Development and feasibility of stratified primary care physiotherapy integrated with eHealth in patients with neck and/or shoulder complaints: results of a mixed methods study.

BACKGROUND: Providing individualized care based on the context and preferences of the patient is important. Knowledge on both prognostic risk stratification and blended eHealth care in musculoskeletal conditions is increasing and seems promising. Stratification can be used to match patients to the most optimal content and intensity of treatment as well as mode of treatment delivery (i.e. face-to-face or blended with eHealth). However, research on the integration of stratified and blended eHealth care with corresponding matched treatment options for patients with neck and/or shoulder complaints is lacking. METHODS: This study was a mixed methods study comprising the development of matched treatment options, followed by an evaluation of the feasibility of the developed Stratified Blended Physiotherapy approach. In the first phase, three focus groups with physiotherapists and physiotherapy experts were conducted. The second phase investigated the feasibility (i.e. satisfaction, usability and experiences) of the Stratified Blended Physiotherapy approach for both physiotherapists and patients in a multicenter single-arm convergent parallel mixed methods feasibility study. RESULTS: In the first phase, matched treatment options were developed for six patient subgroups. Recommendations for content and intensity of physiotherapy were matched to the patient's risk of persistent disabling pain (using the Keele STarT MSK Tool: low/medium/high risk). In addition, selection of mode of treatment delivery was matched to the patient's suitability for blended care (using the Dutch Blended Physiotherapy Checklist: yes/no). A paper-based workbook and e-Exercise app modules were developed as two different mode of treatment delivery options, to support physiotherapists. Feasibility was evaluated in the second phase. Physiotherapists and patients were mildly satisfied with the new approach. Usability of the physiotherapist dashboard to set up the e-Exercise app was considered 'OK' by physiotherapists. Patients considered the e-Exercise app to be of 'best imaginable' usability. The paper-based workbook was not used. CONCLUSION: Results of the focus groups led to the development of matched treatment options. Results of the feasibility study showed experiences with integrating stratified and blended eHealth care and have informed amendments to the Stratified Blended Physiotherapy approach for patients with neck and/or shoulder complaints ready to use within a future cluster randomized trial.

Stratified care integrated with eHealth versus usual primary care physiotherapy in patients with neck and/or shoulder complaints: protocol for a cluster randomized controlled trial.

BACKGROUND: Neck and shoulder complaints are common in primary care physiotherapy. These patients experience pain and disability, resulting in high societal costs due to, for example, healthcare use and work absence. Content and intensity of physiotherapy care can be matched to a patient's risk of persistent disabling pain. Mode of care delivery can be matched to the patient's suitability for blended care (integrating eHealth with physiotherapy sessions). It is hypothesized that combining these two approaches to stratified care (referred to from this point as Stratified Blended Approach) will improve the effectiveness and cost-effectiveness of physiotherapy for patients with neck and/or shoulder complaints compared to usual physiotherapy. METHODS: This paper presents the protocol of a multicenter, pragmatic, two-arm, parallel-group, cluster randomized controlled trial. A total of 92 physiotherapists will be recruited from Dutch primary care physiotherapy practices. Physiotherapy practices will be randomized to the Stratified Blended Approach arm or usual physiotherapy arm by a computer-generated random sequence table using SPSS (1:1 allocation). Number of physiotherapists (1 or > 1) will be used as a stratification variable. A total of 238 adults consulting with neck and/or shoulder complaints will be recruited to the trial by the physiotherapy practices. In the Stratified Blended Approach arm, physiotherapists will match I) the content and intensity of physiotherapy care to the patient's risk of persistent disabling pain, categorized as low, medium or high (using the Keele STarT MSK Tool) and II) the mode of care delivery to the patient's suitability and willingness to receive blended care. The control arm will receive physiotherapy as usual. Neither physiotherapists nor patients in the control arm will be informed about the Stratified Blended Approach arm. The primary outcome is region-specific pain and disability (combined score of Shoulder Pain and Disability Index & Neck Pain and Disability Scale) over 9 months. Effectiveness will be compared using linear mixed models. An economic evaluation will be performed from the societal and healthcare perspective. DISCUSSION: The trial will be the first to provide evidence on the effectiveness and cost-effectiveness of the Stratified Blended Approach compared with usual physiotherapy in patients with neck and/or shoulder complaints. TRIAL REGISTRATION: Netherlands Trial Register: NL8249 . Officially registered since 27 December 2019. Date of first enrollment: 30 September 2020. Study status: ongoing, data collection.

