Nctid:
NCT06236529
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000001416", "term"=>"Back Pain"}, {"id"=>"D000017116", "term"=>"Low Back Pain"}], "ancestors"=>[{"id"=>"D000010146", "term"=>"Pain"}, {"id"=>"D000009461", "term"=>"Neurologic Manifestations"}], "browseLeaves"=>[{"id"=>"M4714", "name"=>"Back Pain", "asFound"=>"Back Pain", "relevance"=>"HIGH"}, {"id"=>"M19433", "name"=>"Low Back Pain", "asFound"=>"Low Back Pain", "relevance"=>"HIGH"}, {"id"=>"M13066", "name"=>"Pain", "relevance"=>"LOW"}, {"id"=>"M12404", "name"=>"Neurologic Manifestations", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Nervous System Diseases", "abbrev"=>"BC10"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"SINGLE", "whoMasked"=>["OUTCOMES_ASSESSOR"], "maskingDescription"=>"The outcomes assessors were masked to treatment assignment"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>34}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2022-07-16", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2023-04-11", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-24", "studyFirstSubmitDate"=>"2024-01-24", "studyFirstSubmitQcDate"=>"2024-01-24", "lastUpdatePostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-02-01", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2023-04-11", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Acceptability of research", "timeFrame"=>"Baseline", "description"=>"Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate"}, {"measure"=>"Feasibility of study", "timeFrame"=>"Baseline", "description"=>"Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of \\< 20% of enrolled participants over the 26-week study"}], "secondaryOutcomes"=>[{"measure"=>"Patient Activation Measure (PAM) score", "timeFrame"=>"12 weeks", "description"=>"The Patient Activation Measure (PAM) is a 13-item instrument where patients are provided 5 response options, ranging from \"strongly agree\" to \"strongly disagree.\" Based on their answers, patients were assigned a numerical score ranging from 0 (no activation) to 100 (highest activation), and the score was used to stratify patients into 1 of 4 stages of activation: stage 1 (believes taking an active role is important), stage 2 (has the confidence and knowledge to take action), stage 3 (takes action), and stage 4 (stays the course under stress)"}, {"measure"=>"Oswestry Disability Index (ODI) score", "timeFrame"=>"12 weeks", "description"=>"Pain-related disability was assessed using the ODI, a 10-item measure of low back pain-related disability that evaluates the current effect of a patient's low back pain on various aspects of daily living. ODI scores range from 0 to 100, with higher scores indicating greater disability."}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["Self-management", "Nurse-led", "Web-based"], "conditions"=>["Chronic Low-back Pain", "Patient Activation"]}, "descriptionModule"=>{"briefSummary"=>"Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. \"Patient activation\" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.\n\nIn this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Adults (18+ years of age)\n* Seen in primary or specialty care practice for non-specific low back pain\n* Chronic low back pain per the NIH Task Force on Research Standards for cLBP\n* Worst back pain of at least 4/10 points\n* Oswestry disability index of at least 24%\n* English speaking\n\nExclusion Criteria:\n\n* History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months\n* Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline\n* \"Red flag\" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)\n* Neurological disorder resulting in moderate to severe movement dysfunction\n* Presence of any psychotic disorder"}, "identificationModule"=>{"nctId"=>"NCT06236529", "briefTitle"=>"Self-Management of Chronic Low Back Pain: Targeting Patient Activation", "organization"=>{"class"=>"OTHER", "fullName"=>"Johns Hopkins University"}, "officialTitle"=>"Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics", "orgStudyIdInfo"=>{"id"=>"IRB00313911"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"NO_INTERVENTION", "label"=>"Control", "description"=>"Participants receive no intervention."}, {"type"=>"ACTIVE_COMPARATOR", "label"=>"Self-management program (SMP)", "description"=>"Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks.", "interventionNames"=>["Behavioral: Self-management program"]}, {"type"=>"EXPERIMENTAL", "label"=>"Self-management program (SMP) with Health Behavior Change Counseling (HBCC)", "description"=>"Participants engage in a nurse-led evidence-based web-enabled group self-management class for 6 weeks and receive three telephone-based health behavioral change counseling sessions based on the principles and practices of motivational interviewing.", "interventionNames"=>["Behavioral: Health Behavior Change Counseling", "Behavioral: Self-management program"]}], "interventions"=>[{"name"=>"Health Behavior Change Counseling", "type"=>"BEHAVIORAL", "description"=>"A telephone-based intervention employing principles and practices of motivational interviewing.", "armGroupLabels"=>["Self-management program (SMP) with Health Behavior Change Counseling (HBCC)"]}, {"name"=>"Self-management program", "type"=>"BEHAVIORAL", "description"=>"An evidence-based 6-week SMP led by a registered nurse. The SMP was based on the Arthritis Self-Management Program and the Chronic Disease Self-Management Program.", "armGroupLabels"=>["Self-management program (SMP)", "Self-management program (SMP) with Health Behavior Change Counseling (HBCC)"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"21287", "city"=>"Baltimore", "state"=>"Maryland", "country"=>"United States", "facility"=>"Johns Hopkins University School of Medicine", "geoPoint"=>{"lat"=>39.29038, "lon"=>-76.61219}}], "overallOfficials"=>[{"name"=>"Richard L Skolasky", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Johns Hopkins School of Medicine"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Johns Hopkins University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
