Remote Maintenance Training ProgramNCT03909061
Wheelchair Maintenance Training Program
A study testing Wheelchair Maintenance Training in people with Remote Maintenance Training Program, run by University of Pittsburgh at 1 site in United States.
Trial summary
The objective of this research study is to assess the effectiveness of a remote wheelchair maintenance training program, and to determine methods which may increase overall success of an online training program. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Remote Maintenance Training Program
- What is being tested?
- Wheelchair Maintenance Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 187 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2019to 10 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Have a traumatic spinal cord injury
- Use a wheelchair as a primary means of mobility (>40 hours per week)
Who cannot join
- English is not a primary language
- Primary residence is not in the United States
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pittsburgh
Pittsburgh, Pennsylvania, 15260
About this study
Official title: Effectiveness of a Remote Wheelchair Maintenance Training Program
The objective of this research study is to assess the effectiveness of a remote wheelchair maintenance training program, and to determine methods which may increase overall success of an online training program.
Read the detailed description
Up to 100 individuals will be recruited for this research study. We will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), and have a traumatic spinal cord injury (SCI). This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will select to participate in one of three groups; one group that will receive maintenance training immediately with no follow up, one group that will receive the maintenance training immediately with 1 month and 6 month follow up, and one group that will be randomized to either receive the maintenance training immediately or after 6 months. The maintenance training program itself will take approximately 1-2 hours to complete.
After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the maintenance 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 wheelchair maintenance assessment questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the wheelchair maintenance training.
After completing the maintenance training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires. Participants may be compensated for their time.
- Conditions
- Remote Maintenance Training Program
- Being tested
- Wheelchair Maintenance Training
- Keywords
- Wheelchair, Participation, Training, Maintenance, Breakdown
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wheelchair Maintenance TrainingBehavioural
Wheelchair Maintenance Training Program: WMTP training consists of three parts. It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair. Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program. Participants will also be informed when a repair requires professional assistance and where such assistance may be found.
| Study group | Role | What they receive |
|---|---|---|
| Immediate Training (no follow up) | Experimental | 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 maintenance training materials. They will complete data collection measures embedded in the maintenance training program, including demographics, Online Learning Readiness Scale (OLRS), Moorong Self Efficacy Scale (MSES), Patient Reported Outcome Measurement Information System (PROMIS), Assistive Technology Module Questionnaire (ATM-Q), and the Wheelchair Maintenance Training Questionnaire (WMT-Q). Receives: Behavioral: Wheelchair Maintenance Training |
| Immediate Training (with follow up) | Experimental | 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 wheelchair maintenance training. Participants may also be asked to complete a user satisfaction survey. Receives: Behavioral: Wheelchair Maintenance Training |
| Randomized Training | Experimental | 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 wheelchair maintenance training program after completing the baseline questionnaires. The wait list control group will wait approximately 6 months before receiving the independent maintenance training program. Receives: Behavioral: Wheelchair Maintenance Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Wheelchair Maintenance Training Questionnaire (WMT-Q)
The WMT-Q has three sub scales which measure of an individual's knowledge of maintenance (knowledge), their or their caregiver's ability to complete maintenance (capacity), and the frequency at which they or their caregiver perform it (performance). Each subscale ranges from 0-100 with larger numbers indicating greater proficiency.
Measured: 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 (1)
Change in Assistive Technology Module Questionnaire (ATM-Q)
This outcome measure collects information on the number of repairs an individual's wheelchair required as well as the incidence of subsequent consequences from the repair - stranded, injured, missed work or school, or missed a medical appointment.
Measured: This measure is collected at baseline, pre- training, and at the 6 month follow up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start15 Mar 2019
- Primary completion10 Aug 2023
- Study completion10 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Remote Maintenance Training ProgramStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This is a randomized single blind study.
- Masking
- None (open label)
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health and Human Services
- Responsible party
- Principal investigator, Lynn Worobey, University of Pittsburgh
- Investigators
- Lynn Worobey, PhD, DPT, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03909061
- Sponsor's protocol ID
- STUDY18100047
- Other IDs
- 90SI5014-01-00
- Status last verified
- Nov 2024
- First submitted
- 7 Apr 2019
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified data may be shared with other investigators.
