Training to Enhance Adaptation and Management for Wheelchair Users (TEAMWheels)

Study Overview
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Brief Summary
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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.

Detailed Description
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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). Wheelchair Skills Test - Questionnaire (WST-Q). To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration. Wheelchair Outcome Measure (WhOM). The rehabilitation literature strongly suggests that intervention outcomes should include not only externally defined measures but also measures of user-identified activities of relevance and perceived satisfaction with performance. A 2008 review of wheelchair-specific outcomes found the WhOM was the only tool that included activities selected and weighted by the user and featured participation in social roles.Two published literature reviews identify the WhOM as the most client-centred and psychometrically robust tool among participation outcomes for wheelchair users. WhOM 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). Wheelchair Use Confidence Scale-(WheelCon-SF). Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 (not confident) to 10 (completely confident), providing a total mean score (0-10). The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95). The Short-Form 36 (SF-36) Health Survey Questionnaire is a measure of health status across the following domains: physical function, physical limitations, emotional limitations, pain, social function, energy, perceived health, and mental health. The literature identifies inherent wording bias of the mobility-related SF-36 test items, which presume ambulation as a norm so we opted to use the Enabled version that explicitly acknowledges the use of a mobility aid and replaces the words climbing and walking with going. Short Form-36E (Enabled) is specific to the study population of manual wheelchair users and will provide detailed and specific data related to HRQL. Objective Wheelchair Mobility. To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation. Program details TEAM Wheels is a 4-week, community-based, tailored program integrating eHealth and peer-led components to optimize learning while limiting the time demands of health care professionals. The eHealth component is a 10 computer tablet with a custom training application. The tablet mounts conveniently on the lap for in-chair training, enabling MWC users to learn and practice mobility skills in authentic contexts of home and community. The interactive application includes a structured curriculum with over 200 video clips featuring education, peer demonstration, and training activities. The peer-led component involves experienced MWC users with specialized training who can leverage their own experience and ability to relate as influential peers. The peer trainer conducts 3 virtual/teleconference (MS Teams) sessions with the participant, negotiating individualized goals, introducing wheelchair skills and management strategies, and providing an orientation to the eHealth home program. Peer trainers monitor eHealth training activity, which the tablet uploads to a secure website, intervening or modifying the program when required. Additional communication can be initiated between MWC user and peer trainer using a video messaging through MS Teams (on the computer tablet). The tablet is menu driven and interactive, using a touch-screen interface. A tablet offers considerable advantages over traditional paper/hand-out home programs. Training is provided in a multi-modal format with illustrations and videos, allowing detailed step-by-step guidance, close-ups, and demonstrations using age-appropriate older adult models. Practice activities can be clearly demonstrated (to ensure they are performed appropriately) and include imitative, function-based, and interactive game-related activities. Subjects can also contact their Peer-Trainer using the MS Teams (on the tablet); Trainers will review and respond within 48 hours. The tablet is housed in a rigid case with a simple strap that wraps around the participant's thighs. Subjects can secure the tablet on their lap and practice anywhere in their home or community, or place the tablet on another surface for viewing or video recording. Training activities are highlighted/checked off after completion, indicating to the subject they can advance to the next component. A Progress tab provides regular updates on the number of minutes practiced each week to reinforce adherence. The tablet will have Internet access for communication and data transfer/update capability, but the training program can operate in stand-alone mode as well.

Official Title
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Evaluation of a Peer-led eHealth Wheelchair Skills Training Program: Training to Enhance Adaptation and Management for Wheelchair Users

Conditions
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Mobility Limitation

Intervention / Treatment
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* Behavioral: TEAM Wheels


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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, Exclusion Criteria: have a health condition that might interfere with training (e.g., cancer; surgery) concurrently receiving any MWC skills training beyond that of typical practice

