Development, Acceptability, and Usability of a Virtual Intervention for Vertebral Fractures

Abstract

Objective

This project aimed to develop a virtual intervention for vertebral fractures (VIVA) to implement the international recommendations for the nonpharmacological management of osteoporotic vertebral fractures and to test its acceptability and usability.

Methods

VIVA was developed in accordance with integrated knowledge translation principles and was informed by the Behavioral Change Wheel, the Theoretical Domains Framework, and the affordability, practicability, effectiveness and cost-effectiveness, acceptability, side effects/safety, and equity (APEASE) criteria. The development of the prototype of VIVA involved 3 steps: understanding target behaviors, identifying intervention options, and identifying content and implementation options. The VIVA prototype was delivered to 9 participants to assess its acceptability and usability.

Results

VIVA includes 7 1-on-1 virtual sessions delivered by a physical therapist over 5 weeks. Each session lasts 45 minutes and is divided in 3 parts: education, training, and behavioral support/goal setting. Four main themes emerged from the acceptability evaluation: perceived improvements in pain, increased self-confidence, satisfaction with 1-on-1 sessions and resources, and ease of use. All of the participants believed that VIVA was very useful and were very satisfied with the 1-on-1 sessions. Four participants found the information received very easy to practice, 4 found it easy to practice, and 1 found it somewhat difficult to practice. Five participants were satisfied with the supporting resources, and 4 were very satisfied. Potential for statistically significant improvements was observed in participants’ ability to make concrete plans about when, how, where, and how often to exercise.

Conclusion

VIVA was acceptable and usable to the participants, who perceived improvements in pain and self-confidence.

Impact

The virtual implementation of the recommendations for the nonpharmacological management of vertebral fractures showed high acceptability and usability. Future trials will implement the recommendations on a larger scale to evaluate their effectiveness.

Introduction

Osteoporotic vertebral fracture (VF) is the most common type of fracture in people with osteoporosis.^1–3 One in 5 women with an incident VF will experience another one within 1 year,⁴ and the risk of death is 9 times higher after VF.⁵ VFs may cause pain, loss of height, and progressive thoracic kyphosis, which can impair physical function, pulmonary function, and appetite.^1,6,7 External loads, like groceries, laundry, or carrying weights, increase the forces on vertebrae, and increase fracture risk,⁸ but VFs often occur during twisting movements or forward bending with no external loads. Exercise may represent a strategy to improve physical functioning and manage pain after VFs, but further evidence is needed before making final conclusions on the real-world effectiveness of exercise in this patient population.^9–11

The Medical Research Council has recommended that the development and evaluation of complex interventions be based on theory, tailored to the local context (according to the integrated knowledge translation approach),¹² informed by systematic evidence, and built on previous smaller-scale studies.¹³ Interventions that are developed using behavior change theories lead to larger effects as compared to those that are not theory-based.^14,15 The Patient-Centred Outcomes Research Institute identifies “community stakeholders” as patients, caregivers, patient advocates, and members of the general public,¹⁶ and the benefits from the involvement of community stakeholders at every stage of the research process are widely recognized.¹² The need to overcome barriers such as transportation, as well as the COVID-19 pandemic, which resulted in delayed access to health care services,¹⁷ contributed to the diffusion of virtually delivered interventions, which have proven to be acceptable to people with different conditions.^18–23 The evidence on the benefits of the nonpharmacological and nonsurgical management of VFs is scarce. We performed a Cochrane review on the effects of exercise after VFs, which showed that exercise probably improves physical functioning, but could not provide definitive conclusions on incident fractures, falls, or adverse events.²⁴ Five more recent exercise trials that recruited people with and without VFs showed improvements in patient-reported outcomes of health-related quality of life and physical functioning.^25–29 Furthermore, we performed systematic searches to retrieve information on the nonpharmacological and nonsurgical management of individuals at high risk of fracture, which highlighted an important knowledge gap in nonsurgical and nonpharmacological options to prevent and manage VFs. A previous consensus process³⁰ that provided recommendations for people with osteoporosis recommended focusing on postural alignment and proper body mechanics and providing education on strategies to control pain, such as sitting in erect alignment with appropriate lumbar spine support, or spending time in supine to encourage spinal extension, and stretching of the pectoral and front shoulder muscles. Our group led an international consensus process on the nonpharmacological management of VFs,³¹ which provided recommendations on pain management, nutrition, safe movement strategies, and exercise, that should be started as soon as tolerated to improve back extensor endurance, spinal mobility, physical functioning, and balance. However, the efficacy of these recommendations for improving outcomes relevant to people with VFs, and the effectiveness of their implementation in the daily life have not been investigated yet. Therefore, we codeveloped a virtual intervention for vertebral fractures (VIVAs) with patients and health care providers. VIVA is a virtually delivered education and training program that represents the first step in the implementation of the recommendations for the management of VFs. We delivered it to a small sample of people with VFs to test its acceptability and usability. We hypothesized high acceptability and usability scores and aimed to observe the potential for improvement in the secondary outcomes of quality of life and exercise self-efficacy. Herein, we report findings from the development process, and the acceptability and usability study.

