ClinicalTrials.gg
RecruitingNCT07269977Updated Sep 15, 2026

mSCI: Mobile Health App for Veterans With SCI and Caregivers

An observational study in Spinal Cord Injuries (SCI), Spinal Cord Injury and Spinal Cord Injuries (Complete and Incomplete), sponsored by University of Pittsburgh. Recruiting at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-15.

Sponsored by University of Pittsburgh · Observational

From the registry’s dates

  • Started Dec 2025; still recruiting 11 months later.
Study type
Observational
Model
Case-only
Time perspective
Other
Enrollment
100
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 10 studies in Spinal Cord Injuries by University of Pittsburgh — 3 open to participants now, 3 under way, none of them phase 3. Spinal Cord Injuries · University of Pittsburgh.

Started
2025
the only one that year
Observational
2 of 10
1 open now
Registered
10th of 10
by date

Among the 10 studies in Spinal Cord Injuries by University of Pittsburgh, this one is the only one that started in 2025, is one of 2 observational ones, and was the 10th registered.

Spinal Cord Injuries

2,025 studies on the registry are indexed under Spinal Cord Injuries; 537 are open to participants now.

Browse Spinal Cord Injuries studies →

Open to participants now

3 of the 10 studies in Spinal Cord Injuries by University of Pittsburgh are open now, in 1 country. Recruiting first, the newest first:

By country, each count listing its studies:

All 3 open studies →

Where they have run

Who these studies take

Of the 375 Spinal Cord Injuries studies recruiting now, 166 (44%) set no upper age limit and 158 (42%) stop at 75 or younger; 41 take children under 18; 52 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 10 studies in Spinal Cord Injuries by University of Pittsburgh, or all of them as a file.
02

Study 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.

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.

03

Conditions studied

  • 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
  • Primary caregiver
  • mobile health app
  • smartphone app
  • Imhere
  • Veterans support
  • paralyzed veterans
  • disabled veterans
  • mobile health support
  • mobile health
  • telemedicine
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 .

Exclusion criteria

Exclusion Criteria:

  • Serious mental illness requiring psychiatric hospitalization
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Observational model
Case-only
Time perspective
Other
Enrollment
100 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: At the end of study participation approximately 6 months after enrollment

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided — Data may be shared with other researchers in an aggregate and de-identified manner

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2025 (actual). Primary completion is estimated for Nov 2029, 47 months after the start.

Of 124 non-industry observational studies under Spinal Cord Injuries, half reached primary completion within 36 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 74. This study's planned 47 months is above that.

Counting every sponsor, half of 135 studies reached it within 39 months; a quarter within 16 and three quarters within 78.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 20, 2025
First posted
Dec 8, 2025
StartActual
Dec 1, 2025
Primary completionEst.
Nov 2029
CompletionEst.
Nov 2029
Last update
Sep 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07269977
Collaborators
Congressionally Directed Medical Research Programs
Responsible party
Yong Choi (Assistant Professor, University of Pittsburgh) — Principal investigator
First posted
Dec 8, 2025
Start date
Dec 1, 2025
Primary completion
Nov 2029 (estimated)
Completion
Nov 2029 (estimated)
Last update
Sep 15, 2026

Study contacts

Yong Choi, PhD, MPH
Contact
yong.choi@pitt.edu
412-624-6442
Zara Ambadar, Ph.D
Contact
ambadar@pitt.edu
(412) 608-6118
Bambang Parmanto, Ph.D
study director · University of Pittsburgh
Yong Choi, PhD, MPH
principal investigator · University of Pittsburgh

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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