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: The treatment group receives the TEAM Wheels program over a 4-week period. Three virtual/teleconference (MS Teams) sessions will be arranged between the peer-trainer and participant, about 1 week apart. Peer trainers are experienced MWC users trained to deliver the TEAM Wheels program. After Session 1, participants engage in 4 weeks of eHealth home program training. They are asked to practice for 75-150 minutes per week, in 15-30 minute blocks, 1-2 times/day, 3-5 days/week. The control group receives no intervention over the 4-wk period (usual practice). Control group participants placed on the wait-list will receive the TEAM Wheels program following completion of the study. Any formal MWC training received during the wait-list period will be documented for potential post-hoc analysis as a confounding variable; research evidence and clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention-TEAM Wheels<br>The treatment group will receive the TEAM Wheels program over a 4-week period. Session 1 will be virtually delivered via MS Teams teleconference. The peer trainer is an experienced MWC user trained to deliver the TEAM Wheels program. At least 2 peers will be trained at each site to offer multiple trainer attributes; a male and female, one being at least 50 years old. Participants will pre-select a peer trainer from 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. After Session 1, participants engage in 4 weeks of eHealth home program training. They are instructed to practice for 75-150 minutes/week. Consistent with motor learning principles, we encourage training in 15-30 minute blocks 1-2 times/day, 3-5 days/week. The peer trainer arranges the remaining two virtual teleconference sessions with the participant, about 1 week apart. | Behavioral: TEAM Wheels<br>* A 1-month, peer-led, eHealth training program (TEAM Wheels) for individuals transitioning to manual wheelchair use to improve satisfaction with activity participation and related rehabilitation outcomes.<br>|
| No Intervention: Control-Wait List<br>The control group receives no specific intervention over the course of the 4-week period. This reflects usual practice/typical experience of a MWC user in their provincial context. Control group participants placed on the wait-list will receive the TEAM Wheels program following completion of the study (i.e. after post-treatment data collection). The site Research Coordinator/Assistant 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 Coordinator 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; research evidence and investigators' clinical experience confirm that in all 3 provinces formal training is not provided once MWC users are discharged from hospital. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) | 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). | Baseline | 
| Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) | 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). | Post-Treatment (Week 7) | 
| Satisfaction with Participation: Wheelchair Outcome Measure (WhOM) | 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). | 6-Month Follow-up (Week 31) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Wheelchair Skills Test - Questionnaire (WST-Q) | To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration. | Baseline | 
| Wheelchair Skills Test - Questionnaire (WST-Q) | To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration. | Post-Treatment (Week 7) | 
| Wheelchair Skills Test - Questionnaire (WST-Q) | To address environmental barriers, MWC users must learn specific mobility skills such as managing inclines, thresholds, and doorways. This is of considerable importance since training also involves learning to recognize risks and limitations. WST-Q evaluates 34 discrete skills; respondents rate their capacity (i.e. ability) with each skill as well as performance frequency. Capacity is rated as Yes (2), Yes with difficulty (1), or No (0); performance is rated as Always (2), Sometimes (1), or Never (0). Total skill Capacity (0-100%) and Performance (0-100%) scores are calculated. The WST has demonstrated excellent reliability for test-retest (ICC=0.90), intra-rater (ICC=0.96), and inter-rater (ICC=0.97) administration. | 6-Month Follow-up (Week 31) | 
| Wheelchair Use Confidence Scale-(WheelCon-SF) | Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 (not confident) to 10 (completely confident), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95). | Baseline | 
| Wheelchair Use Confidence Scale-(WheelCon-SF) | Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 (not confident) to 10 (completely confident), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95). | Post-Treatment (Week 7) | 
| Wheelchair Use Confidence Scale-(WheelCon-SF) | Self-efficacy has been identified as a key component in the performance of wheelchair mobility skills. Incorporating the principles of cognitive theory, including self-efficacy, can promote program adherence and skill acquisition. Preliminary research has suggested that standardized training can increase wheelchair confidence among older adults. WheelCon-SF is a self-report questionnaire with 21 statements related to confidence using a wheelchair in various activities and environments. Items are rated on a scale from 0 (not confident) to 10 (completely confident), providing a total mean score (0-10).27 The WheelCon-SF is more responsive than the original 65-item version; a recent study reported high test-retest reliability (ICC=0.98) and internal consistency (Cronbach's alpha = 0.95). | 6-Month Follow-up (Week 31) | 
| Short Form-36E (Enabled) | Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word go replaces walk and climb). SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health. | Baseline | 
| Short Form-36E (Enabled) | Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word go replaces walk and climb). SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health. | Post-Treatment (Week 7) | 
| Short Form-36E (Enabled) | Full title: Short Form 36 Health Survey Questionnaire (SF-36) (Enabled) 'Enabled' indicates wording is included above terms requiring adaptation for individuals requiring mobility assistive devices (the word go replaces walk and climb). SF-36E is a questionnaire specific to the study population of manual wheelchair users that provides detailed data related to HRQL specific to this population, which measures eight domains of health status: physical functioning (10 items); physical role limitations (four items); bodily pain (two items); general health perceptions (five items); energy/vitality (four items); social functioning (two items); emotional role limitations (three items) and mental health (five items). A scoring algorithm is used to convert the raw scores into the eight dimensions listed above. The scores are transformed to range from zero where the respondent has the worst possible health to 100 where the respondent is in the best possible health. | 6-Month Follow-up (Week 31) | 
| Objective Wheelchair Mobility | To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation. | Baseline | 
| Objective Wheelchair Mobility | To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation. | 2-weeks | 
| Objective Wheelchair Mobility | To triangulate measurement of improvement in mobility and community engagement, accelerometry data (ActigraphTM, Pensacola FL) will be used to objectively measure MWC activation over a 10-day period at baseline, post-treatment, and follow-up data collection points. The Actigraph is attached to a rear wheel on the MWC; a battery provides up to 14 days of passive data collection without impeding MWC operation. Data loggers have demonstrated valid and reliable measurement of MWC movement, with accuracy beyond 90%. A tri-axial accelerometer records acceleration forces during MWC use, downloadable as a .csv file. Algorithms developed by our team convert data into total and mean values of distance, speed, and 'bout' frequency (meaningful transitions between functional activities), parameters that reflect mobility patterns and activity of MWC users which we expect to change as a result of improvements in skill and participation. | 6-Month Follow-up |