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

NCT03336190 | Completed

• 1 other identifier: UP-17-00273
• Study Type: interventional
• Target: 124
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

military; caregiver

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (5)

• Wounded warrior quality of life and health status

  Assess changes between baseline and 3 & 6 month follow-ups

• Caregiver knowledge

  Assess changes between baseline and 3 & 6 month follow-ups

• wounded warrior depression

  Assess changes between baseline and 3 & 6 month follow-ups

• wounded warrior anxiety

  Assess changes between baseline and 3 & 6 month follow-ups

• wounded warrior somatic symptoms

  Assess changes between baseline and 3 & 6 month follow-ups

Other Outcomes (9)

• Costs of care

  Assess changes between baseline and 3 & 6 month follow-ups

• Common stressors

  Assess changes between baseline and 3 & 6 month follow-ups

• Relationship satisfaction and intimacy

  Assess changes between baseline and 3 & 6 month follow-ups

Study Arms (1)

Intervention

EXPERIMENTAL

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

Behavioral: avatar-based training

Interventions

avatar-based training BEHAVIORAL

Interaction with an avatar-based module to practice skills learned during the toolkit training

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Southern California: lead
• Blue Star Families: collaborator
• Uniformed Services University of the Health Sciences: collaborator
• Wilcox Research: collaborator

Study Sites (1)

Uniformed Services University of the Health Sciences

Bethesda, Maryland, 20814, United States

Location

MeSH Terms

Conditions

Mental Disorders; Social Skills; Social Isolation; Communication

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 8, 2017
• Study Start: June 24, 2017
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: October 21, 2022

Record last verified: 2022-10

Locations

US (1)