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

October 19, 2022 updated by: Sherrie Wilcox, University of Southern California
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
124

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20814
        • Uniformed Services University of the Health Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention
Receives the full program, including the toolkit training and avatar interaction
Behavioral: avatar-based training
Interaction with an avatar-based module to practice skills learned during the toolkit training

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
World Health Organization Quality of Life - Brief
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Wounded warrior quality of life and health status
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Costs of care
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
Common stressors
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
Relationship satisfaction and intimacy
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
medical outcomes
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
Wounded warrior satisfaction of care
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
barriers to care
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
wounded warriors injury & pain
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
relationship happiness
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
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.
Assess changes between baseline and 3 & 6 month follow-ups
Relationship quality
Time Frame: Assess changes between baseline and 3 & 6 month follow-ups
Relationship quality with a single item, "We have a good marriage/partnership" rated on a 5 point scale where higher scores indicate greater happiness.
Assess changes between baseline and 3 & 6 month follow-ups

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Uniformed Services University of the Health Sciences
Blue Star Families
Wilcox Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 24, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 2, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 7, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 8, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 21, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 19, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • UP-17-00273

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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Sponsor/Collaborators

Locations

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