NCT02489110

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 2, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
2 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

September 1, 2018

Enrollment Period

11 months

First QC Date

June 30, 2015

Results QC Date

August 13, 2018

Last Update Submit

September 11, 2018

Conditions

Alzheimer's DiseaseDementia

Keywords

Alzheimer's DiseaseDementiacaregivingcaregivercopingcoping with caregivingstressHispanic caregiverLatino caregiver

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Secondary Outcomes (1)

  • Caregiver Burden on the Revised Memory and Behavior Problems Checklist

    3 months

Study Arms (2)

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.

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.

Behavioral: Information

Interventions

WebnovelaBEHAVIORAL
Webnovela
InformationBEHAVIORAL
Control

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Photozig, Inc.

Moffett Field, California, 94035-0128, United States

Location

Related Links

MeSH Terms

Conditions

Alzheimer DiseaseDementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative DiseasesNeurocognitive DisordersMental Disorders

Results Point of Contact

Title
Bruno Kajiyama
Organization
Photozig, Inc.
info@photozig.com
6506947595

Study Officials

  • Bruno Kajiyama, MS

    Photozig, Inc.

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
CEO

Study Record Dates

First Submitted

June 30, 2015

First Posted

July 2, 2015

Study Start

June 1, 2015

Primary Completion

May 1, 2016

Study Completion

September 1, 2016

Last Updated

September 13, 2018

Results First Posted

September 13, 2018

Record last verified: 2018-09

Locations

US(1)