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

Charlotte Diana Nørregaard Rasmussen, Malene Jagd Svendsen, Karen Wood, Barbara I Nicholl, Frances S Mair, Louise Fleng Sandal, Paul Jarle Mork, Karen Søgaard, Kerstin Bach, Mette Jensen Stochkendahl, Charlotte Diana Nørregaard Rasmussen, Malene Jagd Svendsen, Karen Wood, Barbara I Nicholl, Frances S Mair, Louise Fleng Sandal, Paul Jarle Mork, Karen Søgaard, Kerstin Bach, Mette Jensen Stochkendahl

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.

Keywords: RE-AIM; decision support system; digital health intervention; implementation; low back pain; mHealth; process evaluation; randomized controlled trial.

Conflict of interest statement

Conflicts of Interest: The overall aim of the selfBACK project is to develop a digital decision support system and mobile app to support participants to self-manage their low back pain. The results and experiences from the pilot and RCT will inform the further development of the selfBACK system, which may be introduced into the commercial market. If the selfBACK system is introduced into the commercial market, it will be done by a separate company that will have obtained a license to take the app to market. Any profit from such a transaction is received by the participating universities and not by individual authors. In order to secure an unbiased interpretation and dissemination of the RCT, the interpretation of the results will be performed blind to group allocation. Upon publication of study results, this commercial potential in the app development will be clearly stated and the publication will undergo peer review to ensure methodological and scientific rigor. Additionally, the overall conduct of the trial is overseen with a semiannual review by the European Union, which is funding the project.

©Charlotte Diana Nørregaard Rasmussen, Malene Jagd Svendsen, Karen Wood, Barbara I Nicholl, Frances S Mair, Louise Fleng Sandal, Paul Jarle Mork, Karen Søgaard, Kerstin Bach, Mette Jensen Stochkendahl. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 29.10.2020.

Figures

Figure 1
Figure 1
Four constructs of normalization process theory and associated questions from the process evaluation.

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