Methods

Development of VIVA

In accordance with integrated knowledge translation principles,¹² we established a steering committee that included: physicians and other health care professionals in geriatrics, internal medicine, physical therapy, and dietetics; researchers with expertise in rehabilitation, pain, nutrition, malnutrition, osteoporosis, postfracture care, and knowledge translation; patients and stakeholders. We used the Behavioral Change Wheel³² and the Theoretical Domains Framework³³ to guide the development of the intervention. We adopted a 3-stage process to design our intervention: understand the behavior, identify intervention options, and identify content and implementation options. The affordability, practicability, effectiveness and cost-effectiveness, acceptability, side effects/safety, and equity (APEASE)³² criteria were used to inform the design and the acceptability and usability evaluation of the intervention. The prototype of VIVA, including intervention contents and modality of delivery, has been reported according to the Template for Intervention Description and Replication Checklist.

Stage 1: Understand the Behavior

We previously conducted focus groups and individual interviews with people with osteoporosis³⁴ and VFs,³⁵ which revealed the absence of patient-centered strategies for managing pain and improving physical functioning after VF. Further quantitative and qualitative evidence^34–38 reported acute or chronic pain, and living with fear of falling, refracturing, or doing movements that can exacerbate pain, transportation (public transit not available, or available at times that do not match exercise schedule), and winter weather conditions as barriers that interfere with activities of daily living and exercise, and healthy eating in people with osteoporosis. Therefore, our steering committee identified 4 behaviors that might have a positive effect on pain, physical functioning, and fear: adopting safe movement techniques during activities of daily living, performing pain management strategies daily, exercising at least 3 times per week, and following tips for optimal nutrition daily.

Stage 2: Identify Intervention Options

Capability, opportunity, and motivation represent the source of behaviors, as for a behavior to occur there must be capability of the person do it, the opportunity for the behavior to happen, and sufficient motivation (Tab. 1).³² We identified communication and service provision as the most appropriate policy categories for the delivery of VIVA. We designed VIVA to be delivered by a trained physical therapist over Zoom (Zoom Video Communications, Inc, San Jose, CA, USA; https://www.zoom.us), to minimize transportation barriers and maximize retention and adherence. We created 1-page information sheets on pain management, safe movement strategies, exercise, and tips for an optimal nutrition, and provided drafts to 2 individuals with VF and 3 physical therapists with expertise in VFs to gather their feedback and perspectives on areas for improvement. One-page information sheets, photos, and videos of exercises, safe movement and pain management techniques, weekly exercise prescriptions, and the diary to track the weekly adherence to the program are delivered to the participants throughout the intervention in a personal online portal (Physiotec; Physiotec, Saint-Hubert, Quebec, Canada; https://physiotec.ca/ca/en/).

Stage 3: Identify Content and Implementation Options

The goal of VIVA is to implement the recommendations for the nonpharmacological management of VFs.³¹ Two authors (M.P., L.M.G.) selected the behavior change techniques and drafted an outline of the intervention, which was finalized after 1 videoconference and 2 rounds of revisions via email by the team members. The final prototype of VIVA was then reviewed for content, acceptability, equity, practicability, and safety by 2 individuals with VF, who provided feedback in a 120-minute meeting, and 3 physical therapists, who provided feedback during 3 individual 45- to 60-minute meetings.

