Clinical Trials Directory

Trials / Completed

CompletedNCT03697759

A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
51 (actual)
Sponsor
University of Southern Denmark · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The pilot study precedes a larger randomized controlled trial, to be starting in February 2019. In this pilot study all participants are allocated to the intervention group. The intervention consists of a digital decision support system delivering a weekly plan of suggested activities that the participant can use to self-manage their low back pain. The plan is presented to the participant in the selfBACK app.

Detailed description

The selfBACK intervention consists of the selfBACK system, that provides the participants with an individually tailored weekly plan of suggested activities to use in their self-management of low back pain. The SELFBACK system constitutes a data-driven predictive decision support system that uses Case-Based Reasoning methodology to capture and reuse participant cases in order to suggest the most suitable self-management plan for participants. The selfBACK system is an intelligent system that will adjust the suggested self-management plan to the individual participants by using the information available on the participant (baseline questionnaires), weekly self-reported of changes in health status through the app, and data on physical activity via the step-detecting wristband. The weekly plan includes three categories of content; 1) information/education, 2) physical activity monitoring through wearing a step-detecting wristband, and 3) strength and flexibility exercises.

Conditions

Interventions

TypeNameDescription
OTHERUsual care + selfBACKThe selfBACK intervention is a digital Decision Support System (DSS) for self-management of LBP provided to the participant via a smartphone app (selfBACK app). In addition, the participant is provided with a step-detecting wristband (Xiaomi Mi Band 2) that interacts with the selfBACK app. The DSS provides individually tailored self-management plans including content from three categories; 1) information/education, 2) physical activity monitoring through wearing the step-detecting wristband, and 3) strength and flexibility exercises. The weekly plans are individually tailored to the specific patient, using the data available from the patient, and each week the patients report back their progress on physical activity (step count) and exercise (volume completed). These data are matched with the patients follow-up data to create a self-management plan that is up to date and adaptable to variation in health-status of the individual patient.

Timeline

Start date
2018-08-20
Primary completion
2019-02-05
Completion
2019-02-17
First posted
2018-10-05
Last updated
2019-02-28

Locations

2 sites across 2 countries: Denmark, Norway

Source: ClinicalTrials.gov record NCT03697759. Inclusion in this directory is not an endorsement.