NCT07269977

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
43mo left

Started Dec 2025

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress11%
Dec 2025Nov 2029

First Submitted

Initial submission to the registry

November 20, 2025

Completed
11 days until next milestone

Study Start

First participant enrolled

December 1, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 8, 2025

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2029

Last Updated

December 12, 2025

Status Verified

December 1, 2025

Enrollment Period

3.9 years

First QC Date

November 20, 2025

Last Update Submit

December 5, 2025

Conditions

Spinal Cord Injuries (SCI)Spinal Cord InjurySpinal Cord Injuries (Complete and Incomplete)Family CaregiversFamilies of VeteransDisabled Veterans

Keywords

Spinal Cord InjuryVeteransVeterans with SCISCISCI/DSpinal Cord InjuriesSpinal Cord DisorderFamily caregiverPrimary caregivermobile health appsmartphone appImhereVeterans supportparalyzed veteransdisabled veteransmobile health supportmobile healthtelemedicine

Outcome Measures

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.

    From enrollment to end of study completion approximately 6 months

Secondary Outcomes (1)

  • Participant Satisfaction

    At the end of study participation approximately 6 months after enrollment

Study Arms (2)

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

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.

Primary Caregivers of Veterans with SCIVeterans with SCI

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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.

You may not qualify if:

  • Serious mental illness requiring psychiatric hospitalization

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

RECRUITING

MeSH Terms

Conditions

Spinal Cord InjuriesSpinal Cord Diseases

Condition Hierarchy (Ancestors)

Central Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and Injuries

Study Officials

  • Bambang Parmanto, Ph.D

    University of Pittsburgh

    STUDY DIRECTOR

  • Yong Choi, PhD, MPH

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yong Choi, PhD, MPH

CONTACT

412-624-6442yong.choi@pitt.edu

Zara Ambadar, Ph.D

CONTACT

(412) 608-6118ambadar@pitt.edu

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 20, 2025

First Posted

December 8, 2025

Study Start

December 1, 2025

Primary Completion (Estimated)

November 1, 2029

Study Completion (Estimated)

November 1, 2029

Last Updated

December 12, 2025

Record last verified: 2025-12

Locations

US(1)