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App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.

ABSTRACT: BACKGROUND:Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all. OBJECTIVE:This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone app and tailored to individual participants by using case-based reasoning methodology. In the trial, we compare selfBACK in addition to usual care with usual care alone. METHODS:The aim of this study is to conduct a convergent mixed-methods implementation and process evaluation of the selfBACK app by following the reach, effectiveness, adoption, implementation, and maintenance framework. We will evaluate the process of implementing selfBACK and investigate how participants use the intervention in daily life. The evaluation will also cover the reach of the intervention, health care provider willingness to adopt it, and participant satisfaction with the intervention. We will gather quantitative measures by questionnaires and measures of data analytics on app use and perform a qualitative exploration of the implementation using semistructured interviews theoretically informed by normalization process theory. Data collection will be conducted between March 2019 and October 2020. RESULTS:The trial opened for recruitment in February 2019. This mixed-methods implementation and evaluation study is embedded in the randomized controlled trial and will be collecting data from March 2019 to October 2020; dissemination of trial results is planned thereafter. The results from the process evaluation are expected 2021-2022. CONCLUSIONS:This study will provide a detailed understanding of how self-management of low back pain can be improved and how a digital health intervention can be used as an add-on to usual care to support patients to self-manage their low back pain. We will provide knowledge that can be used to explore the possibilities of extending the generic components of the selfBACK system and key drivers that could be of use in other conditions and diseases where self-management is an essential prevention or treatment strategy. TRIAL REGISTRATION:ClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID):DERR1-10.2196/20308.

SUBMITTER: Rasmussen CDN

PROVIDER: S-EPMC7661240 | biostudies-literature | 2020 Oct

REPOSITORIES: biostudies-literature

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App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.

Rasmussen Charlotte Diana Nørregaard CDN Svendsen Malene Jagd MJ Wood Karen K Nicholl Barbara I BI Mair Frances S FS Sandal Louise Fleng LF Mork Paul Jarle PJ Søgaard Karen K Bach Kerstin K Stochkendahl Mette Jensen MJ

JMIR research protocols 20201029 10

<h4>Background</h4>Implementation and process evaluation is vital for understanding how interventions function in different settings, including if and why interventions have different effects or do not work at all.<h4>Objective</h4>This paper presents the protocol for an implementation and process evaluation embedded in a multicenter randomized controlled trial conducted in Denmark and Norway (the selfBACK project). selfBACK is a data-driven decision support system that provides participants wit ...[more]

PMID: 33118959

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Project description:BackgroundLow back pain (LBP) is prevalent across all social classes, in all age groups, and across industrialized and developing countries. From a global perspective, LBP is considered the leading cause of disability and negatively impacts everyday life and well-being. Self-management is a recommended first-line treatment, and mobile apps are a promising platform to support self-management of conditions like LBP. In the selfBACK project, we have developed a digital decision support system made available for the user via an app intended to support tailored self-management of nonspecific LBP.ObjectiveThe trial aims to evaluate the effectiveness of using the selfBACK app to support self-management in addition to usual care (intervention group) versus usual care only (control group) in people with nonspecific LBP.MethodsThis is a single-blinded, randomized controlled trial (RCT) with two parallel arms. The selfBACK app provides tailored self-management plans consisting of advice on physical activity, physical exercises, and educational content. Tailoring of plans is achieved by using case-based reasoning (CBR) methodology, which is a branch of artificial intelligence. The core of the CBR methodology is to use data about the current case (participant) along with knowledge about previous and similar cases to tailor the self-management plan to the current case. This enables a person-centered intervention based on what has and has not been successful in previous cases. Participants in the RCT are people with LBP who consulted a health care professional in primary care within the preceding 8 weeks. Participants are randomized to using the selfBACK app in addition to usual care versus usual care only. We aim to include a total of 350 participants (175 participants in each arm). Outcomes are collected at baseline, 6 weeks, and 3, 6, and 9 months. The primary end point is difference in pain-related disability between the intervention group and the control group assessed by the Roland-Morris Disability Questionnaire at 3 months.ResultsThe trial opened for recruitment in February 2019. Data collection is expected to be complete by fall 2020, and the results for the primary outcome are expected to be published in fall 2020.ConclusionsThis RCT will provide insights regarding the benefits of supporting tailored self-management of LBP through an app available at times convenient for the user. If successful, the intervention has the potential to become a model for the provision of tailored self-management support to people with nonspecific LBP and inform future interventions for other painful musculoskeletal conditions.Trial registrationClinicalTrial.gov NCT03798288; https://clinicaltrials.gov/ct2/show/NCT03798288.International registered report identifier (irrid)DERR1-10.2196/14720.