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Remote Wheelchair Maintenance Training Program
- ClinicalTrials.gov ID
- NCT03909061
- Acronym / sponsor ID
- STUDY18100047
- Conditions
- Remote Maintenance Training Program
- Keywords
- Wheelchair, Participation, Training, Maintenance, Breakdown
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 187 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- Department of Health and Human Services
- Study start
- 15 Mar 2019 (actual)
- Primary completion
- 10 Aug 2023 (actual)
- Study completion
- 10 Aug 2023 (actual)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this research study is to assess the effectiveness of a remote wheelchair maintenance training program, and to determine methods which may increase overall success of an online training program.
Detailed description
Up to 100 individuals will be recruited for this research study. We will recruit individuals who use a wheelchair for the majority of their mobility (over 40 hours per week), and have a traumatic spinal cord injury (SCI). This study will be accessed entirely online and participation is expected to last approximately one year. Subjects will select to participate in one of three groups; one group that will receive maintenance training immediately with no follow up, one group that will receive the maintenance training immediately with 1 month and 6 month follow up, and one group that will be randomized to either receive the maintenance training immediately or after 6 months. The maintenance training program itself will take approximately 1-2 hours to complete.
After obtaining informed consent, participants in the first two groups will complete baseline questionnaires. They will then receive the maintenance 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 wheelchair maintenance assessment questionnaire. They will then wait 5 months. After this period, participants will complete the baseline questionnaires a second time, and then receive the wheelchair maintenance training.
After completing the maintenance training, all groups will be contacted immediately post training to complete additional questionnaires to assess the effectiveness of the remote training program. Participants in the 2nd and 3rd group will be contacted 1 month and 6 months post-training to complete additional questionnaires. Participants may be compensated for their time.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- This is a randomized single blind study.
| Arm | Type | Receives |
|---|---|---|
| Immediate Training (no follow up) | Experimental | Behavioral: Wheelchair Maintenance TrainingIndividuals 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 maintenance training materials. They will complete data collection measures embedded in the maintenance training program, including demographics, Online Learning Readiness Scale (OLRS), Moorong Self Efficacy Scale (MSES), Patient Reported Outcome Measurement Information System (PROMIS), Assistive Technology Module Questionnaire (ATM-Q), and the Wheelchair Maintenance Training Questionnaire (WMT-Q). |
| Immediate Training (with follow up) | Experimental | Behavioral: Wheelchair Maintenance TrainingIndividuals 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 wheelchair maintenance training. Participants may also be asked to complete a user satisfaction survey. |
| Randomized Training | Experimental | Behavioral: Wheelchair Maintenance TrainingIndividuals 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 wheelchair maintenance training program after completing the baseline questionnaires. The wait list control group will wait approximately 6 months before receiving the independent maintenance training program. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Have a traumatic spinal cord injury
- Use a wheelchair as a primary means of mobility (>40 hours per week)
Key exclusion criteria (2 listed)
- English is not a primary language
- Primary residence is not in the United States
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Wheelchair Maintenance TrainingWheelchair Maintenance Training Program: WMTP training consists of three parts. It starts with an overview of basic wheelchair maintenance items, continues with the second section discussing how to inspect the parts of a wheelchair and finishes with the third section discussing how to perform wheelchair maintenance on a wheelchair. Throughout the course, there are videos and pictures demonstrating the activities discussed in the training program. Participants will also be informed when a repair requires professional assistance and where such assistance may be found. | Behavioural | Immediate Training (no follow up), Immediate Training (with follow up), Randomized Training |
Primary outcome
Change in Wheelchair Maintenance Training Questionnaire (WMT-Q)
Time frame: This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.
The WMT-Q has three sub scales which measure of an individual's knowledge of maintenance (knowledge), their or their caregiver's ability to complete maintenance (capacity), and the frequency at which they or their caregiver perform it (performance). Each subscale ranges from 0-100 with larger numbers indicating greater proficiency.
1 secondary outcome
Change in Assistive Technology Module Questionnaire (ATM-Q)
Time frame: This measure is collected at baseline, pre- training, and at the 6 month follow up.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Individual participant dataSharing planned: Yes. De-identified data may be shared with other investigators.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lynn Worobey, PhD, DPT principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wheelchair Maintenance Training in people with Remote Maintenance Training Program, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Wheelchair Maintenance Training Questionnaire (WMT-Q) (time frame: This measure is collected at baseline, pre- training, during the training, as well as at the 1 month and 6 month follow ups.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Nov 2024.