Abstract
BackgroundImplementation 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.ObjectiveThis 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.MethodsThe 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.ResultsThe 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.ConclusionsThis 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 RegistrationClinicalTrials.gov NCT03798288; https://www.clinicaltrials.gov/ct2/show/NCT03798288International Registered Report Identifier (IRRID)DERR1-10.2196/20308
Highlights
Self-management is often recommended as an important element of living with a chronic health condition
With the increased integration of digital technologies in our daily lives, digital health interventions such as smartphone apps have been suggested as promising platforms for supporting self-management [3,4], and they are increasingly being used to help people manage their chronic conditions [5]
Digital health interventions may encourage patients to engage in preventive health activities, promote communication between health care providers and patients, and improve patient adherence to treatment protocols and self-care of chronic conditions [6]
Summary
Self-management is often recommended as an important element of living with a chronic health condition. We need to enhance our understanding of factors that hinder or promote uptake and use of digital health interventions, especially for individual conditions [6]. To gain this knowledge, systematic evaluations of implementation processes are vital for investigating how participants engage with and use digital health interventions in daily life. Systematic evaluations of implementation processes are vital for investigating how participants engage with and use digital health interventions in daily life These evaluations consist of multiple components, which together can help distinguish between interventions that are inherently faulty (failure of intervention concept or theory) and those that are poorly delivered (implementation failure) [8]. 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
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