Project description:ImportanceLower back pain (LBP) is a prevalent and challenging condition in primary care. The effectiveness of an individually tailored self-management support tool delivered via a smartphone app has not been rigorously tested.ObjectiveTo investigate the effectiveness of selfBACK, an evidence-based, individually tailored self-management support system delivered through an app as an adjunct to usual care for adults with LBP-related disability.Design, setting, and participantsThis randomized clinical trial with an intention-to-treat data analysis enrolled eligible individuals who sought care for LBP in a primary care or an outpatient spine clinic in Denmark and Norway from March 8 to December 14, 2019. Participants were 18 years or older, had nonspecific LBP, scored 6 points or higher on the Roland-Morris Disability Questionnaire (RMDQ), and had a smartphone and access to email.InterventionsThe selfBACK app provided weekly recommendations for physical activity, strength and flexibility exercises, and daily educational messages. Self-management recommendations were tailored to participant characteristics and symptoms. Usual care included advice or treatment offered to participants by their clinician.Main outcomes and measuresPrimary outcome was the mean difference in RMDQ scores between the intervention group and control group at 3 months. Secondary outcomes included average and worst LBP intensity levels in the preceding week as measured on the numerical rating scale, ability to cope as assessed with the Pain Self-Efficacy Questionnaire, fear-avoidance belief as assessed by the Fear-Avoidance Beliefs Questionnaire, cognitive and emotional representations of illness as assessed by the Brief Illness Perception Questionnaire, health-related quality of life as assessed by the EuroQol-5 Dimension questionnaire, physical activity level as assessed by the Saltin-Grimby Physical Activity Level Scale, and overall improvement as assessed by the Global Perceived Effect scale. Outcomes were measured at baseline, 6 weeks, 3 months, 6 months, and 9 months.ResultsA total of 461 participants were included in the analysis; the population had a mean [SD] age of 47.5 [14.7] years and included 255 women (55%). Of these participants, 232 were randomized to the intervention group and 229 to the control group. By the 3-month follow-up, 399 participants (87%) had completed the trial. The adjusted mean difference in RMDQ score between the 2 groups at 3 months was 0.79 (95% CI, 0.06-1.51; P = .03), favoring the selfBACK intervention. The percentage of participants who reported a score improvement of at least 4 points on the RMDQ was 52% in the intervention group vs 39% in the control group (adjusted odds ratio, 1.76; 95% CI, 1.15-2.70; P = .01).Conclusions and relevanceAmong adults who sought care for LBP in a primary care or an outpatient spine clinic, those who used the selfBACK system as an adjunct to usual care had reduced pain-related disability at 3 months. The improvement in pain-related disability was small and of uncertain clinical significance. Process evaluation may provide insights into refining the selfBACK app to increase its effectiveness.Trial registrationClinicalTrials.gov Identifier: NCT03798288.

Project description:BackgroundClinical guidelines for nonspecific low back pain (LBP) recommend self-management tailored to individual needs and capabilities as a first-line treatment. Mobile health solutions are a promising method for delivering tailored self-management interventions to patients with nonspecific LBP. However, it is not clear if the effectiveness of such self-management interventions depends on patients' initial pain characteristics. High pain intensity and long-term symptoms of LBP have been associated with an unfavorable prognosis, and current best evidence indicates that long-term LBP (lasting more than 3 months) requires a more extensive treatment approach compared to more acute LBP. The artificial intelligence-based selfBACK app supports tailored and evidence-based self-management of nonspecific LBP. In a recent randomized controlled trial, we showed that individuals who received the selfBACK app in addition to usual care had lower LBP-related disability at the 3-month follow-up compared to those who received usual care only. This effect was sustained at 6 and 9 months.ObjectiveThis study aims to explore if the baseline duration and intensity of LBP influence the effectiveness of the selfBACK intervention in a secondary analysis of the selfBACK randomized controlled trial.MethodsIn the selfBACK trial, 461 adults (18 years or older) who sought care for nonspecific LBP in primary care or at an outpatient spine clinic were randomized to receive the selfBACK intervention adjunct to usual care (n=232) or usual care alone (n=229). In this secondary analysis, the participants were stratified according to the duration of the current LBP episode at baseline (≤12 weeks vs >12 weeks) or baseline LBP intensity (≤5 points vs >5 points) measured by a 0-10 numeric rating scale. The outcomes were LBP-related disability measured by the Roland-Morris Disability Questionnaire (0- to 24-point scale), average LBP intensity, pain self-efficacy, and global perceived effect. To assess whether the duration and intensity of LBP influenced the effect of selfBACK, we estimated the difference in treatment effect between the strata at the 3- and 9-month follow-ups with a 95% CI.ResultsOverall, there was no difference in effect for patients with different durations or intensities of LBP at either the 3- or 9-month follow-ups. However, there was suggestive evidence that the effect of the selfBACK intervention on LBP-related disability at the 3-month follow-up was largely confined to people with the highest versus the lowest LBP intensity (mean difference between the intervention and control group -1.8, 95% CI -3.0 to -0.7 vs 0.2, 95% CI -1.1 to 0.7), but this was not sustained at the 9-month follow-up.ConclusionsThe results suggest that the intensity and duration of LBP have negligible influence on the effectiveness of the selfBACK intervention on LBP-related disability, average LBP intensity, pain self-efficacy, and global perceived effect.