Effectiveness and cost-effectiveness of stratified blended physiotherapy in patients with non-specific low back pain: study protocol of a cluster randomized controlled trial.

BACKGROUND: Patient education, advice on returning to normal activities and (home-based) exercise therapy are established treatment options for patients with non-specific low back pain (LBP). However, the effectiveness of physiotherapy interventions on physical functioning and prevention of recurrent events largely depends on patient self-management, adherence to prescribed (home-based) exercises and recommended physical activity behaviour. Therefore we have developed e-Exercise LBP, a blended intervention in which a smartphone application is integrated within face-to-face care. E-Exercise LBP aims to improve patient self-management skills and adherence to exercise and physical activity recommendations and consequently improve the effectiveness of physiotherapy on patients' physical functioning. The aim of this study is to investigate the short- (3 months) and long-term (12 and 24 months) effectiveness on physical functioning and cost-effectiveness of e-Exercise LBP in comparison to usual primary care physiotherapy in patients with LBP. METHODS: This paper presents the protocol of a prospective, multicentre cluster randomized controlled trial. In total 208 patients with LBP pain were treated with either e-Exercise LBP or usual care physiotherapy. E-Exercise LBP is stratified based on the risk for developing persistent LBP. Physiotherapists are able to monitor and evaluate treatment progress between face-to-face sessions using patient input from the smartphone application in order to optimize physiotherapy care. The smartphone application contains video-supported self-management information, video-supported exercises and a goal-oriented physical activity module. The primary outcome is physical functioning at 12-months follow-up. Secondary outcomes include pain intensity, physical activity, adherence to prescribed (home-based) exercises and recommended physical activity behaviour, self-efficacy, patient activation and health-related quality of life. All measurements will be performed at baseline, 3, 12 and 24 months after inclusion. An economic evaluation will be performed from the societal and the healthcare perspective and will assess cost-effectiveness of e-Exercise LBP compared to usual physiotherapy at 12 and 24 months. DISCUSSION: A multi-phase development and implementation process using the Center for eHealth Research Roadmap for the participatory development of eHealth was used for development and evaluation. The findings will provide evidence on the effectiveness of blended care for patients with LBP and help to enhance future implementation of blended physiotherapy. TRIAL REGISTRATION: ISRCTN, ISRCTN94074203. Registered 20 July 2018 - Retrospectively registered.

A Blended Physiotherapy Intervention for Persons With Hemophilic Arthropathy: Development Study.

BACKGROUND: Joint bleeds are the hallmark of hemophilia, leading to a painful arthritic condition called as hemophilic arthropathy (HA). Exercise programs are frequently used to improve the physical functioning in persons with HA. As hemophilia is a rare disease, there are not many physiotherapists who are experienced in the field of hemophilia, and regular physiotherapy sessions with an experienced physiotherapist in the field of hemophilia are not feasible for persons with HA. Blended care is an innovative intervention that can support persons with HA at home to perform the advised physical activities and exercises and provide self-management information. OBJECTIVE: The aim of this study was to develop a blended physiotherapy intervention for persons with HA. METHODS: The blended physiotherapy intervention, namely, e-Exercise HA was developed by cocreation with physiotherapists, persons with HA, software developers, and researchers. The content of e-Exercise HA was compiled using the first 3 steps of the Center for eHealth Research roadmap model (ie, contextual inquiry, value specification, and design), including people with experience in the development of previous blended physiotherapy interventions, a literature search, and focus groups. RESULTS: A 12-week blended intervention was developed, integrating face-to-face physiotherapy sessions with a web-based app. The intervention consists of information modules for persons with HA and information modules for physiotherapists, a graded activity program using a self-chosen activity, and personalized video-supported exercises. The information modules consist of text blocks, videos, and reflective questions. The patients can receive pop-ups as reminders and give feedback on the performance of the prescribed activities. CONCLUSIONS: In this study, we developed a blended physiotherapy intervention for persons with HA, which consists of information modules, a graded activity program, and personalized video-supported exercises.

