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

Primary Purpose

Military Family, Mental Health Disorder, Social Skills

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
avatar-based training
Sponsored by
University of Southern California
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Military Family focused on measuring military, caregiver

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Uniformed Services University of the Health Sciences

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention

Arm Description

Receives the full program, including the toolkit training and avatar interaction

Outcomes

Primary Outcome Measures

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 -
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.
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.
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
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.

Secondary Outcome Measures

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 -
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.
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.
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
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.

Full Information

First Posted
November 2, 2017
Last Updated
October 19, 2022
Sponsor
University of Southern California
Collaborators
Blue Star Families, Uniformed Services University of the Health Sciences, Wilcox Research
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1. Study Identification

Unique Protocol Identification Number
NCT03336190
Brief Title
Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers
Acronym
BSC
Official Title
Blue Star Cares: Innovative Approaches to Helping Military-Connected Caregivers
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
June 24, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Southern California
Collaborators
Blue Star Families, Uniformed Services University of the Health Sciences, Wilcox Research

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Military Family, Mental Health Disorder, Social Skills, Social Isolation, Communication, Quality of Life
Keywords
military, caregiver

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
124 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Receives the full program, including the toolkit training and avatar interaction
Intervention Type
Behavioral
Intervention Name(s)
avatar-based training
Intervention Description
Interaction with an avatar-based module to practice skills learned during the toolkit training
Primary Outcome Measure Information:
Title
World Health Organization Quality of Life - Brief
Description
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 -
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Social support
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Depression
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Anxiety
Description
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
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Caregiver somatic symptoms
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Secondary Outcome Measure Information:
Title
Wounded warrior quality of life and health status
Description
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 -
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Caregiver knowledge
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
wounded warrior depression
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
wounded warrior anxiety
Description
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
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
wounded warrior somatic symptoms
Description
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.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Other Pre-specified Outcome Measures:
Title
Costs of care
Description
Costs of care. Costs of care will be calculated based upon extent of injuries, frequency of visits, and projected annual costs based upon responses to outcomes across the study.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Common stressors
Description
Checklist of 14 common stressors. A checklist of 14 common stressors rated on a 10 point scale where higher scores indicate greater stress. Items included marital conflict, family conflict, and problems being a caregiver.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Relationship satisfaction and intimacy
Description
RELATIONSHIP ASSESSMENT SCALE. A 7-item scale designed to measure general relationship satisfaction. Respondents answer each item using a 5-point scale ranging from 1 (low satisfaction) to 5 (high satisfaction). Items 4 and 7 are reverse-scored. Scoring is kept continuous. The higher the score, the more satisfied the respondent is with his/her relationship.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
medical outcomes
Description
12-Item Short Form Survey (SF-12). SF-12 measures physical functioning, role limitation due to physical health problems, bodily pain, general health, vitality, social functioning, role limitation due to emotional problems, and mental health. 2 items are used to estimate scores for four of the 8 health concepts (physical functioning: 0-5 where higher indicates more limited), role-physical: 0-3 where higher indicates more limited, role-emotional: 0-3 where higher indicates more limited, mental health: 0-11 where higher indicates more problems). Scores for the remaining 4 (bodily pain: 0-4 where higher indicates more problems, general health: 0-4 where higher indicates more problems, vitality, and social functioning: 0-4 where higher indicates more problems) are estimated using a single item each.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Wounded warrior satisfaction of care
Description
Patient Satisfaction Questionnaire 18 (PSQ-18). The short-form instrument, the PSQ-18, contains 18 items tapping each of the seven dimensions of satisfaction with medical care measured by the PSQ-III: general satisfaction (0-5, higher equals more disagreement), technical quality (0-5, higher equals more disagreement), interpersonal manner (0-5, higher equals more disagreement), communication (0-5, higher equals more disagreement), financial aspects (0-5, higher equals more disagreement), time spent with doctor (0-5, higher equals more disagreement), and accessibility and convenience (0-5, higher equals more disagreement). Items are rated on a 5 point scale where higher scores indicate more disagreement.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
barriers to care
Description
15 item barriers to care survey. Respondents were asked about their use of professional physical or mental health services and about perceived barriers to physical and mental health treatment, particularly stigmatization as a result of receiving such treatment. Items are rated on a 2 point scale where higher scores indicate barriers. Overall scores range from 0-15 where higher scores indicate more barriers.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
wounded warriors injury & pain
Description
Pain and injury checklist. Physical injuries were assessed with a 22-item checklist of body parts indicated on an image. Respondents could check locations of injuries. Number of injuries ranged from 0-22, where high scores indicate more injuries. Pain was rated on a 10-point scale where higher scores indicate more pain.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
relationship happiness
Description
Relationship happiness with a single item, "Please slide the bar to the number, which best describes the degree of happiness, all things considered of your relationship" from 0-7 where higher scores indicate greater happiness.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups
Title
Relationship quality
Description
Relationship quality with a single item, "We have a good marriage/partnership" rated on a 5 point scale where higher scores indicate greater happiness.
Time Frame
Assess changes between baseline and 3 & 6 month follow-ups

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Uniformed Services University of the Health Sciences
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20814
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
Unidentified data may be requested by emailing the Principal Investigator the specific research questions, variables of interest, analysis plan, and dissemination plan. Requests may be made at the completion of the study, once the main study questions have been evaluated and published.

Learn more about this trial

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

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