Trial Outcomes & Findings for Webnovela for Hispanic Dementia Family Caregivers (NCT NCT02489110)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

150 participants

Primary outcome timeframe

3 months

Results posted on

2018-09-13

Participant Flow

Participant milestones

Participant milestones
Measure	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. Webnovela	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. Information
Overall Study STARTED	75	75
Overall Study COMPLETED	48	50
Overall Study NOT COMPLETED	27	25

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Webnovela for Hispanic Dementia Family Caregivers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Webnovela n=75 Participants 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. Webnovela	Control n=75 Participants 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. Information	Total n=150 Participants Total of all reporting groups
Age, Continuous	54.2 years STANDARD_DEVIATION 11.2 • n=5 Participants	51.5 years STANDARD_DEVIATION 9.4 • n=7 Participants	52.9 years STANDARD_DEVIATION 10.4 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	65 Participants n=7 Participants	129 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	10 Participants n=7 Participants	21 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	75 Participants n=5 Participants	75 Participants n=7 Participants	150 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: One (1) subject in the Webnovela group and one (1) subject in the Control group completed the study, but they did not have full data related to the Primary Outcome "Stress on the Perceived Stress Scale." These subjects were not included in this data analysis.

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.

Outcome measures

Outcome measures
Measure	Webnovela n=47 Participants 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. Webnovela	Control n=49 Participants 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. Information
Stress on the Perceived Stress Scale	14.57 units on a scale Standard Deviation 5.54	15.37 units on a scale Standard Deviation 5.89

SECONDARY outcome

Timeframe: 3 months

Population: Two (2) subjects in the Webnovela group completed the study, but they did not have full data related to the Secondary Outcome "Caregiver Burden on the Revised Memory and Behavior Problems Checklist." These subjects were not included in this data analysis.

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.

Outcome measures

Outcome measures
Measure	Webnovela n=46 Participants 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. Webnovela	Control n=50 Participants 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. Information
Caregiver Burden on the Revised Memory and Behavior Problems Checklist	0.51 units on a scale Standard Deviation 0.57	0.60 units on a scale Standard Deviation 0.86

Adverse Events

Webnovela

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Bruno Kajiyama

Photozig, Inc.

Phone: 6506947595

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place