Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2026-01-22 @ 8:06 PM
Study NCT ID:
NCT03697759
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2018-08-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}, {'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D001416', 'term': 'Back Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Since there is no randomization, all participants receive the intervention. Consequently, there is no blinding.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a pilot study preceding a randomized controlled trial. In the pilot study all enrolled participants are offered the intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-08-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2019-02-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-27', 'studyFirstSubmitDate': '2018-08-10', 'studyFirstSubmitQcDate': '2018-10-04', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-10-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Tailoring variables', 'timeFrame': 'Weekly for 6 weeks', 'description': '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.\n\nNote. not all questions are asked on a weekly basis'}, {'measure': 'Physical activity', 'timeFrame': 'weekly for 6 weeks', 'description': "The patients' weekly recommended step count goal, and the actual achieved step count per. day"}, {'measure': 'Exercise volume', 'timeFrame': 'weekly for 6 weeks', 'description': 'The patients report back their completed exercise volume as number of set and repetitions for their suggested exercises, when they perform them'}], 'primaryOutcomes': [{'measure': 'Roland Morris Disability Questionnaire', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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.'}], 'secondaryOutcomes': [{'measure': 'Pain intensity', 'timeFrame': 'change from baseline to 6 weeks', 'description': "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.\n\nPain 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."}, {'measure': 'The Fear avoidance Belief Questionnaire', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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\\]'}, {'measure': 'Pain Self-Efficacy Questionnaire', 'timeFrame': 'change from baseline to 6 weeks', 'description': "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\\]."}, {'measure': 'Activity limitation', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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".'}, {'measure': 'Workability', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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\\].'}, {'measure': 'Saltin-Grimby Physical Activity Level Scale', 'timeFrame': 'change from baseline to 6 weeks', 'description': 'Participants indicate their amount of time per week performing leisure activities with four levels of intensity ranging from sedentary to vigorous physically active'}, {'measure': 'Patient Specific Functional Scale', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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'}, {'measure': 'Sleep', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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.'}, {'measure': 'Perceived Stress Scale', 'timeFrame': 'change from baseline to 6 weeks', 'description': 'a 10-item questionnaire asking about frequency of thoughts and feelings related to perceived stress'}, {'measure': 'Health-related Quality of Life', 'timeFrame': 'change from baseline to 6 weeks', 'description': '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).'}, {'measure': 'Brief Illness Perception Questionnaire', 'timeFrame': 'change from baseline to 6 weeks', 'description': "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\\]."}, {'measure': 'Patient Health Questionnaire-8', 'timeFrame': 'change from baseline to 6 weeks', 'description': "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."}, {'measure': 'Patients Global Perceived effect', 'timeFrame': '6 weeks', 'description': "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"}, {'measure': 'Patient Acceptable Symptom State', 'timeFrame': '6 weeks.', 'description': 'a single item question on whether or not the patient considers their current symptom state as acceptable or not'}, {'measure': 'Virtual Care Climate Questionnaire', 'timeFrame': '6 weeks', 'description': "The Virtual Care Climate Questionnaire concerns patients' perceived support for autonomy in a virtual care setting."}, {'measure': 'User ratings', 'timeFrame': '6 weeks', 'description': 'Three rating questions on overall rating, ease of use and recommendation to others scored on a 5-point system'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Digital Decision Support System', 'App', 'Self-management'], 'conditions': ['Low Back Pain']}, 'referencesModule': {'references': [{'type': 'BACKGROUND', 'citation': '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'}, {'pmid': '32489674', 'type': 'DERIVED', 'citation': '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.'}], 'seeAlsoLinks': [{'url': 'http://www.selfback.eu', 'label': 'project webpage'}]}, 'descriptionModule': {'briefSummary': 'The pilot study precedes a larger randomized controlled trial, to be starting in February 2019.\n\nIn this pilot study all participants are allocated to the intervention group.\n\nThe 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.', 'detailedDescription': '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.\n\nThe 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.\n\nThe 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Seeking care from primary health-care practice or a specialised outpatient hospital facility (DK) for non-specific LBP within the past 8 weeks\n* LBP of any duration\n* Mild-to severe pain-related disability rated as 16 or below on the PROMIS-PF4 function scale.\n* Age: ≥18 years\n* 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)\n* Have a working email address and have access to a computer with internet access to complete questionnaires in a web browser.\n\nExclusion Criteria:\n\n* Not interested\n* Unable to speak, read or write in the national language (Danish/ Norwegian)\n* Cognitive impairment or learning disabilities\n* 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)\n* Serious mental illness, such as major depression, schizophrenia, and psychosis\n* Terminal illness\n* 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)\n* Fibromyalgia (diagnosed by a Health Care Professional)\n* Pregnancy\n* Previous back surgery\n* Ongoing participation in other research trials for LBP management'}, 'identificationModule': {'nctId': 'NCT03697759', 'acronym': 'selfBACK', 'briefTitle': 'A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY', 'organization': {'class': 'OTHER', 'fullName': 'University of Southern Denmark'}, 'officialTitle': 'A Decision Support System for Self-management of Low Back Pain - PILOTSTUDY', 'orgStudyIdInfo': {'id': 'S-20182000-24'}, 'secondaryIdInfos': [{'id': '2018/791', 'type': 'OTHER', 'domain': 'The Regional Committee for Medicine and Health Related Research Ethics'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Usual care + selfBACK', 'description': 'Participants will use the selfBACK system and app', 'interventionNames': ['Other: Usual care + selfBACK']}], 'interventions': [{'name': 'Usual care + selfBACK', 'type': 'OTHER', 'otherNames': ['selfBACK digital decision support system'], 'description': '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.\n\nThe 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.', 'armGroupLabels': ['Usual care + selfBACK']}]}, 'contactsLocationsModule': {'locations': [{'zip': '5230', 'city': 'Odense', 'country': 'Denmark', 'facility': 'Physical Activity and Health at Work, Department of Sports Science and Clinical Biomechanics, University of Southern Denmark', 'geoPoint': {'lat': 55.39594, 'lon': 10.38831}}, {'city': 'Trondheim', 'country': 'Norway', 'facility': 'Norwegian University of Science and Techonology', 'geoPoint': {'lat': 63.43049, 'lon': 10.39506}}], 'overallOfficials': [{'name': 'Karen Søgaard, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Southern Denmark'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Southern Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Norwegian University of Science and Technology', 'class': 'OTHER'}, {'name': 'National Research Centre for the Working Environment, Denmark', 'class': 'OTHER_GOV'}, {'name': 'University of Glasgow', 'class': 'OTHER'}, {'name': 'Robert Gordon University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}