Web-Based Training for Improving Skills

(SERT Trial)

Overseen By Lynn Worobey, PhD, DPT

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Michael Boninger

Disqualifiers: Pain, Active lower limb use, Pressure sores

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 aims to evaluate the effectiveness of a web-based training program in improving wheelchair transfer skills. Participants will either receive immediate access to the training or be placed on a waitlist to start after six months. The trial suits wheelchair users who can transfer independently, possibly using equipment like sliding boards, and primarily use seated pivot transfers. Participants should speak English as their primary language. The trial excludes individuals with pain that prevents transferring or recent pressure sores. As an unphased trial, this study provides a unique opportunity for participants to contribute to innovative research that could enhance daily living skills for wheelchair users.

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 this independent transfer training is safe?

Research has shown that the Independent Transfer Training program is easy for most people to use. Studies have found that this online training improves how people move from one place to another, such as from a wheelchair to a bed. Participants in those studies experienced better and safer movement. Importantly, no reports of serious side effects or harm have emerged from this training, indicating that most people handle it well.

The training not only improves skills but also maintains these improvements over time, meaning the benefits last. This indicates its safety and effectiveness. Those considering joining a clinical trial for this program can feel confident that it has been tested and found safe for users. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores web-based training to improve skills, particularly focusing on independent transfer techniques for individuals with mobility challenges. Unlike traditional in-person therapy sessions, this training offers online accessibility, allowing participants to engage with the program at their own pace and convenience. This could potentially broaden access to essential skills training, especially for those with limited mobility or geographical constraints. Additionally, the trial is examining both immediate and delayed training effects, which might provide insights into the optimal timing and structure of therapy for long-term benefits.

What evidence suggests that this independent transfer training is effective for improving skills?

Studies have shown that online transfer training effectively improves transfer performance, with benefits lasting up to a month after training. Research comparing this online method with traditional in-person training found both equally effective. Thus, online training works as well as in-person training. In this trial, participants will engage in the Independent Transfer Training program through various approaches, such as immediate training with or without follow-up, or randomized training. These findings suggest that the Independent Transfer Training program can effectively help people learn and improve their skills through an online platform. ^{1 6 7 8 9}

Who Is on the Research Team?

Michael L Boninger, MD

Principal Investigator

University of Pittsburgh

Are You a Good Fit for This Trial?

This trial is for individuals who primarily use a wheelchair (over 40 hours per week) and can transfer themselves independently, possibly with the help of equipment like sliding boards. Participants must speak English as their primary language. Those with pain that prohibits transfers, active use of lower limb muscles during transfers, or recent pressure sores are not eligible.

Inclusion Criteria

I primarily speak English.

I use a wheelchair for most of my daily movements.

I can move myself with or without help from equipment.

Exclusion Criteria

My pain stops me from moving from one place to another.

I can use my leg muscles to move from one place to another.

I have had pressure sores in the last 3 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants complete baseline questionnaires before training

1 week

Online

Training

Participants receive the independent transfer training program

1 hour

Online

Immediate Post-Training Assessment

Participants complete questionnaires to assess the effectiveness of the training

1 week

Online

Follow-up

Participants are monitored for effectiveness and satisfaction at 1 month and 6 months post-training

6 months

Online

What Are the Treatments Tested in This Trial?

Interventions

• Independent Transfer Training

Trial Overview The study aims to evaluate the effectiveness of an independent transfer training program delivered through a web-based platform. It seeks to identify ways to enhance the success rate of participants in mastering online remote transfer training techniques.

How Is the Trial Designed?

Group I: Randomized Training Experimental Treatment 1 Intervention

Individuals may decide to participate in the research study and agree to be randomized. These individuals will be immediately randomized into an immediate or a wait list control group. The immediate will receive the independent transfer training program after completing the baseline questionnaires. The wait list control group will wait approximately 6 months before receiving the independent transfer training program.

Group II: Immediate Training (with follow up) Experimental Treatment 1 Intervention

Individuals may decide to participate in the research study, but do not want to be randomized. After consent is obtained, these individuals will be directed immediately to the baseline questionnaires (see above) before and after the independent transfer training. Participants may also be asked to complete a user satisfaction survey.

