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| ID | Type | Description | Link |
|---|---|---|---|
| 2018/791 | Other Identifier | The Regional Committee for Medicine and Health Related Research Ethics |
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| Name | Class |
|---|---|
| Norwegian University of Science and Technology | OTHER |
| National Research Centre for the Working Environment, Denmark | OTHER_GOV |
| University of Glasgow | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + selfBACK | Experimental | Participants will use the selfBACK system and app |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Usual care + selfBACK | Other | 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. |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Tailoring variables | Participants in the intervention are on a weekly basis asked a set of tailoring questions. These are tracked over the intervention period. The tailoring questions include items on pain (NRS for pain intensity), function, fear-avoidance, work ability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management. Note. not all questions are asked on a weekly basis |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Karen Søgaard, PhD | University of Southern Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark | Odense | 5230 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Bach K, Szczepanski T, Aamodt A, Gundersen OE, Mork. PJ. Case Representation and Similarity Assessment in the selfBACK Decision Support System ICCBR 2016: Case-Based Reasoning Research and Development pp 32-46 | ||
| 32489674 | Derived | Sandal LF, Overas CK, Nordstoga AL, Wood K, Bach K, Hartvigsen J, Sogaard K, Mork PJ. A digital decision support system (selfBACK) for improved self-management of low back pain: a pilot study with 6-week follow-up. Pilot Feasibility Stud. 2020 May 23;6:72. doi: 10.1186/s40814-020-00604-2. eCollection 2020. |
| Label | URL |
|---|---|
| project webpage | View source |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D000544 | Alzheimer Disease |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| Robert Gordon University |
| OTHER |
This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.
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Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.
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| 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 |
| Weekly for 6 weeks |
| Physical activity | The patients' weekly recommended step count goal, and the actual achieved step count per. day | weekly for 6 weeks |
| Exercise volume | The patients report back their completed exercise volume as number of set and repetitions for their suggested exercises, when they perform them | weekly for 6 weeks |
| Norwegian University of Science and Techonology | Trondheim | Norway |
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003704 | Dementia |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D024801 | Tauopathies |
| D019636 | Neurodegenerative Diseases |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |