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mSCI: Mobile Health App for Veterans With SCI and Caregivers

mSCI: mHealth for Supporting Psychosocial Health of Military Service Members With SCI and Their Family Caregivers

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07269977
Enrollment
100
Registered
2025-12-08
Start date
2025-12-01
Completion date
2029-11-01
Last updated
2026-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Disabled Veterans, Families of Veterans, Family Caregivers, Spinal Cord Injuries (Complete and Incomplete), Spinal Cord Injuries (SCI), Spinal Cord Injury

Keywords

Spinal Cord Injury, Veterans, Veterans with SCI, SCI, SCI/D, Spinal Cord Injuries, Spinal Cord Disorder, Family caregiver, Primary caregiver, mobile health app, smartphone app, Imhere, Veterans support, paralyzed veterans, disabled veterans, mobile health support, mobile health, telemedicine

Brief summary

Caregivers of persons with Spinal Cord Injury (SCI) face increased risk of psychological distress, health problems, reduced quality of life, relationship strain, and restrictions in social and work participation. Military caregivers (Family Caregivers of wounded or disabled Veterans) reported similar negative effects of becoming a caregiver on their physical and mental health. Using results from our previous work in mHealth interventions for individuals with SCI, we developed a dual-target intervention for both individuals with SCI and their caregivers. The overall objective of this research study is to conduct translational research focused on adapting and tailoring the interactive Mobile Health and Rehabilitation (iMHere) 2.0 system to meet the needs of Veterans with SCI and their family caregivers, expanding the psychosocial intervention, and evaluating the feasibility of implementing the iMHere system among Veterans with SCI and their family caregivers.

Detailed description

The overall objective of this project is to conduct translational research focused on adapting and tailoring the iMHere 2.0 system to meet the needs of Veterans with SCI and their FCGs, expanding the psychosocial intervention, and evaluating the feasibility of implementing the iMHere system among Veterans with SCI and their Family Caregivers (FCGs). The specific aims of this project are: Aim 1: To adapt and tailor the iMHere 2.0 system through a codesign process specifically tailored to meet the needs of Veterans with SCI and their FCGs. The iMHere 2.0 system was designed for the general population of individuals with SCI, spina bifida, and cerebral palsy age 12 through adulthood. "Codesign" refers to a participatory approach to designing solutions in which participants are treated as equal collaborators in the design process. Codesign means designing with, not for, the participants (Veterans with SCI and their FCGs). Aim 2: To refine and co-develop the psychosocial dual-target intervention model within iMHere 2.0 to cater specifically to Veterans with SCI and their FCGs. We have conducted preliminary work on psychosocial interventions both for caregivers and care recipients. In this aim, we plan to expand the existing interventions by combining the materials that have been developed in the previous projects with co-design process of Aim 1 to achieve a user-centered, dual-target intervention that meets the needs of Veterans with SCI and their FCGs. Aim 3: To conduct a study to evaluate usability and feasibility of implementing the iMHere 2.0 system among Veterans with SCI and their caregivers. We plan to implement the adapted and expanded iMHere 2.0 system (the result of Aims 1 and 2) among Veterans with SCI and their FCGs in a consumer model of delivery. This includes a variety of care models where iMHere can be implemented: medical, community based, and consumer. In a consumer model, Veterans with SCI and their FCGs will use the iMHere system as a consumer tool outside the medical system.

Interventions

OTHERiMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregivers

iMHere is a mobile health technology designed to support veterans with SCI and their caregivers.

Sponsors

University of Pittsburgh
Lead SponsorOTHER
Congressionally Directed Medical Research Programs
CollaboratorFED

Study design

Observational model
CASE_ONLY
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Veterans with SCI or Family caregivers of Veterans with SCI * Have access to the Internet and a computer to participate in a Zoom call * Able to speak and understand English to provide informed consent.

Exclusion criteria

* Serious mental illness requiring psychiatric hospitalization

Design outcomes

Primary

MeasureTime frameDescription
Ratio of actionable feedback to system integrationFrom enrollment to end of study completion approximately 6 monthsThe study will collect actionable feedback and the needs of veterans with SCI and their family caregivers and implement them into the iMHere Mobile Health App system. We will measure the ratio between actionable feedback and needs of veterans with SCI and their family caregivers to the system integration.

Secondary

MeasureTime frameDescription
Participant SatisfactionAt the end of study participation approximately 6 months after enrollmentThis is a qualitative data, no quantifiable metric(s) will be used. We will gather participants' satisfaction of the result of the codesign process to evaluate how well the implementation of the actionable feedback reflects the perspective and needs of veterans with SCI and their caregivers. This outcome will be collected using interviews that includes questions about usability, acceptability, and utilization of the system. The interview will also identify barriers and facilitators of the iMHere adoption by Veterans with SCI and their family caregivers.

Countries

United States

Contacts

CONTACTYong Choi, PhD, MPH
yong.choi@pitt.edu412-624-6442
CONTACTZara Ambadar, Ph.D
ambadar@pitt.edu(412) 608-6118
STUDY_DIRECTORBambang Parmanto, Ph.D

University of Pittsburgh

PRINCIPAL_INVESTIGATORYong Choi, PhD, MPH

University of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 16, 2026