated: 2013-02-28

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-05-31

Study Completion Date

2012-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Alzheimer's Disease Dementia

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Alzheimer's Disease Dementia caregiving caregiver coping coping with caregiving stress

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT-based

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

Group Type EXPERIMENTAL

CBT-based program for dementia caregivers

Intervention Type BEHAVIORAL

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

Educational/Resources Materials

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

Group Type ACTIVE_COMPARATOR

Educational/Resources program

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT-based program for dementia caregivers

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

Intervention Type BEHAVIORAL

Educational/Resources program

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

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Stanford University

OTHER

Sponsor Role collaborator

National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Photozig, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Bruno Kajiyama, MS

Role: PRINCIPAL_INVESTIGATOR

Photozig, Inc.

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Photozig, Inc.

Moffett Field, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Related Links

Access external resources that provide additional context or updates about the study.

http://www.icarefamily.com

Dementia Caregiving Program

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R44AG032762

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pz-A103a

Identifier Type: -

Identifier Source: org_study_id