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

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Collaborators:

Information provided by (Responsible Party):

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Tracking Information

First Submitted Date ^ICMJE

August 10, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

August 20, 2018

Estimated Primary Completion Date

December 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Roland Morris Disability Questionnaire[ Time Frame: change from baseline to 6 weeks ]

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Pain intensity[ Time Frame: change from baseline to 6 weeks ]
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.
The Fear avoidance Belief Questionnaire[ Time Frame: change from baseline to 6 weeks ]
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]
Pain Self-Efficacy Questionnaire[ Time Frame: change from baseline to 6 weeks ]
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].
Activity limitation[ Time Frame: change from baseline to 6 weeks ]
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".
Workability[ Time Frame: change from baseline to 6 weeks ]
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].
Saltin-Grimby Physical Activity Level Scale[ Time Frame: change from baseline to 6 weeks ]
Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active
Patient Specific Functional Scale[ Time Frame: change from baseline to 6 weeks ]
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
Sleep[ Time Frame: change from baseline to 6 weeks ]
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.
Perceived Stress Scale[ Time Frame: change from baseline to 6 weeks ]
a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress
Health-related Quality of Life[ Time Frame: change from baseline to 6 weeks ]
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).
Brief Illness Perception Questionnaire[ Time Frame: change from baseline to 6 weeks ]
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].
Patient Health Questionnaire-8[ Time Frame: change from baseline to 6 weeks ]
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.
Patients Global Perceived effect[ Time Frame: 6 weeks ]
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
Patient Acceptable Symptom State[ Time Frame: 6 weeks. ]
a single item question on whether or not the patient considers their current symptom state as acceptable or not
Virtual Care Climate Questionnaire[ Time Frame: 6 weeks ]
The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting.
User ratings[ Time Frame: 6 weeks ]
Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief 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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention 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: Interventional
Masking Description:Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Other: Usual care + selfBACK
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.

Study Arms

Experimental: Usual care + selfBACK
Participants will use the selfBACK system and app

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2018

Estimated Primary Completion Date

December 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Denmark|Norway

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

University of Southern Denmark

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Karen Søgaard, PhD University of Southern Denmark

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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