Clinical trial NCT03164278: Effectiveness of Web-Based Training (SERT)
Official title: Studying the Effectiveness of Remote Training
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Remote Transfer Training Program
Keywords: Wheelchair
Biomechanics
Transfer
Participation
Training
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
Collaborators: name: Department of Health and Human Services
First posted: 2017-05-23
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This is a randomized single blind study.
Primary purpose: SUPPORTIVE_CARE

Brief summary: The objective of this research study is to assess the effectiveness of an independent transfer training program (ITTP), and to determine methods which may increase overall success of an online training program.

Detailed description: Up to 200 individuals will be recruited for this research study. Investigators will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), have the ability to transfer independently (may use equipment like sliding boards), use a seated pivot to transfer, and speak English as a primary a language. This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will be randomized into three groups; one group that will receive transfer training immediately with no follow up, one group that will receive the transfer training immediately with 1 month and 6 month follow up, and one group that will receive the transfer training after 6 months. The transfer training program itself will take approximately 1 hour to complete.

After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the transfer training program.

Participants in the third group (a wait-list control group) will complete the baseline questionnaires and be contacted one month later to complete a transfer assessment instrument questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the transfer training.

After completing the transfer training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote transfer training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires.

Eligibility criteria: Inclusion Criteria:

1. Utilize a wheelchair for the majority of mobility (over 40 hours per week).
2. Ability to transfer independently (may use equipment like sliding boards).
3. Use of seated pivot transfer
4. Speak English as a primary a language

Exclusion Criteria:

1. Pain prohibiting transfers
2. Active use of the lower limb muscles during transfers
3. Current or recent history (last 3 months) of pressure sores

Primary outcomes:
measure: Change in Transfer Assessment Instrument Questionnaires (TAI-Q)
timeFrame: This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.
Secondary outcomes:
measure: Change in Wheelchair Users Shoulder Pain Index (WUSPI)
timeFrame: This measure is collected pre- training, as well as at 6 month follow up.
measure: Change in Patient Reported Outcomes Measurement Information System: Physical Function with Mobility Aid
timeFrame: This measure is collected pre-training and at the 6 month follow up.
measure: Change in Patient Reported Outcomes Measurement Information System: Satisfaction with Social Roles & Activities
timeFrame: This measure is collected pre-training and at the 6 month follow up.
measure: Change in Patient Reported Outcomes Measurement Information System: Ability to Participate in Social Roles and Activities
timeFrame: This measure is collected pre-training and at the 6 month follow up.
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Michael Boninger, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rigot SK, DiGiovine KM, Boninger ML, Hibbs R, Smith I, Worobey LA. Effectiveness of a Web-Based Direct-to-User Transfer Training Program: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2022 Apr;103(4):807-815.e1. doi: 10.1016/j.apmr.2021.05.007. Epub 2021 Jun 4.