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Webnovela for Hispanic Dementia Family Caregivers

Primary Purpose

Alzheimer's Disease, Dementia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Webnovela
Information
Sponsored by
Photozig, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Alzheimer's Disease focused on measuring Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress, Hispanic caregiver, Latino caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Photozig, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Webnovela

Control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
June 30, 2015
Last Updated
September 11, 2018
Sponsor
Photozig, Inc.
Collaborators
National Institute on Aging (NIA), Stanford University
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1. Study Identification

Unique Protocol Identification Number
NCT02489110
Brief Title
Webnovela for Hispanic Dementia Family Caregivers
Official Title
Webnovela for Hispanic Dementia Family Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
June 2015 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
September 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Photozig, Inc.
Collaborators
National Institute on Aging (NIA), Stanford University

4. Oversight

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alzheimer's Disease, Dementia
Keywords
Alzheimer's Disease, Dementia, caregiving, caregiver, coping, coping with caregiving, stress, Hispanic caregiver, Latino caregiver

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Webnovela
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Webnovela
Intervention Type
Behavioral
Intervention Name(s)
Information
Primary Outcome Measure Information:
Title
Stress on the Perceived Stress Scale
Description
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.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Caregiver Burden on the Revised Memory and Behavior Problems Checklist
Description
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.
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Kajiyama, MS
Organizational Affiliation
Photozig, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Photozig, Inc.
City
Moffett Field
State/Province
California
ZIP/Postal Code
94035-0128
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.miramirela.com
Description
Dementia Caregiving Program for Hispanic caregivers

Learn more about this trial

Webnovela for Hispanic Dementia Family Caregivers

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