An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

Sandal, Louise Fleng; Stochkendahl, Mette Jensen; Svendsen, Malene Jagd; Wood, Karen; Øverås, Cecilie K; Nordstoga, Anne Lovise; Villumsen, Morten; Rasmussen, Charlotte Diana Nørregaard; Nicholl, Barbara I; Cooper, Kay; Kjær, Per; Mair, Frances S; Sjøgaard, Gisela; Nilsen, Tom Ivar Lund; Hartvigsen, Jan; Bach, Kerstin; Mork, Paul Jarle; Søgaard, Karen

doi:10.2196/14720

Cited by 40 publications

(58 citation statements)

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“…The app content builds on clinical guidelines for treatment of low back pain and has three main components: (1) physical activity advice and step counting using input from an activity-detecting wristband, (2) education based on a cognitive behavioral approach, and (3) instructions on physical strength and flexibility exercises. The content of the app used is described in detail in the protocol paper [ 21 - 23 ]. Tailoring of the self-management plans is achieved by using the case-based reasoning methodology, which is an artificial intelligence method.…”

Section: Methodsmentioning

confidence: 99%

“…The intervention arm will use the selfBACK app in addition to usual care. The trial will include 350 participants allocated 1:1 to the usual care arm and intervention arm (selfBACK as an add-on to usual care) [ 21 - 23 ]. Eligible participants for the RCT are individuals who seek care from a primary health care practice or an outpatient hospital facility for nonspecific low back pain.…”

Section: Methodsmentioning

confidence: 99%

“…The focus of this paper is the planned evaluation of the implementation processes. A detailed protocol concerning the design of the RCT and a feasibility study have been reported elsewhere [ 23 , 24 ]. Results of the pilot study will be reported separately.…”

Section: Introductionmentioning

confidence: 99%

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

Rasmussen¹,

Svendsen²,

Wood³

et al. 2020

JMIR Res Protoc

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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

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Section: Methodsmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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

Rasmussen¹,

Svendsen²,

Wood³

et al. 2020

JMIR Res Protoc

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“…The flow of the participants throughout the study is shown in Fig. 2 and described in detail elsewhere [19]. People with LBP could be referred to the pilot study after seeing a primary care clinician (i.e., general practitioner, physiotherapist, chiropractor).…”

Section: Recruitment Proceduresmentioning

confidence: 99%

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up

Sandal

Øverås

Nordstoga

et al. 2020

Pilot Feasibility Stud

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Background: Very few of the publicly available apps directed towards self-management of low back pain (LBP) have been rigorously tested and their theoretical underpinnings seldom described. The selfBACK app was developed in collaboration with end-users and clinicians and its content is supported by best evidence on selfmanagement of LBP. The objectives of this pilot study were to investigate the basis for recruitment and screening procedures for the subsequent randomized controlled trial (RCT), to test the inclusion process in relation to questionnaires and app installation, and finally to investigate the change in primary outcome over time. Methods: This single-armed pilot study enrolled 51 participants who had sought help for LBP of any duration from primary care (physiotherapy, chiropractic, or general practice) within the past 8 weeks. Participants were screened for eligibility using the PROMIS-Physical-Function-4a questionnaire. Participants were asked to use the selfBACK app for 6 weeks. The app provided weekly tailored self-management plans targeting physical activity, strength and flexibility exercises, and education. The construction of the self-management plans was achieved using case-based reasoning (CBR) methodology to capture and reuse information from previous successful cases. Participants completed the primary outcome pain-related disability (Roland-Morris Disability Questionnaire [RMDQ]) at baseline and 6-week follow-up along with a range of secondary outcomes. Metrics of app use were collected throughout the intervention period. Results: Follow-up data at 6 weeks was obtained for 43 participants. The recruitment procedures were feasible, and the number needed to screen was acceptable (i.e., 1.6:1). The screening questionnaire was altered during the pilot study. The inclusion process, answering questionnaires and app installation, were feasible. The primary outcome (RMDQ) improved from 8.6 (SD 5.1) at baseline to 5.9 (SD 4.0) at 6-week follow-up (change score 1.8, 95% CI 0.7 to 2.9). Participants spent on average 134 min (range 0-889 min) using the app during the 6-week period.

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“…11 An ongoing European programme of work seeks to determine the effectiveness of a mobile app-based digital decision support self-management programme (selfBACK) for patients recently consulting in primary care for LBP. 12 While mobile apps show potential, internet interventions likely have an accessibility advantage; they can be accessed from any device with an internet connection (eg, desktop, laptop, tablet, mobile phone).…”

Section: Introductionmentioning

confidence: 99%

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

et al. 2020

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IntroductionSelf-management and remaining physically active are first-line recommendations for the care of patients with low back pain (LBP). With a lifetime prevalence of up to 85%, novel approaches to support behavioural self-management are needed. Internet interventions may provide accessible support for self-management of LBP in primary care. The aim of this randomised controlled trial is to determine the clinical and cost-effectiveness of the ‘SupportBack’ internet intervention, with or without physiotherapist telephone support in reducing LBP-related disability in primary care patients.Methods and analysisA three-parallel arm, multicentre randomised controlled trial will compare three arms: (1) usual primary care for LBP; (2) usual primary care for LBP and an internet intervention; (3) usual primary care for LBP and an internet intervention with additional physiotherapist telephone support. Patients with current LBP and no indicators of serious spinal pathology are identified and invited via general practice list searches and mailouts or opportunistic recruitment following LBP consultations. Participants undergo a secondary screen for possible serious spinal pathology and are then asked to complete baseline measures online after which they are randomised to an intervention arm. Follow-ups occur at 6 weeks, 3, 6 and 12 months. The primary outcome is physical function (using the Roland and Morris Disability Questionnaire) over 12 months (repeated measures design). Secondary outcomes include pain intensity, troublesome days in pain over the last month, pain self-efficacy, catastrophising, kinesophobia, health-related quality of life and cost-related measures for a full health economic analysis. A full mixed-methods process evaluation will be conducted.Ethics and disseminationThis trial has been approved by a National Health Service Research Ethics Committee (REC Ref: 18/SC/0388). Results will be disseminated through peer-reviewed journals, conferences, communication with practices and patient groups. Patient representatives will support the implementation of our full dissemination strategy.Trial registration numberISRCTN14736486.

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An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial

Cited by 40 publications

References 61 publications

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

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

A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up

Supporting self-management of low back pain with an internet intervention in primary care: a protocol for a randomised controlled trial of clinical and cost-effectiveness (SupportBack 2)

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