Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers

Study Overview
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Brief Summary
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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
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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

Official Title
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Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers

Conditions
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Military Family, Mental Health Disorder, Social Skills, Social Isolation, Communication, Quality of Life

Intervention / Treatment
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* Behavioral: avatar-based training


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receives the full program, including the toolkit training and avatar interaction | Behavioral: avatar-based training<br>* Interaction with an avatar-based module to practice skills learned during the toolkit training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| World Health Organization Quality of Life - Brief | World Health Organization Quality of Life-Brief version (WHOQOL-BREF). The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF (Field Trial Version) produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score - | Assess changes between baseline and 3 & 6 month follow-ups | 
| Social support | Multidimensional Scale of Perceived Social Support, military version. Multidimensional Scale of Perceived Social Support (MSPSS). The MSPSS (Zimet et al., 1988) is a 12-item self-report measure that inquires about three dimensions of social relationships (family, friends, and a significant other) on a 7-point Likert-type scale (1 = very strongly disagree to 7 = very strongly agree). Higher scores on each of the subscales indicate higher levels of perceived support. A Global satisfaction with perceived support score can be obtained by taking the sum of the three scales. The current study added a fourth dimension relevant to military personnel that assessed sources of social support from military peers. | Assess changes between baseline and 3 & 6 month follow-ups | 
| Depression | Patient health questionnaire (PHQ)-2. Frequency of depressive symptoms were assessed with the 2-item Patient Health Questionnaire (PHQ-2). Items are rated on a 4-point scale from 0-3; higher scores indicate greater symptoms. Respondents then indicate the difficulty the symptoms have made their life on a 4 point scale, where high scores indicate greater difficulty. | Assess changes between baseline and 3 & 6 month follow-ups | 
| Anxiety | Generalized anxiety disorder-7.Frequency of anxiety symptoms were assessed using the 7-item Generalized Anxiety Disorder (GAD-7) (34). Items are rated on a 4-point scale, where 5, 10, and 15 are used as cutoffs for mild, moderate, and severe anxiety, respectively. Higher scores indicate greater symptoms | Assess changes between baseline and 3 & 6 month follow-ups | 
| Caregiver somatic symptoms | PATIENT HEALTH QUESTIONNAIRE (PHQ-15). For scoring, response options for these two symptoms are coded as 0 (not at all), 1 (several days), or 2 (more than half the days or nearly every day). Thus, the total PHQ-15 score ranges from 0 to 30 and scores of ≥5, ≥10, ≥15 represent mild, moderate and severe levels of somatization. | Assess changes between baseline and 3 & 6 month follow-ups | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wounded warrior quality of life and health status | World Health Organization Quality of Life-Brief version (WHOQOL-BREF). The WHOQOL-BREF instrument comprises 26 items, which measure the following broad domains: physical health, psychological health, social relationships, and environment. The WHOQOL-BREF is a shorter version of the original instrument that may be more convenient for use in large research studies or clinical trials. The WHOQOL-BREF (Field Trial Version) produces a quality of life profile. It is possible to derive four domain scores. There are also two items that are examined separately: question 1 asks about an individual's overall perception of quality of life and question 2 asks about an individual's overall perception of their health. The four domain scores denote an individual's perception of quality of life in each particular domain. Domain scores are scaled in a positive direction (i.e. higher scores denote higher quality of life). The mean score of items within each domain is used to calculate the domain score - | Assess changes between baseline and 3 & 6 month follow-ups | 
| Caregiver knowledge | 12 items assessing participant knowledge of caregiving. Items are rated on a 5-point scale where higher scores indicate higher knowledge of caregiving skills and responsibilities. | Assess changes between baseline and 3 & 6 month follow-ups | 
| wounded warrior depression | Patient health questionnaire (PHQ)-2. Frequency of depressive symptoms were assessed with the 2-item Patient Health Questionnaire (PHQ-2). Items are rated on a 4-point scale from 0-3; higher scores indicate greater symptoms. Respondents then indicate the difficulty the symptoms have made their life on a 4 point scale, where high scores indicate greater difficulty. | Assess changes between baseline and 3 & 6 month follow-ups | 
| wounded warrior anxiety | Generalized anxiety disorder-7.Frequency of anxiety symptoms were assessed using the 7-item Generalized Anxiety Disorder (GAD-7) (34). Items are rated on a 4-point scale, where 5, 10, and 15 are used as cutoffs for mild, moderate, and severe anxiety, respectively. Higher scores indicate greater symptoms | Assess changes between baseline and 3 & 6 month follow-ups | 
| wounded warrior somatic symptoms | PATIENT HEALTH QUESTIONNAIRE (PHQ-15). For scoring, response options for these two symptoms are coded as 0 (not at all), 1 (several days), or 2 (more than half the days or nearly every day). Thus, the total PHQ-15 score ranges from 0 to 30 and scores of ≥5, ≥10, ≥15 represent mild, moderate and severe levels of somatization. | Assess changes between baseline and 3 & 6 month follow-ups | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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military, caregiver