Clinical trial NCT03336190: Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers
Official title: Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Military Family
Mental Health Disorder
Social Skills
Social Isolation
Communication
Quality of Life
Keywords: military
caregiver
Lead sponsor: University of Southern California
Sponsor class: OTHER
Collaborators: name: Blue Star Families
name: Uniformed Services University of the Health Sciences
name: Wilcox Research
First posted: 2017-11-08
Enrollment: 124
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief summary: The purpose of this project is to evaluate an interactive training program for military-connected caregivers (MCCs) of wounded warriors. The program leverages existing resources and incorporates evidence-based training and peer-based support networks to enhance continuity of care. The program consists of an educational Toolkit (workbook) and an avatar training interaction where an MCC can practice skills learned from the toolkit training with the avatar (how to navigate difficult conversations). This is an educational training evaluation to determine whether or not avatar interaction can effectively improve health outcomes in MCCs.

Detailed description: The purpose of this project is to evaluate an interactive training program for military-connected caregivers (MCCs) of wounded warriors. The program leverages existing resources and incorporates evidence-based training and peer-based support networks to enhance continuity of care. The program consists of an educational Toolkit (workbook) and an avatar training interaction where an MCC can practice skills learned from the toolkit training with the avatar (how to navigate difficult conversations). This is an educational training evaluation to determine whether or not avatar interaction can effectively improve health outcomes in MCCs.

The investigators will implement a pre-post design looking at a group of caregivers across multiple time points examining differences in outcomes from baseline (before engaging in the training/intervention) to after completing the training, including follow-ups at 3- and 6-months to evaluate longer-term outcomes.Those enrolled in the intervention will receive the complete training program (toolkit and avatar).

Project participants (i.e., MCCs who engage in the training and follow-up activities) will receive the (a) training toolkit workshop and will engage with the avatar to practice the knowledge and skills described in the workshop or will receive only the (b) training toolkit workshop (control).

Comparing the time differences will enable us to determine if the training program, specifically the avatar interaction, is associated with improved health and quality of life in caregivers of wounded warriors, enhanced caregiver social support and networks, improved patient (wounded warrior) experience of care, and reduced per capita costs of care for both the wounded warrior and caregiver.

Follow-up focus groups and interviews will be conducted to assess caregiver participant perspectives on what worked, what did not work, what they would like to see in the future, how the avatar interaction impacted them, and how the program could be improved in the future, as well as to clarify findings

Eligibility criteria: Inclusion Criteria:

* Participants must be a military-connected caregiver over the age of 18.

Exclusion Criteria:

* Participants under the age of 18 or not a military-connected caregiver. Active duty military personnel are unable to participate in this project.

Primary outcomes:
measure: World Health Organization Quality of Life - Brief
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Social support
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Depression
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Anxiety
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Caregiver somatic symptoms
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
Secondary outcomes:
measure: Wounded warrior quality of life and health status
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Caregiver knowledge
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: wounded warrior depression
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: wounded warrior anxiety
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: wounded warrior somatic symptoms
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
Other outcomes:
measure: Costs of care
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Common stressors
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Relationship satisfaction and intimacy
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: medical outcomes
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Wounded warrior satisfaction of care
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: barriers to care
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: wounded warriors injury & pain
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: relationship happiness
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
measure: Relationship quality
timeFrame: Assess changes between baseline and 3 & 6 month follow-ups
Locations:
city: Bethesda
country: United States
facility: Uniformed Services University of the Health Sciences
state: Maryland
Study officials:
References: