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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Usual care + selfBACK


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Seeking care from primary health-care practice or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks LBP of any duration Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale. Age: ≥18 years Own and regularly use a smart phone (with at least Android 7.0 or iOS11.0) with internet access (Wi-Fi and/or mobile data) Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser. Exclusion Criteria: Not interested Unable to speak, read or write in the national language (Danish/ Norwegian) Cognitive impairment or learning disabilities Pathology, such as fracture, cancer, inflammatory diseases, and signs of radiculopathy (severe leg pain, loss of leg strength, or loss of or altered sensation in a myotomal or dermatomal distribution) Serious mental illness, such as major depression, schizophrenia, and psychosis Terminal illness Unable to take part in exercise/physical activity (such as non-ambulatory patients, use of walking aids/assistance, unable to get down and up from the floor independently) Fibromyalgia (diagnosed by a Health Care Professional) Pregnancy Previous back surgery Ongoing participation in other research trials for LBP management

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual care + selfBACK<br>Participants will use the selfBACK system and app | Other: Usual care + selfBACK<br>* The 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.<br>* Other names: selfBACK digital decision support system;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Morris Disability Questionnaire | The primary outcome is the Roland Morris Disability Questionnaire (RMDQ) assessing pain-related disability. The questionnaire includes 24 items asking participants to indicate if they experience functional impairments by answering yes or no to a series of descriptions of functional abilities with higher scores indicating higher level of disability. | change from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Pain intensity measured as average and worst within the past week. Measured on a 0 - 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable. Pain duration measures patients' selfreported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for low back pain. | change from baseline to 6 weeks | 
| The Fear avoidance Belief Questionnaire | The FABQ is a 5-item questionnaire, where the participants score their beliefs about their LBP on an ordinal scale ranging from zero [completely disagree] to six [completely agree] | change from baseline to 6 weeks | 
| Pain Self-Efficacy Questionnaire | The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain [52, 53]. The PSEQ is a 10-item questionnaire scored on an ordinal scale ranging from zero [completely disagree] to six [completely agree]. | change from baseline to 6 weeks | 
| Activity limitation | Activity Limitation evaluates if LBP has limited work and leisure time activities. The questionnaire consists of two single items with response options yes and no. | change from baseline to 6 weeks | 
| Workability | Work Ability is measured by a single-item and rated on an 11-point NRS scale ranging from zero [completely unable to work] to 10 [work ability at its best]. | change from baseline to 6 weeks | 
| Saltin-Grimby Physical Activity Level Scale | Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active | change from baseline to 6 weeks | 
| Patient Specific Functional Scale | Participants rate their function on up to two self-selected activities, are asked to rate if they are unable to do or are having difficulty with the their ability to perform self-selected activities regarded as important by the participants themselves | change from baseline to 6 weeks | 
| Sleep | Sleep is assessed by self-report using four items concerning problems with falling asleep, waking up repeatedly, waking up too early, and feeling sleepy during the day. | change from baseline to 6 weeks | 
| Perceived Stress Scale | a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress | change from baseline to 6 weeks | 
| Health-related Quality of Life | The EuroQoL 5-dimension (EQ-5D) questionnaire is used to asses quality of life within each of the five dimension (i.e., mobility, self-care, activities, pain/discomfort and anxiety/depression). | change from baseline to 6 weeks | 
| Brief Illness Perception Questionnaire | the questionnaire evaluates the participants' illness perception in an 8-item questionnaire. Items are scored on an ordinal scale ranging from zero [no problems] to 10 [worst severity]. | change from baseline to 6 weeks | 
| Patient Health Questionnaire-8 | the questionnaire is an 8-item questionnaire used to evaluate the participants' depressive symptoms. Items are scored on a 4-point Likert scale scoring frequency of experiencing symptoms of depression. | change from baseline to 6 weeks | 
| Patients Global Perceived effect | a single item question for Patient's Global Perceived Effect will be asked at follow-up, where participants are asked to rate improvement or deterioration of their LBP compared to before the intervention | 6 weeks | 
| Patient Acceptable Symptom State | a single item question on whether or not the patient considers their current symptom state as acceptable or not | 6 weeks. | 
| Virtual Care Climate Questionnaire | The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting. | 6 weeks | 
| User ratings | Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system | 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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App, Digital Decision Support System, Self-management