Project description:BackgroundSelf-management is the key recommendation for managing nonspecific low back pain (LBP). However, there are well-documented barriers to self-management; therefore, methods of facilitating adherence are required. Smartphone apps are increasingly being used to support self-management of long-term conditions such as LBP.ObjectiveThe aim of this study was to assess the usability and acceptability of the SELFBACK smartphone app, designed to support and facilitate self-management of non-specific LBP. The app provides weekly self-management plans, comprising physical activity, strength and flexibility exercises, and patient education. The plans are tailored to the patient's characteristics and symptom progress by using case-based reasoning methodology.MethodsThe study was carried out in 2 stages using a mixed-methods approach. All participants undertook surveys, and semistructured telephone interviews were conducted with a subgroup of participants. Stage 1 assessed an app version with only the physical activity component and a web questionnaire that collects information necessary for tailoring the self-management plans. The physical activity component included monitoring of steps recorded by a wristband, goal setting, and a scheme for sending personalized, timely, and motivational notifications to the user's smartphone. Findings from Stage 1 were used to refine the app and inform further development. Stage 2 investigated an app version that incorporated 3 self-management components (physical activity, exercises, and education). A total of 16 participants (age range 23-71 years) with ongoing or chronic nonspecific LBP were included in Stage 1, and 11 participants (age range 32-56 years) were included in Stage 2.ResultsIn Stage 1, 15 of 16 participants reported that the baseline questionnaire was easy to answer, and 84% (13/16) found the completion time to be acceptable. Overall, participants were positive about the usability of the physical activity component but only 31% (5/16) found the app functions to be well integrated. Of the participants, 90% (14/16) were satisfied with the notifications, and they were perceived as being personalized (12/16, 80%). In Stage 2, all participants reported that the web questionnaire was easy to answer and the completion time acceptable. The physical activity and exercise components were rated useful by 80% (8/10), while 60% (6/10) rated the educational component useful. Overall, participants were satisfied with the usability of the app; however, only 50% (5/10) found the functions to be well integrated, and 20% (2/10) found them to be inconsistent. Overall, 80% (8/10) of participants reported it to be useful for self-management. The interviews largely reinforced the survey findings in both stages.ConclusionsThis study has demonstrated that participants considered the SELFBACK app to be acceptable and usable and that they thought it would be useful for supporting self-management of LBP. However, we identified some limitations and suggestions useful to guide further development of the SELFBACK app and other mobile health interventions.

Project description:BackgroundInternational guidelines consistently endorse the promotion of self-management for people with low back pain (LBP); however, implementation of these guidelines remains a challenge. Digital health interventions, such as those that can be provided by smartphone apps, have been proposed as a promising mode of supporting self-management in people with chronic conditions, including LBP. However, the evidence base for digital health interventions to support self-management of LBP is weak, and detailed descriptions and documentation of the interventions are lacking. Structured intervention mapping (IM) constitutes a 6-step process that can be used to guide the development of complex interventions.ObjectiveThe aim of this paper is to describe the IM process for designing and creating an app-based intervention designed to support self-management of nonspecific LBP to reduce pain-related disability.MethodsThe first 5 steps of the IM process were systematically applied. The core processes included literature reviews, brainstorming and group discussions, and the inclusion of stakeholders and representatives from the target population. Over a period of >2 years, the intervention content and the technical features of delivery were created, tested, and revised through user tests, feasibility studies, and a pilot study.ResultsA behavioral outcome was identified as a proxy for reaching the overall program goal, that is, increased use of evidence-based self-management strategies. Physical exercises, education, and physical activity were the main components of the self-management intervention and were designed and produced to be delivered via a smartphone app. All intervention content was theoretically underpinned by the behavior change theory and the normalization process theory.ConclusionsWe describe a detailed example of the application of the IM approach for the development of a theory-driven, complex, and digital intervention designed to support self-management of LBP. This description provides transparency in the developmental process of the intervention and can be a possible blueprint for designing and creating future digital health interventions for self-management.

