mSCI: Mobile Health App for Veterans With SCI and Caregivers

NCT ID: NCT07269977

Last Updated: 2025-12-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-01

Study Completion Date

2029-11-30

Brief Summary

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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

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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

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Spinal Cord Injuries (SCI) Spinal Cord Injury Spinal Cord Injuries (Complete and Incomplete) Family Caregivers Families of Veterans Disabled Veterans

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

OTHER

Study Groups

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Veterans with SCI

Veterans with Spinal Cord Injury

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

Intervention Type OTHER

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

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

Intervention Type OTHER

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

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Congressionally Directed Medical Research Programs

FED

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Yong Choi

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bambang Parmanto, Ph.D

Role: STUDY_DIRECTOR

University of Pittsburgh

Yong Choi, PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yong Choi, PhD, MPH

Role: CONTACT

412-624-6442

Zara Ambadar, Ph.D

Role: CONTACT

(412) 608-6118

Facility Contacts

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Yong Choi, PhD, MPH

Role: primary

412-624-6442

Zara Ambadar, Ph.D

Role: backup

(412) 608-6118

Other Identifiers

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HT94252410748

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

CDMRP-SC230134

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

STUDY24030058

Identifier Type: -

Identifier Source: org_study_id

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