Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 54
- 试验地点
- 6
- 主要终点
- Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)
研究概览
简要总结
The purpose of this study is to evaluate the effect of a 1-month, peer-led eHealth training program (TEAM Wheels) on satisfaction with activity participation and related rehabilitation outcomes among individuals transitioning to manual wheelchair use, compared with current wheelchair training practice. The primary objectives include: 1. Measuring the effect of TEAM Wheels on satisfaction with participation in important activities of life compared to current practice; 2. Measuring retention of participation benefits at 6-months post treatment. Secondary Objectives relate to additional rehabilitation Outcomes and include: 1. Comparing the effect of TEAM Wheels to current practice on wheelchair skills capacity and performance; wheelchair-specific self-efficacy; health-related quality of life; and objective measurement of wheelchair mobility. 2. Measuring retention of rehabilitation outcome benefits at 6-months post treatment.
详细描述
This study will use a three-site (Winnipeg, Vancouver, and Quebec City) randomized controlled trial to compare differences in current wheelchair training practice and a 1-month, peer-led (virtual due to SARS-CoV-2; COVID-19) eHealth training program (TEAM Wheels). Subjects will randomly be assigned to the TEAM Wheels or control group using a 1:1 allocation ratio between groups. To support balance between groups and masking of assignment, our statistician will create a computerized randomization process with undisclosed block size. Once subjects are enrolled, baseline data will be collected and entered into a secure database. A site coordinator or assistant will then obtain the participant's group assignment and coordinate the first in-person peer trainer session. For treatment group assignments this will occur as soon as it is practical and for control group assignments this will be scheduled after blinded post-treatment data collection is complete. To address bias, subjects will be instructed not to discuss their program.
The treatment group will receive the TEAM Wheels program over a 4-week period. An initial meeting (Session 1) will be arranged via teleconference (MS Teams). The peer trainer is an experienced Manual Wheelchair (MWC) user trained to deliver the TEAM Wheels program. At least 2 peers will be hired and trained at each site to offer multiple trainer attributes. We will intentionally include a male and female, one being at least 50 years of age. Participants will pre-select a peer trainer based on a biosketch to optimize training effect (e.g., preference for age, sex factors); comparability in age has been identified as preferential among older adults and influential to self-efficacy. Following Session 1, participants engage in 4 weeks of training with the eHealth home program. They are instructed to practice for 75 to 150 minutes per week. Consistent with motor learning principles, we encourage training in 15-30 minute blocks 1-2 times per day, 3-5 days per week. The peer trainer will arrange with the participant the remaining two virtual sessions, approximately one week apart.
Control Group. The control group receives no specific intervention over the course of the 4-week period. This reflects "usual practice" or the typical experience of a MWC user in their provincial context. Control group participants placed on the wait-list will receive the TEAM Wheels program, as described, following completion of the study (i.e. after post-treatment data collection). The site Research Coordinator will make telephone or email contact with control group participants at the end of weeks 2 and 4 during the study period to deter attrition/drop-out. When contact is made at week 4, the Research Coordinatort will schedule an appointment for post-treatment data collection (week 7). Any formal MWC training received during the wait-list period will be documented for potential post-hoc analysis as a confounding variable; however, research evidence and the investigators' clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital.
Assessments. The outcome measures will be collected at baseline (pre-randomization) and post-intervention. A Research Assistant/Coordinator at each site will contact the participant via MS Teams videoconference at baseline and subsequent data collection points to administer the outcome measures. Participants will be shown a video to help them apply an Actigraph device (i.e. small battery-operated accelerometer) to the participant's wheelchair spokes and after 2 weeks will either retrieve it or provide a self-addressed stamped envelope for the participant to return via post. Post-treatment data will be collected at week 7 to incorporate a 2-week window for consolidation of learning following the 4-week intervention. Follow-up (retention) data will be collected from treatment group participants 6 months later (week 31).
Outcome measures. At baseline, descriptive characteristics including age, sex, gender, marital status, the highest level of education, primary diagnoses related to MWC use, Wheel diameter, and length of time using the MWC will be collected. Five outcome measures will be administered at baseline, post-treatment, and 6-month follow-up (for treatment group participants).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Neither the investigators nor the biostatistician/outcomes assessor will know the intervention arm to which study participants have been assigned. A unique study ID will be assigned to each study participant and as well as a unique code to distinguish which intervention arm to which each participant is randomized.
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •use a MWC (even part time)
- •living in the community
- •have the ability to propel with both arms
- •have sufficient language abilities to engage with the training material in English,
排除标准
- •have a health condition that might interfere with training (e.g., cancer; surgery)
- •concurrently receiving any MWC skills training beyond that of typical practice
结局指标
主要结局
Satisfaction with Participation: Wheelchair Outcome Measure (WhOM)
时间窗: 6-Month Follow-up (Week 31)
WhOM has been found to be the only tool that includes activities selected and weighted by the user and featured participation in social roles. WhOM has been identified as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. It is administered as a semi-structured interview. Respondents identify 10 activities (5 performed inside and 5 performed outside of the home), rating their satisfaction with performance on an 11-point scale (0-10) for each activity. The WhOM demonstrates good reliability (Test-retest ICC = 0.83-0.88; Inter-rater ICC = 0.90-0.91) and validity (correlations with LIFE-H: rs = 0.3-0.5) in use among individuals with spinal cord injury and older adults (Test-retest ICC = 0.77-1.00; correlation with QUEST rs = 0.36 -0.45).
次要结局
- Short Form-36E (Enabled)(6-Month Follow-up (Week 31))
- Objective Wheelchair Mobility(6-Month Follow-up)
- Wheelchair Skills Test - Questionnaire (WST-Q)(6-Month Follow-up (Week 31))
- Wheelchair Use Confidence Scale-(WheelCon-SF)(6-Month Follow-up (Week 31))