Acceptability and Usability Evaluation

We delivered the VIVA prototype to 9 participants; 5 participants are suggested to capture 85% of usability issues,³⁹ and we wanted to account for potential attrition. Inclusion criteria were as follows: 50 years old or older, pain due to 1 or more VFs, and access to the internet and computer or tablet with a camera and microphone. Potential participants were excluded if they had contraindications to exercise according to the Get Active Questionnaire⁴⁰ from the Canadian Society for Exercise Physiology (https://csep.ca/2021/01/20/pre-screening-for-physical-activity/) or if they had used oral glucocorticoids in the past 12 months for ≥3 months at a prednisone-equivalent dose of ≥7.5 mg/day. This study received ethics approval from the University of Waterloo Research Ethics Board (ORE #43705).

Acceptability

We operationalized acceptability as participants’ satisfaction with treatment, which involves a comprehensive appraisal of intervention components, mode of delivery, and experienced benefits.^41,42 We performed semistructured interviews with each participant at the end of the intervention and performed thematic^43,44 and content⁴⁵ analyses conducted at the semantic level. The qualitative analysis was performed using NVivo version 12 (QSR International Pty Ltd, Doncaster, Victoria, Australia) and involved the following 6 steps: audio-recording and transcribing the interviews verbatim; 2 authors (M.P., N.T.) familiarizing themselves with the interviews; M.P. and N.T. coding the first 2 transcripts and developing an initial analytical framework; M.P. and N.T. coding a subsequent 2 transcripts to form the final analytical framework; M.P. and N.T. coding each of the remaining transcripts using the final analytical framework (new codes were discussed and incorporated); and interpreting the data collected. We conceptualized our categories in a thematic map and compared our themes to the data within the codes to explore if a pattern existed. We performed a content analysis (Hsieh and Shannon⁴⁵) to identify the VIVA components that were better accepted by the participants and those that may need some revisions before implementing VIVA on a larger scale.

Usability

We operationalized usability as perceived usefulness, ease of practice, satisfaction with 1-on1 sessions, satisfaction with supporting resources. We evaluated the usability of VIVA by mean of an online survey (Qualtrics; Qualtrics, Seattle, WA, USA; https://www.qualtrics.com/) consisting of 4 statements, and the participants had to select the category that best represented their perception of VIVA using a 5-point Likert-type scale: the VIVA was useful (1 = not at all useful, 2 = somewhat useful, 3 = undecided, 4 = useful, and 5 = very useful); the information received was easy to practice during the week (1 = difficult, 2 = somewhat difficult, 3 = undecided, 4 = easy, and 5 = very easy); I was satisfied with the 1-on-1 sessions (1 = not at all satisfied, 2 = somewhat satisfied, 3 = undecided, 4 = satisfied, and 5 = very satisfied); and I was satisfied with the supporting resources (eg, 1-page information sheets, videos) (1 = not at all satisfied, 2 = somewhat satisfied, 3 = undecided, 4 = satisfied, and 5 = very satisfied).

Secondary Outcomes

The 5-level version of the EuroQol-5D (EQ-5D-5L)⁴⁶ was administered to calculate a health state utility value based on mobility, ability to self-care, ability to perform usual activities, pain/discomfort, and anxiety/depression. The EQ-5D-5L health utilities for the Canadian population range from −0.148 for the worst EQ-5D-5L states to 0.949 for the best.⁴⁷ We administered the Exercise Self-Efficacy Questionnaire, a questionnaire informed by the Health Action Process Approach^48–51; it includes 2 questions with 6 and 5 statements each. For each statement, the participants selected the category that best aligned with how they felt using a 5-point categorical scale: 1 = not at all true, 2 = barely true, 3 = unsure, 4 = mostly true, and 5 = exactly true. The Exercise Self-Efficacy Questionnaire has been reported to have very good internal consistency (Cronbach α = 0.82).^48,52,53 The self-reported questionnaires were administered online using Qualtrics. Participants were asked to track their adherence using a calendar in the online portal in Physiotec. Adherence was defined as the number of days when participants performed the unsupervised home program (100% adherence = unsupervised home program performed 28 times). We set the criterion for success at 60% of adherence to the daily home program.⁵⁴

