- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02489110
Webnovela for Hispanic Dementia Family Caregivers
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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California
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Moffett Field, California, United States, 94035-0128
- Photozig, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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.
Study Plan
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 |
---|---|
Experimental: Webnovela
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.
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Active Comparator: Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Caregiver Burden on the 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
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pz-A104a
- R44AG041552 (U.S. NIH Grant/Contract)
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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