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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 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 (LBP) via an smartphone 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 decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants.
The weekly plan includes three categories of content;
Outcomes are collected as baseline, 6 weeks, 3, 6, 9 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Usual care + selfBACK | Experimental | The selfBACK system constitutes a data-driven decision support system that uses case-based reasoning to capture and reuse participant cases to suggest the most suitable self-management plan for participants. The system is an intelligent system delivering self-management plans tailored to individual participant characteristics. Information about participant characteristics is collected via a (baseline) questionnaire, weekly self-reports via the app on symptom progression etc., and a wristband that detect daily number of steps. The weekly plans are presented in an app to participants. The weekly plan includes three categories of content;
|
|
| Usual care | Active Comparator | Any diagnostic or treatment-related pathway (e.g. receive information, advice or treatment) as instructed by their health care professional. Patients are allowed to seek care, treatment or help elsewhere as normal. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| selfBACK | Behavioral | Participants will use the selfBACK system and app in addition to receiving usual care |
|
| 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 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Self-Efficacy Questionnaire | The questionnaire assesses the participant's level of confidence in carrying out specific activities despite their pain. 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 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Workability | Workability 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 3 months |
| Health-related Quality of Life |
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 |
|---|---|---|---|
| 30030208 | Background | Mork PJ, Bach K; selfBACK Consortium. A Decision Support System to Enhance Self-Management of Low Back Pain: Protocol for the selfBACK Project. JMIR Res Protoc. 2018 Jul 20;7(7):e167. doi: 10.2196/resprot.9379. | |
| 39242164 | Derived | Kongstad LP, Overas CK, Skovsgaard CV, Sandal LF, Hartvigsen J, Sogaard K, Mork PJ, Stochkendahl MJ. Cost-effectiveness analysis of app-delivered self-management support (selfBACK) in addition to usual care for people with low back pain in Denmark. BMJ Open. 2024 Sep 5;14(9):e086800. doi: 10.1136/bmjopen-2024-086800. |
| Label | URL |
|---|---|
| project webpage | View source |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 20, 2019 | Mar 4, 2019 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 8, 2023 | Feb 14, 2023 | SAP_002.pdf |
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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 |
The study design is a multi-center randomised controlled trial with 2 parallel arms
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The analysis of the data will be performed blindly.
| Usual care | Other | Participants will receive usual care |
|
| 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 3 months |
| Pain intensity | Pain intensity measured as average and worst LBP within the past week. Measured on a 0 - 10 Numerical Rating Scale with 0 being no pain and 10 being worst pain imaginable. | change from baseline to 3 months |
| 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 3 months |
| 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 3 months |
| 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 | 3 months |
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 3 months |
| 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 3 months |
| 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 3 months |
| Perceived Stress Scale | a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress | change from baseline to 3 months |
| 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 3 months |
| 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 3 months |
| Pain duration and frequency | Pain duration measures patients' self-reported length of current pain episode. Pain medication measures the frequency of the non-prescription pain medication use for LBP. | change from baseline to 3 months |
| Virtual Care Climate Questionnaire | The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting. | 4 months |
| User ratings | Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system | 4 months |
| 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 lob back pain (NRS for pain intensity), function, fear-avoidance, workability, sleep, pain self-efficacy, stress, symptoms of depression, and barriers for self-management. Note. not all questions are asked on a weekly basis | weekly for 9 months |
| Physical activity | The patients' weekly recommended step count goal, and the actual achieved step count per. day | weekly for 9 months |
| Exercise volume | The patients report back their completed exercise volume as number of sets and repetitions for their suggested exercises, when they perform them | weekly for 9 months |
| Norwegian University of Science and Technology | Trondheim | Norway |
| 37738237 | Derived | Bardal EM, Sandal LF, Nilsen TIL, Nicholl BI, Mork PJ, Sogaard K. Do age, gender, and education modify the effectiveness of app-delivered and tailored self-management support among adults with low back pain?-Secondary analysis of the selfBACK randomised controlled trial. PLOS Digit Health. 2023 Sep 22;2(9):e0000302. doi: 10.1371/journal.pdig.0000302. eCollection 2023 Sep. |
| 36192724 | Derived | Svendsen MJ, Nicholl BI, Mair FS, Wood K, Rasmussen CDN, Stochkendahl MJ. One size does not fit all: Participants' experiences of the selfBACK app to support self-management of low back pain-a qualitative interview study. Chiropr Man Therap. 2022 Oct 3;30(1):41. doi: 10.1186/s12998-022-00452-2. |
| 35130898 | Derived | Overas CK, Nilsen TIL, Nicholl BI, Rughani G, Wood K, Sogaard K, Mair FS, Hartvigsen J. Multimorbidity and co-occurring musculoskeletal pain do not modify the effect of the SELFBACK app on low back pain-related disability. BMC Med. 2022 Feb 8;20(1):53. doi: 10.1186/s12916-022-02237-z. |
| 34338710 | Derived | Sandal LF, Bach K, Overas CK, Svendsen MJ, Dalager T, Stejnicher Drongstrup Jensen J, Kongsvold A, Nordstoga AL, Bardal EM, Ashikhmin I, Wood K, Rasmussen CDN, Stochkendahl MJ, Nicholl BI, Wiratunga N, Cooper K, Hartvigsen J, Kjaer P, Sjogaard G, Nilsen TIL, Mair FS, Sogaard K, Mork PJ. Effectiveness of App-Delivered, Tailored Self-management Support for Adults With Lower Back Pain-Related Disability: A selfBACK Randomized Clinical Trial. JAMA Intern Med. 2021 Oct 1;181(10):1288-1296. doi: 10.1001/jamainternmed.2021.4097. |
| 33118959 | Derived | Rasmussen CDN, Svendsen MJ, Wood K, Nicholl BI, Mair FS, Sandal LF, Mork PJ, Sogaard K, Bach K, Stochkendahl MJ. App-Delivered Self-Management Intervention Trial selfBACK for People With Low Back Pain: Protocol for Implementation and Process Evaluation. JMIR Res Protoc. 2020 Oct 29;9(10):e20308. doi: 10.2196/20308. |
| 31793897 | Derived | Sandal LF, Stochkendahl MJ, Svendsen MJ, Wood K, Overas CK, Nordstoga AL, Villumsen M, Rasmussen CDN, Nicholl B, Cooper K, Kjaer P, Mair FS, Sjogaard G, Nilsen TIL, Hartvigsen J, Bach K, Mork PJ, Sogaard K. An App-Delivered Self-Management Program for People With Low Back Pain: Protocol for the selfBACK Randomized Controlled Trial. JMIR Res Protoc. 2019 Dec 3;8(12):e14720. doi: 10.2196/14720. |
| 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 |