Development of a Checklist to Assist Physiotherapists in Determination of Patients' Suitability for a Blended Treatment.

Background: The integration of digital applications within health care is called blended care. Introduction: Despite its potential, physiotherapists experience difficulty in determining which patients are suitable for blended care. This study aimed to develop a checklist to support physiotherapists while setting up a blended treatment. Therefore, we aimed to investigate which patient characteristics predict patients' suitability for blended physiotherapy and which patient characteristics need to be taken into account while determining the ratio between therapeutic guidance and a digital application. Methods: A scoping review was conducted consisting of (1) literature search in PubMed and PEDro up to December 2017: studies were eligible if they focused on blended physiotherapy consisting of contact at least twice with a physiotherapist complemented by a digital application, and characteristics related to patients' suitability for blended physiotherapy were extracted and categorized in themes; (2) a checklist item for each theme formulated by the authors, which resulted in a first version of the Dutch Blended Physiotherapy Checklist; and (3) expert opinion and feedback on clinical relevance by six experts. The checklist was adapted accordingly. Results: The final Dutch Blended Physiotherapy Checklist consists of eight items: motivation, safety, equipment, digital skills, health literacy, self-management, time, and financial factors. Discussion: The next step is to investigate the feasibility and predictive validity of the checklist, that is, whether this checklist is actually able to predict patients' suitability for blended physiotherapy. Conclusions: This study provides the final version of the Dutch Blended Physiotherapy Checklist, which is supposed to guide physiotherapists in their clinical reasoning process while setting up a personalized, blended physiotherapy treatment.

Cost-effectiveness of a blended physiotherapy intervention compared to usual physiotherapy in patients with hip and/or knee osteoarthritis: a cluster randomized controlled trial.

BACKGROUND: Blended physiotherapy, in which physiotherapy sessions and an online application are integrated, might support patients in taking an active role in the management of their chronic condition and may reduce disease related costs. The aim of this study was to evaluate the cost-effectiveness of a blended physiotherapy intervention (e-Exercise) compared to usual physiotherapy in patients with osteoarthritis of hip and/or knee, from the societal as well as the healthcare perspective. METHODS: This economic evaluation was conducted alongside a 12-month cluster randomized controlled trial, in which 108 patients received e-Exercise, consisting of physiotherapy sessions and a web-application, and 99 patients received usual physiotherapy. Clinical outcome measures were quality-adjusted life years (QALYs) according to the EuroQol (EQ-5D-3 L), physical functioning (HOOS/KOOS) and physical activity (Actigraph Accelerometer). Costs were measured using self-reported questionnaires. Missing data were multiply imputed and bootstrapping was used to estimate statistical uncertainty. RESULTS: Intervention costs and medication costs were significantly lower in e-Exercise compared to usual physiotherapy. Total societal costs and total healthcare costs did not significantly differ between groups. No significant differences in effectiveness were found between groups. For physical functioning and physical activity, the maximum probability of e-Exercise being cost-effective compared to usual physiotherapy was moderate (< 0.82) from both perspectives. For QALYs, the probability of e-Exercise being cost-effective compared to usual physiotherapy was 0.68/0.84 at a willingness to pay of 10,000 Euro and 0.70/0.80 at a willingness to pay of 80,000 Euro per gained QALY, from respectively the societal and the healthcare perspective. CONCLUSIONS: E-Exercise itself was significantly cheaper compared to usual physiotherapy in patients with hip and/or knee osteoarthritis, but not cost-effective from the societal- as well as healthcare perspective. The decision between both interventions can be based on the preferences of the patient and the physiotherapist. TRIAL REGISTRATION: NTR4224 (25 October 2013).

Determinants of Adherence to the Online Component of a Blended Intervention for Patients with Hip and/or Knee Osteoarthritis: A Mixed Methods Study Embedded in the e-Exercise Trial.

