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Webnovela for Hispanic Dementia Family Caregivers

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02489110
Recruitment Status : Completed
First Posted : July 2, 2015
Results First Posted : September 13, 2018
Last Update Posted : September 13, 2018
Sponsor:
Collaborators:
National Institute on Aging (NIA)
Stanford University
Information provided by (Responsible Party):
Bruno Kajiyama, Photozig, Inc.

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Alzheimer's Disease Dementia Behavioral: Webnovela Behavioral: Information Not Applicable

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:

  1. 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).
  2. A Program survey will be sent, which can be completed online, or returned in a pre-mailed envelope.
  3. 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.
  4. After completing the program, the second and final survey should be filled out online or returned by pre-mailed envelope.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Webnovela for Hispanic Dementia Family Caregivers
Study Start Date : June 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : September 2016


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.
Behavioral: Webnovela
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.
Behavioral: Information



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02489110


Locations
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United States, California
Photozig, Inc.
Moffett Field, California, United States, 94035-0128
Sponsors and Collaborators
Photozig, Inc.
National Institute on Aging (NIA)
Stanford University
Investigators
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Principal Investigator: Bruno Kajiyama, MS Photozig, Inc.
Additional Information:
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Responsible Party: Bruno Kajiyama, CEO, Photozig, Inc.
ClinicalTrials.gov Identifier: NCT02489110    
Other Study ID Numbers: Pz-A104a
R44AG041552 ( U.S. NIH Grant/Contract )
First Posted: July 2, 2015    Key Record Dates
Results First Posted: September 13, 2018
Last Update Posted: September 13, 2018
Last Verified: September 2018
Keywords provided by Bruno Kajiyama, Photozig, Inc.:
Alzheimer's Disease
Dementia
caregiving
caregiver
coping
coping with caregiving
stress
Hispanic caregiver
Latino caregiver
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders