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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04517877
Other study ID # Pz-A106a
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date July 15, 2020
Est. completion date May 30, 2021

Study information

Verified date May 2023
Source Photozig, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 164
Est. completion date May 30, 2021
Est. primary completion date May 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Caring Response App
Participants will receive the Caring Light mobile app containing the coping skills training.
Traditional Educational/Resources Program
Participants will receive a traditional educational/resources program, containing a workbook and online resources.

Locations

Country Name City State
United States Photozig, Inc. Mountain View California

Sponsors (1)

Lead Sponsor Collaborator
Photozig, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Center for Epidemiological Studies Depression Scale 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
Primary 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. 3 months
Primary 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. 3 months
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