BACKGROUND: Embedding Web-based interventions within physiotherapy has potential, but knowledge on patient adherence to these interventions is limited. INTRODUCTION: This study explores which patient-, intervention-, and environment-related factors are determinants of adherence to the online component of e-Exercise, a 12-week blended intervention for patients with hip and/or knee osteoarthritis. METHODS: A convergent mixed methods study was performed, embedded within an ongoing trial. Quantitative data of 109 participants that received e-Exercise were used for negative binomial regression analysis. Adherence was defined as the number of online evaluated weeks. Next, semistructured interviews on factors related to adherence to the online component were analyzed. RESULTS: Nineteen participants with missing outcome data because their program was not started were excluded. Of the 90 analyzed participants, 81.1% were evaluated for at least 8 weeks. Adherence was highest for participants with middle education, 1-5-year osteoarthritis duration, and participants who were physiotherapist recruited. The 10 analyzed interviews revealed that sufficient Internet skills, self-discipline, execution of the exercise plan, the intervention's usability, flexibility, persuasive design, added value, and acceptable required time, and research participation were linked to favorable adherence. DISCUSSION: It is unknown if patients who adhered to the online component also adhered to their exercise plans. The relationship between adherence to the online component and clinical outcomes will be addressed in a future study. CONCLUSIONS: The majority of the participants adhered to the online component of e-Exercise, illustrating its applicability. The integration within the physiotherapy setting and intervention's persuasive design appear to have an important role in optimizing patient adherence.

Effectiveness and cost-effectiveness of a blended exercise intervention for patients with hip and/or knee osteoarthritis: study protocol of a randomized controlled trial.

BACKGROUND: Exercise therapy in patients with hip and/or knee osteoarthritis is effective in reducing pain, increasing physical activity and physical functioning, but costly and a burden for the health care budget. A web-based intervention is cheap in comparison to face-to-face exercise therapy and has the advantage of supporting in home exercises because of the 24/7 accessibility. However, the lack of face-to-face contact with a professional is a disadvantage of web-based interventions and is probably one of the reasons for low adherence rates. In order to combine the best of two worlds, we have developed the intervention e-Exercise. In this blended intervention face-to-face contacts with a physical therapist are partially replaced by a web-based exercise intervention. The aim of this study is to investigate the short- (3 months) and long-term (12 months) (cost)-effectiveness of e-Exercise compared to usual care physical therapy. Our hypothesis is that e-Exercise is more effective and cost-effective in increasing physical functioning and physical activity compared to usual care. METHODS/DESIGN: This paper presents the protocol of a prospective, single-blinded, multicenter cluster randomized controlled trial. In total, 200 patients with OA of the hip and/or knee will be randomly allocated into either e-Exercise or usual care (physical therapy). E-Exercise is a 12-week intervention, consisting of maximum five face-to-face physical therapy contacts supplemented with a web-based program. The web-based program contains assignments to gradually increase patients' physical activity, strength and stability exercises and information about OA related topics. Primary outcomes are physical activity and physical functioning. Secondary outcomes are health related quality of life, self-perceived effect, pain, tiredness and self-efficacy. All measurements will be performed at baseline, 3 and 12 months after inclusion. Retrospective cost questionnaires will be sent at 3, 6, 9 and 12 months and used for the cost-effectiveness and cost-utility analysis. DISCUSSION: This study is the first randomized controlled trial in the (cost)-effectiveness of a blended exercise intervention for patients with osteoarthritis of the hip and/or knee. The findings will help to improve the treatment of patients with osteoarthritis. TRIAL REGISTRATION: NTR4224.

Exploring needs and requirements for a prototype device measuring physical activity in pediatric physical therapy: A qualitative study.

AIMS: To analyze needs and requirements of Pediatric Physical Therapists (PPTs), parents, children and adolescents with and without developmental disabilities in the future use of an activity monitor prototype (AM-p) in everyday clinical practice. METHODS: Qualitative exploratory study with a thematic analysis approach, based on Braun and Clarke's six steps. Codes derived from the analysis and central themes were collated, based on Fleuren et al.'s groupings of determinants. RESULTS: We interviewed 25 PPTs, 12 parents, and 12 children and adolescents. Within four groupings of determinants, we found nine themes: 1) development of information materials; 2) application: output visualization and ease of use; 3) design; 4) relevance and acceptance; 5) shared decision-making; 6) compatibility in daily living; 7) finances, 8) time, and 9) legislation and regulations. CONCLUSIONS: End-users have similar basic needs, with individual fine-tuning to be addressed during further development of the AM-p. A child-friendly design, information material, and an easy-to-use application to read and interpret results, need to be developed. Efficient training for PPTs is important for the use of the AM-p and analysis of results. Communication between PPTs and children as well as parents enhances shared decision-making. We recommend involving diverse end-users to enable maximum customization of the AM-p.