Project description:IntroductionLow back pain (LBP) and neck pain (NP) are common and costly conditions. Self-management is a key element in the care of persistent LBP and NP. Artificial intelligence can be used to support and tailor self-management interventions, but their effectiveness needs to be ascertained. The aims of this trial are (1) to evaluate the effectiveness of an individually tailored app-based self-management intervention (selfBACK) adjunct to usual care in people with LBP and/or NP in secondary care compared with usual care only, and (2) to compare the effectiveness of selfBACK with a web-based self-management intervention without individual tailoring (e-Help).Methods and analysisThis is a randomised, assessor-blind clinical trial with three parallel arms: (1) selfBACK app adjunct to usual care; (2) e-Help website adjunct to usual care and (3) usual care only. Patients referred to St Olavs Hospital, Trondheim (Norway) with LBP and/or NP and accepted for assessment/treatment at the multidisciplinary outpatient clinic for back or neck rehabilitation are invited to the study. Eligible and consenting participants are randomised to one of the three arms with equal allocation ratio. We aim to include 279 participants (93 in each arm). Outcome variables are assessed at baseline (before randomisation) and at 6-week, 3-month and 6-month follow-up. The primary outcome is musculoskeletal health measured by the Musculoskeletal Health Questionnaire at 3 months. A mixed-methods process evaluation will document patients' and clinicians' experiences with the interventions. A health economic evaluation will estimate the cost-effectiveness of both interventions' adjunct to usual care.Ethics and disseminationThe trial is approved by the Regional Committee for Medical and Health Research Ethics in Central Norway (Ref. 2019/64084). The results of the trial will be published in peer-review journals and presentations at national and international conferences relevant to this topic.Trial registration numberNCT04463043.

Project description:BackgroundLow back pain (LBP) is one of the most common reasons for disability globally. Digital interventions are a promising means of supporting people to self-manage LBP, but implementation of digital interventions has been suboptimal. An artificial intelligence-driven app, selfBACK, was developed to support self-management of LBP as an adjunct to usual care. To better understand the process of implementation from a participant perspective, we qualitatively explored factors influencing embedding, integrating, and sustaining engagement with the selfBACK app, and the self-perceived effects, acceptability, and satisfaction with the selfBACK app.MethodsUsing a qualitative interview study and an analytic framework approach underpinned by Normalization Process Theory (NPT), we investigated the experiences of patients who participated in the selfBACK randomized controlled trial (RCT). Interviews focused on the motivation to participate in the RCT, experiences of using the selfBACK app, and views about future intended use and potential of using digital health interventions for self-management of LBP. Participants were purposively sampled to represent diversity in age, sex, and implementation reflected by a proxy measure of number of app-generated self-management plans during the first three months of RCT participation.ResultsTwenty-six participants aged 21-78, eleven females and fifteen men, with two to fourteen self-management plans, were interviewed between August 2019 and April 2020. A broad range of factors influencing implementation of selfBACK within all constructs of NPT were identified. Key facilitating factors were preferences and beliefs favoring self-management, a friendly, motivational, and reassuring supporter, tailoring and personalization, convenience and ease of use, trustworthiness, perceiving benefits, and tracking achievements. Key impeding factors were preferences and beliefs not favoring self-management, functionality issues, suboptimal tailoring and personalization, insufficient time or conflicting life circumstances, not perceiving benefits, and insufficient involvement of health care practitioners. Self-perceived effects on pain and health, behavior/attitude, and gaining useful knowledge varied by participant.ConclusionsThe high prevalence of LBP globally coupled with the advantages of providing help through an app offers opportunities to help countless people. A range of factors should be considered to facilitate implementation of self-management of LBP or similar pain conditions using digital health tools.

