SupportGroove App for Spinal Cord Injury

Recruiting at 1 trial location

Overseen By Megan Gardner

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Utah

Disqualifiers: Neurological conditions, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

168 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests a mobile app called SupportGroove designed for people with spinal cord injuries and their romantic partners. The app provides activities to help improve their emotional and mental well-being. Participants will be evaluated periodically to measure the program's effectiveness.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment SupportGroove for spinal cord injury?

The SupportGroove app, designed to help people manage their health after a spinal cord injury, was found to be easy to use and helpful by patients in a study. It received high usability scores, suggesting it could be effective in helping prevent additional health issues after discharge from rehabilitation. ^{1 2 3 4 5}

Is the SupportGroove App safe for use in humans?

There is no specific safety data available for the SupportGroove App itself, but a study on a similar self-management app for spinal cord injury patients found it to be acceptable and easy to use, suggesting it may be safe for human use. ^{1 2 6 7 8}

How does the SupportGroove treatment for spinal cord injury differ from other treatments?

The SupportGroove App for spinal cord injury is unique because it likely involves a digital or app-based approach to treatment, which may offer personalized support and monitoring for patients, unlike traditional physical therapies or medications. This could provide a novel way to enhance patient engagement and track progress in real-time. ^{2 7 9 10 11}

Research Team

Alexandra L Terrill, PhD

Principal Investigator

University of Utah

Eligibility Criteria

This trial is for couples where one partner has a spinal cord injury that happened at least 3 months ago. Both partners must live together, be able to read English, and have access to a smartphone or computer with internet.

Inclusion Criteria

Must be able to read and understand printed English instructions

Must have a smartphone, tablet, or personal computer with internet access

Cohabitating romantic couples where one partner has sustained a spinal cord injury at least 3 months prior to enrolling in the study

Exclusion Criteria

Either partner does not consent to participate in the study

My partner has a spinal cord injury or major neurological condition.

Either partner is unable to read and understand printed English instructions

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Waitlist Control

Participants are waitlisted for 8 weeks before starting the program

8 weeks

SupportGroove Intervention

Participants engage in an 8-week mobile app-based program with daily positive psychology-based activities

8 weeks

Follow-up

Participants are monitored for outcomes such as relationship satisfaction and well-being

20 weeks

Treatment Details

Interventions

• SupportGroove

Trial Overview The study is testing SupportGroove, an 8-week mobile app program designed to help couples manage the challenges of living with a spinal cord injury.

Participant Groups

Group I: SupportGroove Experimental Treatment 1 Intervention

8-week intervention that is remotely delivered through a mobile app, consisting of daily "quests" (positive psychology-based activities) completed individually and as a couple.

Group II: Waitlist control Active Control 1 Intervention

Participants will be waitlisted for 8 weeks.

Who Is Running the Clinical Trial?

University of Utah

Lead Sponsor

Trials

1,169

Recruited

1,623,000+

McGuire Research Institute

Collaborator

Trials

10

Recruited

380+

Findings from Research

A mobile app designed for self-management after spinal cord injury was well-received by 20 inpatient participants, showing high usability scores (78.1/100 at discharge and 71.6/100 three months later).

Participants appreciated the app's accessibility, intuitive navigation, and flexibility, indicating it could be a valuable tool for helping newly injured patients manage their health and prevent secondary conditions after discharge.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. Singh, G., MacGillivray, M., Mills, P., et al.[2020]

Individuals with cervical spinal cord injury (cSCI) believe that wearable cameras can enhance the assessment of upper limb function by providing naturalistic data on hand use, potentially leading to improved rehabilitation therapies.

Participants expressed concerns about discomfort during long recordings and privacy issues, highlighting the need for miniaturized, user-friendly designs and features that allow users to control recordings to ensure their comfort and privacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. Bandini, A., Kalsi-Ryan, S., Craven, BC., et al.[2023]

A survey of 451 individuals with traumatic spinal cord injury revealed that those with high-level tetraplegia were less likely to use tablet and handheld electronic devices compared to individuals with other levels of injury.

Older adults (65 years and older) were also less likely to own or use tablet computers and handheld devices, indicating that age and injury severity influence the adoption of technology among individuals with spinal cord injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic device use by individuals with traumatic spinal cord injury. Mayman, G., Perera, M., Meade, MA., et al.[2018]

Only 30% of the 40 reviewed clinical trials on acute spinal cord injury provided satisfactory reporting of adverse events, indicating a significant gap in safety information that is crucial for assessing risk and designing future studies.

A staggering 82.5% of trials failed to report laboratory-defined toxicity satisfactorily, highlighting the need for improved standards in safety reporting to ensure comprehensive understanding of treatment risks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. Aspinall, P., Harrison, L., Scheuren, P., et al.[2023]

Pregabalin was found to be effective for managing neuropathic pain in chronic spinal cord injury patients, with strong evidence from multiple studies, while cannabinoids were deemed ineffective for the same condition.

Adverse events (AEs) such as dizziness and somnolence were common, leading to withdrawal rates that varied significantly across different medication types, highlighting the need for better reporting of AEs in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. Canavan, C., Inoue, T., McMahon, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Patients' Perspectives on the Usability of a Mobile App for Self-Management following Spinal Cord Injury. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Perspectives and recommendations of individuals with tetraplegia regarding wearable cameras for monitoring hand function at home: Insights from a community-based study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Phosphorylated neurofilament subunit NF-H as a biomarker for evaluating the severity of spinal cord injury patients, a pilot study. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Minimizing errors in acute traumatic spinal cord injury trials by acknowledging the heterogeneity of spinal cord anatomy and injury severity: an observational Canadian cohort analysis. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Electronic device use by individuals with traumatic spinal cord injury. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

A Systematic Review of Safety Reporting in Acute Spinal Cord Injury Clinical Trials: Challenges and Recommendations. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Effects of a trained mobility assistance dog on upper extremity muscular effort during wheelchair propulsion on tiled and carpeted floors in individuals with a spinal cord injury. [2021]

8. England pubmed.ncbi.nlm.nih.gov

The Efficacy, Adverse Events, and Withdrawal Rates of the Pharmacological Management of Chronic Spinal Cord Injury Pain: A Systematic Review and Meta-Analysis. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Detecting destabilizing wheelchair conditions for maintaining seated posture. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a manual wheelchair interface to computer games. [2017]

11. England pubmed.ncbi.nlm.nih.gov

In-lab versus at-home activity recognition in ambulatory subjects with incomplete spinal cord injury. [2022]