Pain Coping and Healthcare Use in Patients with Early Knee and/or Hip Osteoarthritis: 10-Year Follow-Up Data from the Cohort Hip and Cohort Knee (CHECK) Study.

BACKGROUND: Knee and hip osteoarthritis (OA) among older adults account for substantial disability and extensive healthcare use. Effective pain coping strategies help to deal with OA. This study aims to determine the long-term relationship between pain coping style and the course of healthcare use in patients with knee and/or hip OA over 10 years. METHODS: Baseline and 10-year follow-up data of 861 Dutch participants with early knee and/or hip OA from the Cohort Hip and Cohort Knee (CHECK) cohort were used. The amount of healthcare use (HCU) and pain coping style were measured. Generalized Estimating Equations were used, adjusted for relevant confounders. RESULTS: At baseline, 86.5% of the patients had an active pain coping style. Having an active pain coping style was significantly (p = 0.022) associated with an increase of 16.5% (95% CI, 2.0-32.7) in the number of used healthcare services over 10 years. CONCLUSION: Patients with early knee and/or hip OA with an active pain coping style use significantly more different healthcare services over 10 years, as opposed to those with a passive pain coping style. Further research should focus on altered treatment (e.g., focus on self-management) in patients with an active coping style, to reduce HCU.

Trajectories of Adherence to Home-Based Exercise Recommendations Among People With Low Back Pain: A Longitudinal Analysis.

OBJECTIVE: This study aimed to examine the presence of distinct trajectories of adherence to home-based exercise recommendations among people with low back pain (LBP). This study also aimed to identify differences in baseline characteristics among groups. METHODS: This study was a secondary analysis of a prospective, multicenter cluster randomized controlled trial investigating the cost-effectiveness of a stratified blended physical therapist intervention compared to usual care physical therapy in patients with LBP. The intervention group received usual care with integrated support via a smartphone app. A total of 208 patients were recruited from 58 primary care physical therapist practices. Baseline data included patient characteristics, physical functioning, pain intensity, physical activity, fear avoidance, pain catastrophizing, self-efficacy, self-management ability, and health-related quality of life. The Exercise Adherence Scale (score range = 0-100) was used to measure adherence during each treatment session. Latent class growth analysis was used to estimate trajectories of adherence. RESULTS: Adherence data were available from 173 out of 208 patients (83%). Data were collected during an average of 5.1 (standard deviation [SD] = 2.5) treatment sessions, with total treatment duration of 51 (SD = 41.7) days. Three trajectory classes were identified: "declining adherence" (12%), "stable adherence" (45%), and "increasing adherence" (43%). No differences in baseline characteristic were found between groups. CONCLUSION: Three adherence trajectories to exercise recommendations were identified in patients with LBP. However, baseline characteristics cannot identify a patient's trajectory group. IMPACT: Despite the presence of distinct trajectories of adherence in patients with LBP, physical therapists should not attempt to place a patient in a trajectory group at the start of treatment. Instead, adherence should be closely monitored as treatment progresses and supported when required as part of an ongoing process.

Validity and reliability of the Dutch STarT MSK tool in patients with musculoskeletal pain in primary care physiotherapy.

OBJECTIVE: To evaluate the validity and reliability of the Dutch STarT MSK tool in patients with musculoskeletal pain in primary care physiotherapy. METHODS: Physiotherapists included patients with musculoskeletal pain, aged 18 years or older. Patients completed a questionnaire at baseline and follow-up at 5 days and 3 months, respectively. Construct validity was assessed by comparing scores of STarT MSK items with reference questionnaires. Pearson's correlation coefficients were calculated to test predefined hypotheses. Test-retest reliability was evaluated by calculating quadratic-weighted kappa coefficients for overall STarT MSK tool scores (range 0-12) and prognostic subgroups (low, medium and high risk). Predictive validity was assessed by calculating relative risk ratios for moderate risk and high risk, both compared with low risk, in their ability to predict persisting disability at 3 months. RESULTS: In total, 142 patients were included in the analysis. At baseline, 74 patients (52.1%) were categorised as low risk, 64 (45.1%) as medium risk and 4 (2.8%) as high risk. For construct validity, nine of the eleven predefined hypotheses were confirmed. For test-retest reliability, kappa coefficients for the overall tool scores and prognostic subgroups were 0.71 and 0.65, respectively. For predictive validity, relative risk ratios for persisting disability were 2.19 (95% CI: 1.10-4.38) for the medium-risk group and 7.30 (95% CI: 4.11-12.98) for the high-risk group. CONCLUSION: The Dutch STarT MSK tool showed a sufficient to good validity and reliability in patients with musculoskeletal pain in primary care physiotherapy. The sample size for high-risk patients was small (n = 4), which may limit the generalisability of findings for this group. An external validation study with a larger sample of high-risk patients (≥50) is recommended.

