Ignite Creation Date:
2025-12-24 @ 10:34 PM
Ignite Modification Date:
2026-04-23 @ 1:28 PM
Study NCT ID:
NCT02225535
Status:
COMPLETED
Last Update Posted:
2018-10-11
First Post:
2014-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017116', 'term': 'Low Back Pain'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-10', 'studyFirstSubmitDate': '2014-07-31', 'studyFirstSubmitQcDate': '2014-08-22', 'lastUpdatePostDateStruct': {'date': '2018-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2014-08-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Barriers and facilitators to use of Telehealth', 'timeFrame': '2 weeks', 'description': 'questionnaire'}], 'primaryOutcomes': [{'measure': 'Short term impact of patient/provider satisfaction', 'timeFrame': 'up to 2 weeks after assessment', 'description': 'questionnaire'}, {'measure': 'Short term outcome of patient experience with Telehealth', 'timeFrame': 'up to 2 weeks', 'description': 'qualitative questionnaire'}, {'measure': 'Medium term outcome of patient and provider satisfaction', 'timeFrame': '3 months', 'description': 'questionnaire'}, {'measure': 'Short term impact of patient function', 'timeFrame': 'up to 2 weeks after assessment', 'description': 'Modified Oswestry Disability questionnaire'}, {'measure': 'Short term impact on pain', 'timeFrame': 'up to 2 weeks after assessment', 'description': 'Numeric Pain Rating Scale - questionnaire'}, {'measure': 'Short term impact on quality of life', 'timeFrame': 'up to 2 weeks after assessment', 'description': 'Euro-Qol health survey instrument (EQ-5D)'}, {'measure': 'Medium term impact on pain', 'timeFrame': '3 months', 'description': 'Numeric Pain Rating Scale - questionnaire'}, {'measure': 'Medium term impact on quality of life', 'timeFrame': '3 months', 'description': 'Euro-Qol health survey instrument (EQ-5D)'}, {'measure': 'Medium impact on patient function', 'timeFrame': '3 months', 'description': 'Modified Oswestry Disability Index questionnaire'}], 'secondaryOutcomes': [{'measure': 'Cost effectiveness of each of 3 arms of study', 'timeFrame': '6 months', 'description': 'patient diaries'}, {'measure': 'Long term outcome on patient/provider satisfaction', 'timeFrame': '6 months', 'description': 'questionnaire'}, {'measure': 'Long term impact on quality of life', 'timeFrame': '6 months', 'description': 'Euro-Qol health survey instrument (EQ-5D)'}, {'measure': 'Long term impact on function', 'timeFrame': '6 months', 'description': 'Modified Oswestry Disability Index questionnaire'}, {'measure': 'Long term impact on pain', 'timeFrame': '6 months', 'description': 'Numeric Pain Rating Scale'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['low back pain', 'telehealth', 'videoconferencing', 'access to physical therapy', 'interprofessional care', 'rural health'], 'conditions': ['Chronic Low Back Pain']}, 'referencesModule': {'references': [{'pmid': '38846367', 'type': 'DERIVED', 'citation': "Lovo S, Imeah B, Sari N, O'Connell ME, Milosavljevic S, Angarita-Fonseca A, Bath B. Effectiveness of an interprofessional assessment and management approach for people with chronic low back disorders delivered via virtual care: A randomized controlled trial pilot intervention. Digit Health. 2024 Jun 5;10:20552076241260569. doi: 10.1177/20552076241260569. eCollection 2024 Jan-Dec."}, {'pmid': '27829573', 'type': 'DERIVED', 'citation': "Bath B, Lovo Grona S, Milosavljevic S, Sari N, Imeah B, O'Connell ME. Advancing Interprofessional Primary Health Care Services in Rural Settings for People with Chronic Low Back Disorders: Protocol of a Community-Based Randomized Controlled Trial. JMIR Res Protoc. 2016 Nov 9;5(4):e212. doi: 10.2196/resprot.5914."}]}, 'descriptionModule': {'briefSummary': 'The purpose of this project is to compare "usual care" for chronic low back disorders in a rural setting (nurse practitioner/NP) to two different means of integrating Physical Therapy (PT) into a rural health care team:\n\n1. in-person PT assessment, where the PT travels from an urban center\n2. interprofessional Telehealth assessment where the local NP is joined by a PT via Telehealth.\n\nThe project will evaluate health, systems and process outcomes, comparative effectiveness and costs of the three methods of assessment. The hypothesis is that an interprofessional Telehealth assessment with be as effective as an in-person PT assessment, but more effective than usual care.', 'detailedDescription': 'The study design will include two intervention groups and a control group with 20 participants in each group: 1. interprofessional videoconferencing intervention, 2. in-person PT and, 3. "usual-care" provided by a NP. Due to the interprofessional nature of the intervention, the NP involved in the telehealth-based intervention group may alter their "usual care" practice; therefore, the control group participants will be drawn from the practices of 2 NPs not involved in the Telehealth intervention providing services out of a different clinic. Each PT and the NP alone will complete a standardized online diagnostic classification tool.Participants will be randomly assigned to one of the three groups.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult 18-80\n* low back pain and/or related leg pain affecting function, \\>3 months duration\n\nExclusion Criteria:\n\n* clients within a third party payer insurance coverage system\n* clients with primarily neck or thoracic pain\n* clients with language or comprehension difficulties that would limit completion of paperwork'}, 'identificationModule': {'nctId': 'NCT02225535', 'briefTitle': 'Investigation of a Physiotherapist and Nurse Practitioner Intervention for Chronic Low Back Disorders Delivered Through Telehealth', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Advancing Interprofessional Primary Health Care Services in Rural Settings for People With Chronic Low Back Disorders: Investigation of a Physiotherapist and Nurse Practitioner Intervention Delivered Through Telehealth', 'orgStudyIdInfo': {'id': 'Bio13-241'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Usual Care (NP)', 'description': 'Rural NP with client in-person, usual care', 'interventionNames': ['Other: NP face to face management of Chronic Low Back Pain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PT in-person', 'description': "Urban PT travels to rural area to manage patient's back pain in-person.", 'interventionNames': ['Other: PT face to face management of Chronic Low Back Pain']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PT/NP Telehealth', 'description': 'Intervention: Rural NP is joined by PT via Telehealth for interprofessional videoconference with patient', 'interventionNames': ['Other: Interprofessional Videoconferencing for Chronic Low Back Pain']}], 'interventions': [{'name': 'NP face to face management of Chronic Low Back Pain', 'type': 'OTHER', 'description': 'usual NP management of chronic low back disorder', 'armGroupLabels': ['Usual Care (NP)']}, {'name': 'PT face to face management of Chronic Low Back Pain', 'type': 'OTHER', 'description': 'Includes manual therapy, education, exercise', 'armGroupLabels': ['PT in-person']}, {'name': 'Interprofessional Videoconferencing for Chronic Low Back Pain', 'type': 'OTHER', 'description': 'Includes manual therapy, education, exercise.', 'armGroupLabels': ['PT/NP Telehealth']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7J4W3', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Brenna Bath, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Physical Therapy, University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Saskatchewan Health Research Foundation', 'class': 'OTHER'}, {'name': 'Ralston Brothers Grant (Kelsey Trail Health Region)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor, School of Physical Therapy', 'investigatorFullName': 'Brenna Bath', 'investigatorAffiliation': 'University of Saskatchewan'}}}}