Alzheimer DiseasePhase 2NCT04517877

Caring Light Project for Family Caregivers

A Phase 2 study testing Caring Response App and Traditional Educational/Resources Program in people with Alzheimer Disease, run by Photozig, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Alzheimer Disease
What is being tested?: Caring Response App and Traditional Educational/Resources Program
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 164 participants
Where: 1 siteUnited States
Study dates: 15 Jul 2020to 30 May 2021
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

United States1 site

Photozig, Inc.
Mountain View, California, 94035-0128

Other trials in United States

About this study

Official title: 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.

Read the 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.

Conditions: Alzheimer Disease
Being tested: Caring Response App, Traditional Educational/Resources Program
Medical subject headings: Alzheimer Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

Study groups in NCT04517877
Study group	Role	What they receive
Caring Light Training	Experimental	Caring Light mobile app with coping skills training. Receives: Behavioral: Caring Response App
Educational Training	Active comparator	Traditional educational program. Receives: Behavioral: Traditional Educational/Resources Program

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 3 months
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.
Measured: 3 months
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.
Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jul 202030 May 2021

First posted18 Aug 2020
Study start15 Jul 2020
Primary completion30 May 2021
Study completion30 May 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Alzheimer DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 164 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04517877
Sponsor's protocol ID: Pz-A106a
Status last verified: May 2023
First submitted: 14 Aug 2020
Last updated: 18 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Alzheimer Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Caring Light Project for Caregivers of Individuals With Alzheimer's Disease
ClinicalTrials.gov ID: NCT04517877
Acronym / sponsor ID: Pz-A106a
Conditions: Alzheimer Disease
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 164 participants (actual)
Lead sponsor: Photozig, Inc.Industry (pharma, biotech, devices)
Study start: 15 Jul 2020 (actual)
Primary completion: 30 May 2021 (actual)
Study completion: 30 May 2021 (actual)
First posted: 18 Aug 2020 (actual)
Results: Posted 18 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Detailed description

Study design

Primary purpose: Supportive care
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Caring Light Training	Experimental	Behavioral: Caring Response AppCaring Light mobile app with coping skills training.
Educational Training	Active comparator	Behavioral: Traditional Educational/Resources ProgramTraditional educational program.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (4 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Caring Response AppParticipants will receive the Caring Light mobile app containing the coping skills training.	Behavioural	Caring Light Training
Traditional Educational/Resources ProgramParticipants will receive a traditional educational/resources program, containing a workbook and online resources.	Behavioural	Educational Training

Primary outcome

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.
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.
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.

Results and safety

Results posted to the registry on 18 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Caring Light Training	82	63
Educational Training	82	58

Primary outcome: Center for Epidemiological Studies Depression Scale

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Caring Light Training n = 63	Educational Training n = 58
Value	17.72 (10.90)	21.70 (9.93)

Population analysed: Caregivers with full data for the CES-D instrument were included in the outcomes analysis.

Primary outcome: Revised Memory and Behavior Problems Checklist

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Caring Light Training n = 62	Educational Training n = 53
Value	0.52 (0.54)	0.64 (0.55)

Population analysed: Caregivers with full data for the "Revised Memory and Behavior Problems Checklist" were included in the outcomes analysis.

Primary outcome: Perceived Stress Scale

Time frame: 3 months. Mean (Standard Deviation). Unit: units on a scale

Measure	Caring Light Training n = 62	Educational Training n = 57
Value	17.16 (7.41)	19.36 (5.82)

Population analysed: Caregivers with full data for the "Perceived Stress Scale" were included in the outcomes analysis.

Adverse events

Time frame: 3 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Caring Light Training	0 of 82 (0%)	0 of 82 (0%)	0 of 82
Educational Training	0 of 82 (0%)	0 of 82 (0%)	0 of 82

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Enrolling by invitationPhase 2
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruno Kajiyama, MS principal investigator

Photozig, Inc.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Caring Response App and Traditional Educational/Resources Program in people with Alzheimer Disease, run by Photozig, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Center for Epidemiological Studies Depression Scale (time frame: 3 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04517877.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2023.