Physiotherapists' experiences with a blended osteoarthritis intervention: a mixed methods study.

INTRODUCTION: E-Exercise is an effective 12-week blended intervention consisting of around five face-to-face physiotherapy sessions and a web-based application for patients with hip/knee osteoarthritis. In order to facilitate effective implementation of e-Exercise, this study aims to identify physiotherapists' experiences and determinants related to the usage of e-Exercise. Methods: An explanatory sequential mixed methods design embedded in a randomized controlled trial comparing e-Exercise with usual physiotherapy in patients with hip/knee osteoarthritis. Usage of e-Exercise was based on recruitment rates of 123 physiotherapists allocated to e-Exercise and objective web-based application usage data. Experiences and determinants related to e-Exercise usage were investigated with a questionnaire and clarified with semi-structured interviews. Results: Of the 123 physiotherapists allocated to e-Exercise, 54 recruited more than one eligible patient, of whom 10 physiotherapists continued using e-Exercise after the study period. Physiotherapists had mixed experiences with e-Exercise. Determinants related to intervention usage were appropriateness, added value, time, workload, professional autonomy, environmental factors, and financial consequences. Physiotherapists recommended to improve the ability to tailor e-Exercise to the individual needs of the patient patients' individual needs. Discussion: Determinants related to the usage of e-Exercise provided valuable information for the implementation of e-Exercise on broader scale. Most importantly, the flexibility of e-Exercise needs to be improved. Next, there is a need for education on how to integrate an online program within physiotherapy.

Effectiveness of a Blended Physical Therapist Intervention in People With Hip Osteoarthritis, Knee Osteoarthritis, or Both: A Cluster-Randomized Controlled Trial.

Background: Integrating physical therapy sessions and an online application (e-Exercise) might support people with hip osteoarthritis (OA), knee OA, or both (hip/knee OA) in taking an active role in the management of their chronic condition and may reduce the number of physical therapy sessions. Objective: The objective of this study was to investigate the short- and long-term effectiveness of e-Exercise compared to usual physical therapy in people with hip/knee OA. Design: The design was a prospective, single-blind, multicenter, superiority, cluster- randomized controlled trial. Setting: The setting included 143 primary care physical therapist practices. Participants: The participants were 208 people who had hip/knee OA and were 40 to 80 years of age. Intervention: e-Exercise is a 3-month intervention in which about 5 face-to-face physical therapy sessions were integrated with an online application consisting of graded activity, exercise, and information modules. Usual physical therapy was conducted according to the Dutch physical therapy guidelines on hip and knee OA. Measurements: Primary outcomes, measured at baseline after 3 and 12 months, were physical functioning and free-living physical activity. Secondary outcome measures were pain, tiredness, quality of life, self-efficacy, and the number of physical therapy sessions. Results: The e-Exercise group (n = 109) received, on average, 5 face-to-face sessions; the usual physical therapy group (n = 99) received 12. No significant differences in primary outcomes between the e-Exercise group and the usual physical therapy group were found. Within-group analyses for both groups showed a significant improvement in physical functioning. After 3 months, participants in the e-Exercise group reported an increase in physical activity; however, no objectively measured differences in physical activity were found. With respect to secondary outcomes, after 12 months, sedentary behavior significantly increased in the e-Exercise group compared with the usual physical therapy group. In both groups, there were significant improvements for pain, tiredness, quality of life, and self-efficacy. Limitations: The response rate at 12 months was 65%. Conclusions: The blended intervention, e-Exercise, was not more effective than usual physical therapy in people with hip/knee OA.