Intervention Delivery Fidelity

To enhance the fidelity of the delivery of the intervention,⁵⁵ we created a study manual outlining the principles, the intervention components, the therapeutic goals based on the time after the fracture, and the modes of delivery of VIVA that the physical therapist was asked to follow. Two virtual “training meetings” between the physical therapist and the lead researcher (M.P.) were scheduled before the beginning of the intervention. We operationalized fidelity as adherence, differentiation, and competence of the physical therapist.⁵⁵ Adherence refers to whether the intervention was delivered as intended.⁵⁶ Differentiation concerns the extent to which the physical therapist delivered the intervention according to the therapeutic goals of VIVA, avoiding contamination with treatments that are not part of VIVA.^55,57,58 Competence relates to the manner in which the physical therapist delivered the intervention⁵⁵; examples of competence skills include but are not limited to tailoring the intervention on participants’ characteristics,^59,60 being flexible and adapting the intervention as needed,⁶¹ communicating information clearly in an engaging and interactive way,⁶² and clarifying information and providing constructive feedback.⁶³ We aimed to record 3 sessions per participant to assess adherence, differentiation, and competence. We reviewed the Subjective, Objective, Assessment, and Plan (SOAP) notes to assess adherence and differentiation for the sessions that were not recorded. Checklists of 13 and 9 items were used to assess fidelity from recordings and SOAP notes, respectively. Items delivered as intended received a score of 1; otherwise, they were assigned a score of 0. Each session received a score based on the percentage of the checked items. We reported percentage fidelity based on recordings, percentage fidelity based on SOAP notes, and overall percentage fidelity.

Data Analysis

We presented sociodemographic data as means and standard deviations (SDs) or numbers and percentages. We reported usability data as numbers and percentages of participants who selected each of the answer options. We reported secondary outcomes as mean with a 95% CI. We did not perform any nonparametric statistics as the choice of the secondary outcomes was exploratory in nature, as the present study was not designed to test the efficacy of such outcomes, and we were underpowered to make any inferences from statistical tests using our data. All analyses were conducted with SPSS Statistics (version 29.0.0.0; IBM Corp, Armonk, NY, USA).

Role of the Funding Source

The funder played no role in the study’s design, conduct, and reporting.

Results

Development of VIVA

After consultation with patient advocates and physical therapists, the steering committee decided that VIVA should include 7 1-on-1 virtual sessions delivered by a physical therapist over 5 weeks as follows: 2 sessions per week for the first 2 weeks, and 1 session per week in the next 3 weeks (Figure). After a tech consultation session, participants complete an online survey, which included the following: demographic questions, medical history (including but not limited to information about VFs, potential other fractures or previous injuries, risk factors for fragility fracture, and exercise/physical activity habits), a questionnaire to assess the nutrition risk (SCREEN-14 questionnaire⁶⁴; https://olderadultnutritionscreening.com/screen-tools/), 1 questionnaire to assess the health status,⁴⁶ and the Exercise Self-Efficacy Questionnaire.^48–51 After the completion of the survey, participants have a 60-minute virtual intake session with the physical therapist. The physical therapist asks further questions about participants’ medical history, administers the Physical Activity Screen,⁶⁵ performs physical functioning assessments (ie, 30-second chair-stand test⁶⁶ and balance tests from the Short Physical Performance Battery⁶⁷), reviews the answers to SCREEN-14 with the participant, discusses nutritional goals and strategies, and delivers a 1-page information sheet with nutrition tips. After the intake, each virtual session lasts 45 minutes and is divided into 3 parts: education, training, and behavioral support/goal setting. In the first part of the session, after a meet and greet where the physical therapist asks whether the participant has any questions or concerns, the physical therapist chooses the education topic for the session and the following week, provides education, and delivers the associated resource (eg, 1-page information sheet, video) in Physiotec. The physical therapist then demonstrates selected exercises/safe movement/pain management strategies according to the topic chosen, and asks the participant to demonstrate it, to ensure they can execute it with the proper form. Finally, the physical therapist and the participant set the goals for the week and create a weekly action plan. The physical therapist asks the participants about preferred days and times to practice exercises and pain management strategies and then provides the prescription. The physical therapist will remind the participant to incorporate safe movement techniques and nutrition tips into their daily life. Intervention functions, behavior change techniques, and the intervention components are reported in Table 2.

