Virtual Patient Behavioral Response Training for Family Caregivers

Study Overview
=================
Brief Summary
-----------------
Our study is designed to help caregivers of someone with Alzheimer's Disease and related dementia to understand and deal with the difficult behaviors of a person with dementia.

Detailed Description
-----------------
The goal of this study is to develop and evaluate the Caring Response mobile app, containing a training that builds skills and stimulates practice. The investigators are evaluating different materials, which may encourage caregiver participation, enable user interaction, and promote better assimilation of concepts. The research team is designing the program to help to enhance caregivers' skills to deal with difficult behaviors, reduce distress, and improve quality of life.

Official Title
-----------------
Virtual Patient Behavioral Response Training for Family Caregivers

Conditions
-----------------
Alzheimer Disease

Intervention / Treatment
-----------------
* Behavioral: Caring Response App
* Behavioral: Traditional Educational/Resources Program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Care for an individual with Alzheimer's Disease or other dementia. Own a smartphone or tablet and have Internet access. Minimum age of 18 years old. Spend at least 8 hours/week caring for a person with dementia. Exclusion Criteria: Severe psychological or physical illness. Inability to read and follow English instructions. High level of depressive symptoms. Unwillingness to participate in all aspects of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Patient Behavioral Response Training<br>Caring Response mobile app with a behavioral training. | Behavioral: Caring Response App<br>* Participants will receive the Caring Response mobile app containing the Virtual Patient Behavioral Response Training.<br>|
| Active Comparator: Educational Training<br>Traditional educational program. | Behavioral: Traditional Educational/Resources Program<br>* Participants will receive a traditional educational/resources program, containing a workbook and online resources.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 3 months | 
| Center for Epidemiological Studies Depression Scale | The Center for Epidemiological Studies Depression scale (CES-D) is a 20-item measure that asks about the frequency of depressive symptoms (affective, psychological, and somatic) within the past week.The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=60. Higher values represent a worse outcome. | 3 months | 
| 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. The scale refers to the caregiver. Minimum score (best value)=0. Maximum score (worst value)=40. Higher values represent a worse outcome. | 3 months |