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      Development and evaluation of a tailored e-self-management intervention (dr. Bart app) for knee and/or hip osteoarthritis: study protocol

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          Abstract

          Background

          This paper describes (the development of) an eHealth tool (dr. Bart app) to enhance self-management and to optimize non-surgical health care utilization in patients with knee and/or hip osteoarthritis (OA) and presents a study aiming 1) to study the effectiveness of the dr. Bart app on health care use 2) to explore differences in use, usability and the clinical outcomes of the dr. Bart app between the Netherlands and Germany.

          Methods

          The dr. Bart app is a fully automated eHealth application and is based on the Fogg model for behavioural change, augmented with reminders, rewards and self-monitoring to reinforce app engagement and health behaviour. The dr. Bart app propose goals to a healthier lifestyle based on machine learning techniques fed by data collected in a personal profile and choosing behaviour of the app user. Patients ≥50 years with self-reported knee and/or hip OA will be eligible to participate. Participants will be recruited in the community through advertisements in local newspapers and campaigns on social media. This protocol presents a study with three arms, aiming to include 161 patients in each arm. In the Netherlands, patients are randomly allocated to usual care or dr. Bart app and in Germany all patients receive the dr. Bart app. The primary outcome of the first research question is the number of self-reported consultations in secondary health care. The primary outcome of the second research question (comparison between the Netherlands and Germany) is self-management behaviour assessed by the patient activation measure (PAM-13) questionnaire. Secondary outcomes are costs, health-related quality of life, physical functioning and activity, pain, use and usability of the dr. Bart app. Data will be collected through three online questionnaires (at baseline and after 3 and 6 months after inclusion).

          Discussion

          This study will gain insight into the effectiveness of the dr. Bart app in the (conservative) treatment of patients with knee and/or hip OA and differences in the use and usability of the dr. Bart app between the Netherlands and Germany.

          Trial registration

          Dutch Trial Register (Trial Number NTR6693 / NL6505). Registration date: 4 September 2017.

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          Most cited references45

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          OARSI recommendations for the management of hip and knee osteoarthritis, Part II: OARSI evidence-based, expert consensus guidelines.

          To develop concise, patient-focussed, up to date, evidence-based, expert consensus recommendations for the management of hip and knee osteoarthritis (OA), which are adaptable and designed to assist physicians and allied health care professionals in general and specialist practise throughout the world. Sixteen experts from four medical disciplines (primary care, rheumatology, orthopaedics and evidence-based medicine), two continents and six countries (USA, UK, France, Netherlands, Sweden and Canada) formed the guidelines development team. A systematic review of existing guidelines for the management of hip and knee OA published between 1945 and January 2006 was undertaken using the validated appraisal of guidelines research and evaluation (AGREE) instrument. A core set of management modalities was generated based on the agreement between guidelines. Evidence before 2002 was based on a systematic review conducted by European League Against Rheumatism and evidence after 2002 was updated using MEDLINE, EMBASE, CINAHL, AMED, the Cochrane Library and HTA reports. The quality of evidence was evaluated, and where possible, effect size (ES), number needed to treat, relative risk or odds ratio and cost per quality-adjusted life years gained were estimated. Consensus recommendations were produced following a Delphi exercise and the strength of recommendation (SOR) for propositions relating to each modality was determined using a visual analogue scale. Twenty-three treatment guidelines for the management of hip and knee OA were identified from the literature search, including six opinion-based, five evidence-based and 12 based on both expert opinion and research evidence. Twenty out of 51 treatment modalities addressed by these guidelines were universally recommended. ES for pain relief varied from treatment to treatment. Overall there was no statistically significant difference between non-pharmacological therapies [0.25, 95% confidence interval (CI) 0.16, 0.34] and pharmacological therapies (ES=0.39, 95% CI 0.31, 0.47). Following feedback from Osteoarthritis Research International members on the draft guidelines and six Delphi rounds consensus was reached on 25 carefully worded recommendations. Optimal management of patients with OA hip or knee requires a combination of non-pharmacological and pharmacological modalities of therapy. Recommendations cover the use of 12 non-pharmacological modalities: education and self-management, regular telephone contact, referral to a physical therapist, aerobic, muscle strengthening and water-based exercises, weight reduction, walking aids, knee braces, footwear and insoles, thermal modalities, transcutaneous electrical nerve stimulation and acupuncture. Eight recommendations cover pharmacological modalities of treatment including acetaminophen, cyclooxygenase-2 (COX-2) non-selective and selective oral non-steroidal anti-inflammatory drugs (NSAIDs), topical NSAIDs and capsaicin, intra-articular injections of corticosteroids and hyaluronates, glucosamine and/or chondroitin sulphate for symptom relief; glucosamine sulphate, chondroitin sulphate and diacerein for possible structure-modifying effects and the use of opioid analgesics for the treatment of refractory pain. There are recommendations covering five surgical modalities: total joint replacements, unicompartmental knee replacement, osteotomy and joint preserving surgical procedures; joint lavage and arthroscopic debridement in knee OA, and joint fusion as a salvage procedure when joint replacement had failed. Strengths of recommendation and 95% CIs are provided. Twenty-five carefully worded recommendations have been generated based on a critical appraisal of existing guidelines, a systematic review of research evidence and the consensus opinions of an international, multidisciplinary group of experts. The recommendations may be adapted for use in different countries or regions according to the availability of treatment modalities and SOR for each modality of therapy. These recommendations will be revised regularly following systematic review of new research evidence as this becomes available.
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            Persuasive System Design Does Matter: A Systematic Review of Adherence to Web-Based Interventions