Acceptability and Usability Evaluation

Fourteen individuals were screened for eligibility. Three persons declined to participate, and 2 did not meet our inclusion criteria (Tab. 3). Nine women who were 68.71 (SD = 5.65) years old and had chronic pain after VF participated. All of the participants had their last VF more than 3 months prior to the beginning of the study. At baseline, 5 participants selected the option “I have moderate pain or discomfort,” and 3 participants selected the option “I have severe pain or discomfort” from the EQ-5D-5L questionnaire. Four participants were at risk for malnutrition (SCREEN-14 score of <50).

Acceptability

Four main themes emerged from the final interviews with participants: perceived improvements in pain, increased self-confidence, satisfaction with 1-on-1 sessions and resources, and ease of use.

Perceived Improvements in Pain

Participants perceived that their pain improved as a result of participation in the VIVA prototype. Although they are aware that pain could not completely go away in 5 weeks, they felt that it might in the long term, if they kept practicing what they have learned in the program: “I could be on the road to feeling 100% better at some point if I keep doing this, hopefully” (participant 8). A few people mentioned that they were able to reduce pain or sleep medications during VIVA: “I’ve only taken pain medications once since I’ve been in your program” (participant 5).

Increased Self-Confidence

After participating in the program, participants felt more confident in their ability to control their pain and their life in general: “I was really glad that I was able to have this opportunity, because now, I can move forward, I have a better understanding of what’s going on and how to” (participant 7). Participants recognized that, during VIVA, they learned things that were easy to incorporate in their daily life: “a lot of what you had provided, I was able to transfer into other tasks that I was doing” (participant 5), and that the safe movement techniques that they learned during VIVA made their activities of daily living easier and more enjoyable.

Perception of 1-on-1 Sessions and Other Resources

Participants were very satisfied with the 1-on-1 sessions and the possibility to attend them from their home, and also with the fact that the physical therapist demonstrated the exercises/safe movement techniques, which they would perform and receive feedback on. A few participants had previous experience with nonpharmacological management of their VFs and were not satisfied with these prior treatments. Conversely, they were very happy with the content of the VIVA virtual sessions and the home exercise prescriptions: “I think all the exercises were very geared to; easy going; help you to build up stamina” (participant 8). Participants were happy to have a chance to receive clear and progressive instructions on how to resume normal activities of the daily living. For example, “[the physical therapist] went over like teaching me how to rake and how to get onto the floor and get up off the floor and in steps” (participant 2). Participants were satisfied with the 1-page information sheets, with their layout and the details of the information reported: “the pictures and the instructions were very helpful as to how to do the exercises and how many” (participant 1). Participants were extremely satisfied with the videos that were very self-explanatory for people unfamiliar with the topics.

Ease of Use

Overall, participants found VIVA easy to use. Furthermore, the fact that the physical therapist delivered the videos in the Physiotec online portal right after the 1-on-1 session was appreciated by participants, as they would go over them right away while they could still remember the explanation of the physical therapist from the session. The impressions about the personal online portal were inconsistent. Some found “that whole participation web page type thing was very, very handy” (participant 4), while others did not like having to log in and out to access their prescription and the related resources. However, participants reported printing the material, even among the participants who liked the online portal, as it was more convenient to have printed copies or take screenshots with their tablets. Some difficulties when downloading the resources was reported by a few participants, and a few asked to have the resources mailed to them as they did not have a printer available. Adherence tracking was an issue, as participants did not like to have to log in to track their adherence.

Usability

All the participants believed that VIVA was very useful and were very satisfied with the 1-on-1 sessions. Four participants (44%) found the information received very easy to practice, 4 participants (44%) believed they were easy to practice, and 1 participant (11%) found them somewhat difficult. Five participants (56%) were satisfied, and 4 (44%) were very satisfied with the supporting resources delivered throughout the program (Tab. 4).

