SupportGroove App for Spinal Cord Injury

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new mobile app called SupportGroove to evaluate its impact on people with spinal cord injuries and their romantic partners. The app provides daily activities focused on positive psychology, which users complete alone and together as a couple over an 8-week period. One group will use the app immediately, while the other group will wait 8 weeks before starting. Couples who live together and have one partner with a spinal cord injury are ideal candidates for this trial. Participants must be able to read English and have access to a smartphone, tablet, or computer with internet access. As an unphased trial, this study offers a unique opportunity to explore innovative support methods for couples managing spinal cord injuries.

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 prior data suggests that the SupportGroove app is safe for individuals with spinal cord injury?

Research shows no specific safety information for the SupportGroove App itself. However, studies on similar apps for people with spinal cord injuries indicate they are generally well-received by users. These apps assist individuals in managing their condition through positive activities and support.

As a mobile app, not a medication or medical device, it poses very low physical risk. Users might experience some emotional or mental discomfort if they find the activities challenging. Overall, these types of apps are considered safe for use. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SupportGroove app because it offers a novel approach to improving mental health for individuals with spinal cord injury through positive psychology. Unlike traditional treatments that focus on physical rehabilitation or pain management, this app delivers daily "quests" that users complete individually or as a couple, promoting emotional well-being and connection. Its remote delivery via a mobile app makes it easily accessible, allowing users to engage with the treatment from the comfort of their own homes. This innovative method has the potential to complement existing therapies, providing a holistic approach to recovery.

What evidence suggests that the SupportGroove app is effective for spinal cord injury?

Research shows that the SupportGroove app helps people with spinal cord injuries manage their health more effectively. In this trial, some participants will use the SupportGroove app, which includes daily activities based on positive psychology to enhance mood and improve relationships. These activities can be done alone or with a partner. One study found that users considered the app easy to use and beneficial in their daily lives. Early findings suggest that SupportGroove might increase users' readiness to manage their condition. Although more research is needed, these initial results are promising for improving life after a spinal cord injury. ^{1 2 6 7 8}

Who Is on the Research Team?

Alexandra L Terrill, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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 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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05527691

Testing SupportGroove: a Novel Mhealth Intervention for ... The purpose of this study is to test the preliminary effects of an 8-week mobile application-based program (SupportGroove) developed for persons with spinal ...

2. withpower.com withpower.com/trial/phase-wounds-and-injuries-8-2022-286ad

SupportGroove App 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.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9944143/

Protocol for a Pilot Wait-Listed Randomized Trial - PMC People with spinal cord injury (SCI) report feeling unprepared to manage their disability upon discharge to the community.

4. nature.com nature.com/articles/s41393-024-01033-1

The spinal cord injury (SCI) peer support evaluation tool The purpose of this study was to develop and test a spinal cord injury (SCI) peer support evaluation tool that meets the needs of community-based SCI ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1936657424001067

Developing a mobile exercise program for individuals with ... This study aimed to identify factors contributing to the successful implementation of an app-based home exercise program for individuals with SCI

6. mhealth.jmir.org mhealth.jmir.org/2024/1/e53677

Self-Management Support Apps for Spinal Cord Injury This study aimed to identify and describe quantity, quality, focus, strengths, and weaknesses of self-management support apps for SCI available on major mobile ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10173031/

Mobile Health Self-management Support for Spinal Cord ... The objective of this systematic literature review was to identify mHealth SMS tools for SCI and summarize their characteristics and approaches to offering SMS.

8. health.utah.edu health.utah.edu/occupational-recreational-therapies/research/uspring/support-groove

Support Groove Cohabitate with romantic partner · Both partners must be willing to participate · One partner who had a spinal cord injury at least 3 months ago · Be at least 18 ...