            Background Although web-based interventions for promoting health and health-related behavior can be effective, poor adherence is a common issue that needs to be addressed. Technology as a means to communicate the content in web-based interventions has been neglected in research. Indeed, technology is often seen as a black-box, a mere tool that has no effect or value and serves only as a vehicle to deliver intervention content. In this paper we examine technology from a holistic perspective. We see it as a vital and inseparable aspect of web-based interventions to help explain and understand adherence. Objective This study aims to review the literature on web-based health interventions to investigate whether intervention characteristics and persuasive design affect adherence to a web-based intervention. Methods We conducted a systematic review of studies into web-based health interventions. Per intervention, intervention characteristics, persuasive technology elements and adherence were coded. We performed a multiple regression analysis to investigate whether these variables could predict adherence. Results We included 101 articles on 83 interventions. The typical web-based intervention is meant to be used once a week, is modular in set-up, is updated once a week, lasts for 10 weeks, includes interaction with the system and a counselor and peers on the web, includes some persuasive technology elements, and about 50% of the participants adhere to the intervention. Regarding persuasive technology, we see that primary task support elements are most commonly employed (mean 2.9 out of a possible 7.0). Dialogue support and social support are less commonly employed (mean 1.5 and 1.2 out of a possible 7.0, respectively). When comparing the interventions of the different health care areas, we find significant differences in intended usage (p = .004), setup (p < .001), updates (p < .001), frequency of interaction with a counselor (p < .001), the system (p = .003) and peers (p = .017), duration (F = 6.068, p = .004), adherence (F = 4.833, p = .010) and the number of primary task support elements (F = 5.631, p = .005). Our final regression model explained 55% of the variance in adherence. In this model, a RCT study as opposed to an observational study, increased interaction with a counselor, more frequent intended usage, more frequent updates and more extensive employment of dialogue support significantly predicted better adherence. Conclusions Using intervention characteristics and persuasive technology elements, a substantial amount of variance in adherence can be explained. Although there are differences between health care areas on intervention characteristics, health care area per se does not predict adherence. Rather, the differences in technology and interaction predict adherence. The results of this study can be used to make an informed decision about how to design a web-based intervention to which patients are more likely to adhere.
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              Self-management education: History, definition, outcomes, and mechanisms

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                Author and article information

                Contributors
                +31 24 352 9148 , T.Pelle@maartenskliniek.nl , Tim.Pelle@radboudumc.nl
                K.Bevers@maartenskliniek.nl
                J.vanderPalen@mst.nl
                e.vandenende@maartenskliniek.nl
                Journal
                BMC Musculoskelet Disord
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central (London )
                1471-2474
                31 August 2019
                31 August 2019
                2019
                : 20
                : 398
                Affiliations
                [1 ]ISNI 0000 0004 0444 9307, GRID grid.452818.2, Department of Rheumatology, , Sint Maartenskliniek, ; Nijmegen, the Netherlands
                [2 ]ISNI 0000 0004 0444 9382, GRID grid.10417.33, Department of Rheumatology, , Radboud University Medical Center, ; Nijmegen, the Netherlands
                [3 ]ISNI 0000 0004 0399 8953, GRID grid.6214.1, Department of Research Methodology, Measurement, and Data-Analysis, Behavioural, Management and Social Sciences, , University of Twente, ; Enschede, The Netherlands
                [4 ]ISNI 0000 0004 0399 8347, GRID grid.415214.7, Medical School Twente, , Medisch Spectrum Twente, ; Enschede, the Netherlands
                Author information
                http://orcid.org/0000-0001-6862-5910
                Article
                2768
                10.1186/s12891-019-2768-9
                6717645
                31472687
                49ebb494-640b-43b5-b862-c757373ec576
                © The Author(s). 2019

                Open Access This article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 11 March 2019
                : 19 August 2019
                Funding
                Funded by: This project is funded within the INTERREG-programme and receives financial support by the European Union, the Ministry of Economic Affairs, Innovation, Digitalisation and Energy of the State of North Rhine-Westphalia, the Ministry of Economic Affairs and
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2019

                Orthopedics
                osteoarthritis,ehealth,knee and/or hip,oa,behavioural change techniques,chronic disease,machine learning

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