Group III: Immediate Training (no follow up) Experimental Treatment 1 Intervention

Individuals may decide to participate in the research study training program, but not in any follow up questionnaires. This group will have immediate access to the independent transfer training materials. They will complete data collection measures embedded in the transfer training program, including demographics, Online Learning Readiness Scale (OLRS), Moorong Self Efficacy Scale (MSES), Patient Reported Outcome Measurement Information System (PROMIS), Transfer Assessment Instrument Questionnaire (TAI-Q), and the Wheelchair User Shoulder Pain Index (WUSPI).

Who Is Running the Clinical Trial?

Michael Boninger

Lead Sponsor

Trials

3

Recruited

230+

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Department of Health and Human Services

Collaborator

Trials

240

Recruited

944,000+

Published Research Related to This Trial

A study involving 31 health professionals revealed significant gaps in knowledge and fear of punishment as major barriers to effectively reporting adverse events in a teaching hospital.

Improving communication and educational practices between leaders and healthcare professionals is essential to enhance the reporting of adverse events, which is crucial for patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The practice of reporting adverse events in a teaching hospital. Siman, AG., Cunha, SGS., Brito, MJM.[2019]

The web-based adverse event tracking system (eAETS) has effectively supported 175 clinical protocols over four years, capturing 2,440 adverse event reports, including minor symptoms that could indicate serious issues.

Out of the reported AEs, 1,053 did not align with the initial risk profiles, leading to corrective recommendations in 13% of the protocols, highlighting the system's role in enhancing subject safety by identifying unanticipated patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of minor adverse event tracking on subject safety: a web-based system. Shenvi, NV., Gebhart, SS.[2009]

A systematic review of 130 studies on muscle strengthening training (MST) in youth revealed that only 33.8% reported on adverse events (AEs), highlighting a significant gap in safety monitoring during these interventions.

Among the studies that did report AEs, 40.1% documented at least one adverse event, with over half of the reported events (59.1%) linked directly to the training or testing, indicating a need for better definitions and reporting practices in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of Adverse Events in Muscle Strengthening Interventions in Youth: A Systematic Review. Mack, DE., Anzovino, D., Sanderson, M., et al.[2023]

A 22-month study showed that trainee-led monthly conferences significantly increased the reporting of adverse events by medical trainees, with submissions rising from an average of 6.7 to 14.1 reports per month (P < .001).

These conferences not only improved reporting rates but also empowered trainees to identify system vulnerabilities and propose meaningful solutions, enhancing overall patient safety in the hospital setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Trainee Reporting of Adverse Events With Monthly Trainee-Directed Review of Adverse Events. Smith, A., Hatoun, J., Moses, J.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34090854/

Effectiveness of a Web-Based Direct-to-User Transfer Training ... A web-based, direct-to-user transfer training program in improving transfer quality and maintaining improvements for up to 1 month after training.

2. archives-pmr.org archives-pmr.org/article/S0003-9993(17)30495-1/fulltext

Investigating the Efficacy of Web-Based Transfer Training ... To determine the efficacy of a web-based transfer training module at improving transfer technique across 3 groups: web-based training, in-person training.

3. tandfonline.com tandfonline.com/doi/full/10.1080/08923647.2022.2029090

Full article: In-Person or Virtual Training?: Comparing the ... Studies comparing in-person and asynchronous distance community-based trainings have been reported to have no significant difference in outcomes ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999317304951

Investigating the Efficacy of Web-Based Transfer Training ... To determine the efficacy of a web-based transfer training module at improving transfer technique across 3 groups: web-based training, in-person training ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8642492/

Effectiveness of A Web-Based Direct-to-User Transfer ... To determine the effectiveness of a web-based, direct-to-user transfer training program in improving transfer quality and maintaining improvements for up to ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11527472/

Effectiveness of active learning-based transfer movement ... The study found that active learning-based transfer training improved caregiver assessment skills, with effects persisting after one month, ...

7. sciencedirect.com sciencedirect.com/science/article/am/pii/S0003999321004330

Effectiveness of a Web-Based Direct-to-User Transfer ... The web-based training significantly improved transfer quality for the immediate intervention group, and also showed improvements for the control group, with ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0925753525000955

Comparing training delivery methods: Impact on learning ... This study assessed the effectiveness of five safety training delivery methods—pre-recorded video, lecture, interactive lecture, flipped lecture (pre-recorded ...

9. mdpi.com mdpi.com/2227-9032/13/2/133

From Online Learning to Clinical Practice: An Investigation ... The present study adopted an extended TPB model to investigate the potential psychosocial factors affecting the intention to transfer knowledge and skills ...