Alzheimer's DiseaseNCT02489110
Webnovela for Hispanic Dementia Family Caregivers
A study testing Webnovela and Information in people with Alzheimer's Disease and Dementia, run by Photozig, Inc. at 1 site in United States.
Trial summary
Photozig and Stanford University are creating a new program for Hispanic dementia caregivers to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alzheimer's Disease, Dementia
- What is being tested?
- Webnovela and Information
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2015to Sep 2016
- Phase
- Interventional
- 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.
- Have Internet access or own a DVD player.
- Minimum age of 18 years old.
- Belong to Hispanic/Latino ethnic group.
- 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)
Who cannot join
- Severe psychological or physical illness.
- Inability to read and follow Spanish 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.
Moffett Field, California, 94035-0128
About this study
Photozig and Stanford University are creating a new program for Hispanic dementia caregivers to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. The program includes a new education online telenovela (Webnovela), online resources, handouts and a DVD (for users without Internet) on how to deal with caregiving stress and handle difficult situations.
Read the detailed description
The goal of Webnovela program is to evaluate and develop materials for helping caregivers to cope with caregiving, alleviate related distress, and improve their quality of life.
The investigators are evaluating different materials, which may provide caregiving strategies, practical tips and 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.
- Participants will receive links to online resources, related materials and instructions. The investigators ask participants to access the online resources, read provided brochures and guides, and follow the 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.
- Conditions
- Alzheimer's Disease, Dementia
- Being tested
- Webnovela, Information
- Keywords
- Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress, Hispanic caregiver, Latino caregiver
- Medical subject headings
- Alzheimer Disease, Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WebnovelaBehavioural
InformationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Webnovela | Experimental | Caregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access. Receives: Behavioral: Webnovela |
| Control | Active comparator | Caregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language. Receives: Behavioral: Information |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stress on the 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. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
Measured: 3 months
Secondary outcomes (1)
Caregiver Burden on the 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2015 (estimated)
- Study startJun 2015
- Primary completionMay 2016
- Study completionSep 2016
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's 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Photozig, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Stanford University
- Responsible party
- Principal investigator, Bruno Kajiyama, Photozig, Inc.
- Investigators
- Bruno Kajiyama, MS, Principal investigator, Photozig, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02489110
- Sponsor's protocol ID
- Pz-A104a
- Other IDs
- R44AG041552
- Status last verified
- Sep 2018
- First submitted
- 30 Jun 2015
- Last updated
- 13 Sep 2018
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Webnovela for Hispanic Dementia Family Caregivers
- ClinicalTrials.gov ID
- NCT02489110
- Acronym / sponsor ID
- Pz-A104a
- Conditions
- Alzheimer's Disease, Dementia
- Keywords
- Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress, Hispanic caregiver
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Photozig, Inc.Industry (pharma, biotech, devices)
- Collaborators
- National Institute on Aging (NIA), Stanford University
- Study start
- Jun 2015
- Primary completion
- May 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 2 Jul 2015 (estimated)
- Results
- Posted 13 Sep 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Photozig and Stanford University are creating a new program for Hispanic dementia caregivers to help cope with caregiving, alleviate related stress, and enhance quality of life for caregivers, with funding from the National Institute on Aging. The program includes a new education online telenovela (Webnovela), online resources, handouts and a DVD (for users without Internet) on how to deal with caregiving stress and handle difficult situations.
Detailed description
The goal of Webnovela program is to evaluate and develop materials for helping caregivers to cope with caregiving, alleviate related distress, and improve their quality of life.
The investigators are evaluating different materials, which may provide caregiving strategies, practical tips and 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.
- Participants will receive links to online resources, related materials and instructions. The investigators ask participants to access the online resources, read provided brochures and guides, and follow the 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Webnovela | Experimental | Behavioral: WebnovelaCaregivers will watch the Webnovela and read related information. The Webnovela is a short online Telenovela in Spanish, specifically designed for Hispanic caregivers on how to cope with dementia caregiving. A DVD will be available to participants without Internet access. |
| Control | Active comparator | Behavioral: InformationCaregivers will be directed to existing web sites, such as NIA Alzheimer's and Dementia Resources in Spanish. Participants will receive related materials in Spanish language. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Care for an individual with Alzheimer's Disease or other dementia.
- Have Internet access or own a DVD player.
- Minimum age of 18 years old.
- Belong to Hispanic/Latino ethnic group.
- 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)
Key exclusion criteria (4 listed)
- Severe psychological or physical illness.
- Inability to read and follow Spanish 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 |
|---|---|---|
| Webnovela | Behavioural | Webnovela |
| Information | Behavioural | Control |
Primary outcome
Stress on the 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. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome.
1 secondary outcome
Caregiver Burden on the Revised Memory and Behavior Problems Checklist
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Dementia Caregiving Program for Hispanic caregiversLink provided by the sponsor.
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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 study testing Webnovela and Information in people with Alzheimer's Disease and Dementia, 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 5 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 13 Sep 2018. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Sep 2018). 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?
Stress on the Perceived Stress Scale (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Sep 2018.