Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 17, 2020
Date Accepted: Sep 22, 2020
Implementation and process evaluation of the app-delivered self-management intervention trial SELFBACK for people with low back pain. A protocol paper.
ABSTRACT
Background:
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. This paper presents the protocol for an implementation and process evaluation embedded in a multicentre randomized controlled trial conducted in Denmark and Norway (the SELFBACK project). SELFBACK is a data-driven decision support system, which provides participants with weekly self-management plans for low back pain. These plans are delivered through a smartphone application (app) and tailored to the individual participants by using case-based reasoning methodology. In the trial, we compare SELFBACK in addition to usual care with usual care alone.
Objective:
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 (RE-AIM) framework.
Methods:
We evaluate the process of implementing SELFBACK and investigate how participants uptake and utilise the intervention in daily life. The evaluation will also cover the reach of the intervention, healthcare providers’ willingness to adopt it, and participants’ satisfaction with the intervention. We gather quantitative measures by questionnaires and measures of data analytics on app usage, and perform a qualitative exploration of the implementation, using semi-structured interviews, theoretically informed by Normalisation Process Theory. The data collection is conducted between March 2019 to October 2020.
Results:
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.
Conclusions:
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 to other conditions and diseases where self-management is an essential prevention or treatment strategy. Clinical Trial: The trial was registered with www.clinicaltrials.gov (NCT03798288) on January 9th, 2019. https://www.clinicaltrials.gov/ct2/show/NCT03798288?term=NCT03798288&rank=1
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