mSCI: Mobile Health App for Veterans With SCI and Caregivers

December 5, 2025 updated by: Yong Choi, University of Pittsburgh

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15260
        • Recruiting
        • University of Pittsburgh
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bambang Parmanto, PhD
        • Sub-Investigator:
          • Brad Dicianno, MD

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

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Participants can reside anywhere in the US because the study is conducted remotely via Zoom.

Description

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

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Veterans with SCI
Veterans with Spinal Cord Injury
Other: iMHERE 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.
Primary Caregivers of Veterans with SCI
Family member who is the main (primary) caregiver of the veterans with SCI
Other: iMHERE 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Ratio of actionable feedback to system integration
Time Frame: From enrollment to end of study completion approximately 6 months
The 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.
From enrollment to end of study completion approximately 6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Participant Satisfaction
Time Frame: At the end of study participation approximately 6 months after enrollment
This 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.
At the end of study participation approximately 6 months after enrollment

Collaborators and Investigators

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

Sponsor

University of Pittsburgh

Collaborators

Congressionally Directed Medical Research Programs

Investigators

  • Study Director: Bambang Parmanto, Ph.D, University of Pittsburgh
  • Principal Investigator: Yong Choi, PhD, MPH, University of Pittsburgh

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)

December 1, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Study Registration Dates

First Submitted

November 20, 2025

First Submitted That Met QC Criteria

November 25, 2025

First Posted (Estimated)

December 8, 2025

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 5, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY24030058
  • HT94252410748 (Other Grant/Funding Number: US Army Medical Research and Materiel Command (USAMRMC))
  • CDMRP-SC230134 (Other Grant/Funding Number: Congressionally Directed Medical Research Programs)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Data may be shared with other researchers in an aggregate and de-identified manner

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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