Spinal Cord Injuries (SCI)NCT07269977
mSCI: Mobile Health App for Veterans With SCI and Caregivers
An observational study of Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Cord Injuries (Complete and Incomplete)
- What is being tested?
- iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregivers
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2025to Nov 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Participants can reside anywhere in the US because the study is conducted remotely via Zoom.
Who may be able to join
- 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.
Who cannot join
- Serious mental illness requiring psychiatric hospitalization
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
Yong Choi, PhD, MPH, 412-624-6442, yong.choi@pitt.edu
Zara Ambadar, Ph.D, (412) 608-6118, ambadar@pitt.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Cord Injuries (Complete and Incomplete), Family Caregivers, Families of Veterans, Disabled Veterans
- Being tested
- iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregivers
- 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
- Medical subject headings
- Spinal Cord Injuries, Spinal Cord Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregiversOther
iMHere is a mobile health technology designed to support veterans with SCI and their caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Veterans with SCI | Veterans with Spinal Cord Injury Receives: Other: iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregivers | |
| Primary Caregivers of Veterans with SCI | Family member who is the main (primary) caregiver of the veterans with SCI Receives: Other: iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregivers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ratio of actionable feedback to system integration
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.
Measured: From enrollment to end of study completion approximately 6 months
Secondary outcomes (1)
Participant Satisfaction
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.
Measured: At the end of study participation approximately 6 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Dec 2025
- Study start1 Dec 2025
- Primary completionNov 2029 (estimated)
- Study completionNov 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injuries (SCI)Studies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Other
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Responsible party
- Principal investigator, Yong Choi, University of Pittsburgh
- Investigators
- Bambang Parmanto, Ph.D, Study director, University of PittsburghYong Choi, PhD, MPH, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07269977
- Sponsor's protocol ID
- STUDY24030058
- Other IDs
- HT94252410748, CDMRP-SC230134
- Status last verified
- Sep 2026
- First submitted
- 20 Nov 2025
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Data may be shared with other researchers in an aggregate and de-identified manner
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- mSCI: mHealth for Supporting Psychosocial Health of Military Service Members With SCI and Their Family Caregivers
- ClinicalTrials.gov ID
- NCT07269977
- Acronym / sponsor ID
- STUDY24030058
- Conditions
- Spinal Cord Injuries (SCI), Spinal Cord Injury, Spinal Cord Injuries (Complete and Incomplete), Family Caregivers, Families of Veterans, Disabled Veterans
- Keywords
- Spinal Cord Injury, Veterans, Veterans with SCI, SCI, SCI/D, Spinal Cord Injuries, Spinal Cord Disorder, Family caregiver
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Congressionally Directed Medical Research Programs
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- Nov 2029 (estimated)
- Study completion
- Nov 2029 (estimated)
- First posted
- 8 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Veterans with SCI | – | Other: iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregiversVeterans with Spinal Cord Injury |
| Primary Caregivers of Veterans with SCI | – | Other: iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregiversFamily member who is the main (primary) caregiver of the veterans with SCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Participants can reside anywhere in the US because the study is conducted remotely via Zoom.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Serious mental illness requiring psychiatric hospitalization
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iMHERE 2.0. A mobile health App designed to support veterans with SCI manage their self care, and their caregiversiMHere is a mobile health technology designed to support veterans with SCI and their caregivers. | Other | Primary Caregivers of Veterans with SCI, Veterans with SCI |
Primary outcome
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.
1 secondary outcome
Participant Satisfaction
Time frame: At the end of study participation approximately 6 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: Undecided. Data may be shared with other researchers in an aggregate and de-identified manner
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bambang Parmanto, Ph.D study director
University of Pittsburgh
Yong Choi, PhD, MPH principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injuries (SCI) and Spinal Cord Injury, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yong Choi, PhD, MPH (412-624-6442, yong.choi@pitt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ratio of actionable feedback to system integration (time frame: From enrollment to end of study completion approximately 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2026.