Secondary Outcomes

Mean changes and confidence intervals show potential for statistically significant changes in participants’ ability to make concrete plans about when, how, where, and how often to exercise (Tab. 5). All the participants completed baseline and postintervention assessments, and all the participants attended 7 1-on-1 sessions. Only 2 participants tracked adherence to the home program: 1 participant completed all the daily home sessions, 1 participant completed 27/28 sessions. Two participants recorded adherence for only 2 weeks and 1 week, respectively. Four participants did not report adherence. No adverse events attributable to the intervention occurred.

Intervention Delivery Fidelity

Two participants did not provide consent to have their sessions recorded, whereas 6 sessions could not be recorded due to technical problems (eg, connection issues). Therefore, we assessed intervention delivery fidelity from 12 recordings and 44 SOAP notes. Overall fidelity percentages were 95.5% when assessed with recordings and 95.6% when assessed with SOAP notes. The fidelity percentages of the delivery of each part of the session were 85.3% for education, 98.0% for training, and 98.0% for behavioral support/goal setting.

Discussion

VIVA was acceptable to the participants with VF, who were very satisfied with the perceived benefits in terms of reduced pain, increased self-confidence in their ability to manage pain and perform their activities of daily living, and the opportunity to receive the treatment directly from their homes. Overall, participants were satisfied with the online portal, although most of them preferred to download and print the home program and the resources. Tracking adherence through the online portal was not completed by most of the participants.

Participants were very satisfied with the program and the 1-on-1 sessions, and were satisfied with the supporting resources. The engagement of potential end users since the research design phase likely contributed to the high levels of acceptability and usability. The resources, the contents, and the timeline of the program reflect the needs of patients and physical therapists, whose input ensured that VIVA was easy to use and as close as possible to the real-world scenario. Our results are in line with those from Katzman et al,¹⁸ who delivered an exercise and posture training program via video clip viewing and text messaging reminders to adults with hyperkyphosis, where the virtual program was found to be feasible and acceptable to participants. Acceptability and usability of telerehabilitation are usually high among patients with cancer,¹⁹ cardiovascular disease,^20–22 or rheumatic diseases.²³ Considering that people with VFs face unique issues, such as fear of moving, falling or (re)fracturing, poorer metal health, and pain catastrophizing (Ponzano et al, manuscript in preparation),³⁵ determining the acceptability and usability of VIVA was a necessary step before implementing it on a larger scale.

A few participants reported increased confidence in their ability to manage pain and, although the nature of our study does not allow to make final inferences from quantitative data, the increase in the self-reported measures of action planning is in line with the perception of participants that emerged from the qualitative interviews. Participants had high exercise self-efficacy at baseline, and self-efficacy is fundamental for the formation of specific action plans, and has also been shown to predict the successful adoption and maintenance of healthy behaviors, as well as enhance the sustainability of clinical improvements.^68,69 Participants had high levels of intention planning at baseline and, given the mediating role of action planning and self-efficacy between the intention and the adoption and maintenance of healthy behaviors,⁷⁰ exploring whether action planning and self-efficacy mediate the effects of VIVA on the adoption and maintenance of the target behaviors would guide researchers and clinicians in designing more effective interventions utilizing the most appropriate behavior change techniques for people with VFs.

The next steps in the implementation of VIVA will be to test its feasibility of recruitment, retention, and adherence. If VIVA will prove to be feasible, a subsequent RCT will test whether the intervention improves outcomes relevant to patients, such as physical functioning or pain. This study provided valuable insights for the implementation of VIVA. A hybrid option that combines an online portal and paper-based resources, which allows participants to visualize their prescription and pictures without having to log into their participant portal, would likely be more acceptable to participants. For instance, the physical therapist might email the resources and the prescription to the participants at the end of each session; mailing resources may be an acceptable option, although less pragmatic, for those participants who do not have access to a printer. Adherence tracking was the biggest concern of VIVA, as most participants did not find logging in the online portal just to report adherence convenient. Daily diaries where 1-page recording sheets designed like a weekly calendar worked well in a home-exercise program for people with VF,⁵⁴ whereas daily text messages to which participants had to reply by text with 1 (if they practiced the program) or 0 (if they did not) were feasible and acceptable to adults with hyperkyphosis.¹⁸ Paper-based daily calendars or text messages prompts to track adherence will warrant further exploration in the next steps of VIVA.