Project description:BackgroundSELFBACK, an artificial intelligence (AI)-based app delivering evidence-based tailored self-management support to people with low back pain (LBP), has been shown to reduce LBP-related disability when added to usual care. LBP commonly co-occurs with multimorbidity (≥ 2 long-term conditions) or pain at other musculoskeletal sites, so this study explores if these factors modify the effect of the SELFBACK app or influence outcome trajectories over time.MethodsSecondary analysis of a randomized controlled trial with 9-month follow-up. Primary outcome is as follows: LBP-related disability (Roland Morris Disability Questionnaire, RMDQ). Secondary outcomes are as follows: stress/depression/illness perception/self-efficacy/general health/quality of life/physical activity/global perceived effect. We used linear mixed models for continuous outcomes and logistic generalized estimating equation for binary outcomes. Analyses were stratified to assess effect modification, whereas control (n = 229) and intervention (n = 232) groups were pooled in analyses of outcome trajectories.ResultsBaseline multimorbidity and co-occurring musculoskeletal pain sites did not modify the effect of the SELFBACK app. The effect was somewhat stronger in people with multimorbidity than among those with LBP only (difference in RMDQ due to interaction, - 0.9[95 % CI - 2.5 to 0.6]). Participants with a greater number of long-term conditions and more co-occurring musculoskeletal pain had higher levels of baseline disability (RMDQ 11.3 for ≥ 2 long-term conditions vs 9.5 for LBP only; 11.3 for ≥ 4 musculoskeletal pain sites vs 10.2 for ≤ 1 additional musculoskeletal pain site); along with higher baseline scores for stress/depression/illness perception and poorer pain self-efficacy/general health ratings. In the pooled sample, LBP-related disability improved slightly less over time for people with ≥ 2 long-term conditions additional to LBP compared to no multimorbidity and for those with ≥4 co-occurring musculoskeletal pain sites compared to ≤ 1 additional musculoskeletal pain site (difference in mean change at 9 months = 1.5 and 2.2, respectively). All groups reported little improvement in secondary outcomes over time.ConclusionsMultimorbidity or co-occurring musculoskeletal pain does not modify the effect of the selfBACK app on LBP-related disability or other secondary outcomes. Although people with these health problems have worse scores both at baseline and 9 months, the AI-based selfBACK app appears to be helpful for those with multimorbidity or co-occurring musculoskeletal pain.Trial registrationNCT03798288 . Date of registration: 9 January 2019.

Project description:BackgroundLow back pain (LBP) is a leading cause of disability worldwide. Most patients with LBP encountered in primary care settings have nonspecific LBP, that is, pain with an unknown pathoanatomical cause. Self-management in the form of physical activity and strength and flexibility exercises along with patient education constitute the core components of the management of nonspecific LBP. However, the adherence to a self-management program is challenging for most patients, especially without feedback and reinforcement. Here we outline a protocol for the design and implementation of a decision support system (DSS), selfBACK, to be used by patients themselves to promote self-management of LBP.ObjectiveThe main objective of the selfBACK project is to improve self-management of nonspecific LBP to prevent chronicity, recurrence and pain-related disability. This is achieved by utilizing computer technology to develop personalized self-management plans based on individual patient data.MethodsThe decision support is conveyed to patients via a mobile phone app in the form of advice for self-management. Case-based reasoning (CBR), a technology that utilizes knowledge about previous cases along with data about the current patient case, is used to tailor the advice to the current patient, enabling a patient-centered intervention based on what has and has not been successful in previous patient cases. The data source for the CBR system comprises initial patient data collected by a Web-based questionnaire, weekly patient reports (eg, symptom progression), and a physical activity-detecting wristband. The effectiveness of the selfBACK DSS will be evaluated in a multinational, randomized controlled trial (RCT), targeting care-seeking patients with nonspecific LBP. A process evaluation will be carried out as an integral part of the RCT to document the implementation and patient experiences with selfBACK.ResultsThe selfBACK project was launched in January 2016 and will run until the end of 2020. The final version of the selfBACK DSS will be completed in 2018. The RCT will commence in February 2019 with pain-related disability at 3 months as the primary outcome. The trial results will be reported according to the CONSORT statement and the extended CONSORT-EHEALTH checklist. Exploitation of the results will be ongoing throughout the project period based on a business plan developed by the selfBACK consortium. Tailored digital support has been proposed as a promising approach to improve self-management of chronic disease. However, tailoring self-management advice according to the needs, motivation, symptoms, and progress of individual patients is a challenging task. Here we outline a protocol for the design and implementation of a stand-alone DSS based on the CBR technology with the potential to improve self-management of nonspecific LBP.ConclusionsThe selfBACK project will provide learning regarding the implementation and effectiveness of an app-based DSS for patients with nonspecific LBP.Registered report identifierRR1-10.2196/9379.

Dataset Information

App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.

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App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation.

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