- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04517877
Caring Light Project for Family Caregivers
May 16, 2023 updated by: Photozig, Inc.
Caring Light Project for Caregivers of Individuals With Alzheimer's Disease
Caring Light is designed to help caregivers of someone with Alzheimer's Disease and related dementia to cope with the difficulties related to caregiving, reduce stress, and improve quality of life.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The goals of this study are to evaluate materials related to dementia caregiving and how to cope with difficult situations faced by caregivers.
Based on this research, the investigators are developing the new Caring Light mobile app with a self-paced program to enhance the quality of life, a curriculum that incorporates relaxation techniques, and coping skills training.
Study Type
Interventional
Enrollment (Actual)
164
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Mountain View, California, United States, 94035-0128
- Photozig, Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Care for an individual with Alzheimer's Disease or other dementia.
- Own a smartphone or tablet and have Internet access.
- Minimum age of 18 years old.
- Spend at least 8 hours/week caring for a person with dementia.
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Educational Training
Traditional educational program.
|
Participants will receive a traditional educational/resources program, containing a workbook and online resources.
|
Experimental: Caring Light Training
Caring Light mobile app with coping skills training.
|
Participants will receive the Caring Light mobile app containing the coping skills training.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceived Stress Scale
Time Frame: 3 months
|
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
|
Revised Memory and Behavior Problems Checklist
Time Frame: 3 months
|
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.
|
3 months
|
Center for Epidemiological Studies Depression Scale
Time Frame: 3 months
|
The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.
The scale refers to the caregiver.
Minimum score (best value)=0.
Maximum score (worst value)=60.
Higher values represent a worse outcome.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Bruno Kajiyama, MS, Photozig, Inc.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 15, 2020
Primary Completion (Actual)
May 30, 2021
Study Completion (Actual)
May 30, 2021
Study Registration Dates
First Submitted
August 14, 2020
First Submitted That Met QC Criteria
August 14, 2020
First Posted (Actual)
August 18, 2020
Study Record Updates
Last Update Posted (Actual)
May 18, 2023
Last Update Submitted That Met QC Criteria
May 16, 2023
Last Verified
May 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pz-A106a
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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