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NCT Number: NCT07269977

mSCI: Mobile Health App for Veterans With SCI and 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.

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Key information

Conditions

Spinal Cord Injuries (SCI) Central Nervous System Diseases Disabled Veterans Families of Veterans Family Caregivers Nervous System Diseases Spinal Cord Diseases Spinal Cord Injuries Spinal Cord Injuries (Complete and Incomplete) Spinal Cord Injury Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location status: Recruiting

Location contact

Bambang Parmanto, PhD

SUB_INVESTIGATOR

Brad Dicianno, MD

SUB_INVESTIGATOR

Yong Choi, PhD, MPH

CONTACT

[email protected]

412-624-6442

Zara Ambadar, Ph.D

CONTACT

[email protected]

(412) 608-6118

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Yong Choi, PhD, MPH

CONTACT

[email protected]

412-624-6442

Zara Ambadar, Ph.D

CONTACT

[email protected]

(412) 608-6118

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Congressionally Directed Medical Research Programs

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Dec 8, 2025
Registry last updated
Dec 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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