This study presents some limitations. As a virtually delivered intervention, involving 1-on-1 virtual sessions with a physical therapist, and the delivery of pictures and videos, VIVA cannot be delivered to people who do not have access to technology. The efficacy and effectiveness of the recommendations for the nonpharmacological management of VFs among people with no access to technology will have to be assessed with in-person interventions. Only women with chronic VFs expressed interest to participate in the study; therefore, we cannot generalize our findings to men or individuals with acute VFs. People with an acute VF experience excruciating and debilitating pain that limits their mobility and causes fear of moving and of increasing pain.³⁵ However, early mobilization, along with exercises for spine mobility and endurance, should be performed in the acute phase as tolerated.³¹ Therefore, exploring the acceptability of VIVA among people with acute VF would provide further insights for clinical practice. Furthermore, the lower prevalence of osteoporosis and fragility fractures in men hinders the identification and the recruitment of participants who are male. As such, other potential future developments of VIVA may consider targeting only individuals with acute fracture and men, to assess acceptability, usability, and feasibility in these subpopulations. The average age of the participants was <70 years, and the acceptability and usability of VIVA to participants who are older might be different. Qualitative studies and self-reported outcomes can present some social desirability bias, whereas the evaluation of intervention delivery fidelity was performed by 1 of the authors (M.P.), with some potential for information bias. Finally, APEASE criteria informed the design and the acceptability and usability evaluation of the intervention; however, they were not evaluated as outcomes, as part of them were beyond the scope of the present project.

Conclusion

VIVA was acceptable to the participants, who perceived improvements in pain and self-confidence. Participants believed that VIVA was easy to use, and the exercises were easy to practice, although a hybrid model with both online and printed resources might be preferred. A successful implementation of VIVA on a larger scale will bridge the gap from knowledge to practice in the prescription of nonpharmacological strategies for the prevention and treatment of VFs.

Author Contributions

Matteo Ponzano (Conceptualization [equal], Data curation [lead], Formal analysis [lead], Investigation [lead], Methodology [equal], Project administration [equal], Resources [equal], Software [equal], Supervision [equal], Validation [equal], Visualization [equal], Writing—original draft [lead], Writing—review & editing [equal]), Nicholas Tibert (Data curation [equal], Writing—review & editing [equal]), Sheila Brien (conceptualization [equal], Methodology [equal]), Larry Funnell (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Jenna C. Gibbs (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Heather Keller (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Judi Laprade (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Suzanne N. Morin (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Alexandra Papaioannou (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Zachary J. Weston (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), Timothy H. Wideman (Conceptualization [equal], Methodology [equal], Writing—review & editing [equal]), and Lora M. Giangregorio (Conceptualization [equal], Funding acquisition [lead], Investigation [equal], Methodology [lead], Project administration [lead], Resources [lead], Software [lead], Supervision [lead], Validation [equal], Visualization [equal], Writing—review & editing [lead])

Acknowledgments

The authors thank Lesley Hughes, MScPT, for delivering the intervention.

Ethics Approval

This study received ethics approval from the University of Waterloo Research Ethics Board (ORE #43705).

Funding

This study was funded by the CIHR-IMHA Canadian Musculoskeletal Rehab Research Network (grant CIHR FRN: CFI-148081). The authors acknowledge the support of the Natural Sciences and Engineering Research Council of Canada (NSERC), CREATE 509950–2018 Training in Global Biomedical Technology Research and Innovation.

Data Availability

The data are available from the author upon reasonable request.

Disclosures

The authors completed the ICMJE Form for Disclosure of Potential Conflicts of Interest and reported no conflicts of interest. The thesis this is adapted from is a dissertation posted on UWSpace, Waterloo’s institutional repository (https://uwspace.uwaterloo.ca/handle/10012/18674).

References