Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2025-12-25 @ 7:48 PM
Study NCT ID:
NCT05934435
Status:
COMPLETED
Last Update Posted:
2025-04-10
First Post:
2023-06-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Empowered Relief Delivered by Nurses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}, {'id': 'D010146', 'term': 'Pain'}], 'ancestors': [{'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': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Biostatistician will be blinded to ER treatment group or Wait-list Control group.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'After randomized 1:1 to one of two unblinded study groups: ER and Wait-List Control, participants randomized to the ER group will complete the ER class. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 149}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2024-11-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-07', 'studyFirstSubmitDate': '2023-06-17', 'studyFirstSubmitQcDate': '2023-06-27', 'lastUpdatePostDateStruct': {'date': '2025-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Pain Catastrophizing', 'timeFrame': 'Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.', 'description': 'Measured by self-report'}], 'secondaryOutcomes': [{'measure': 'Change in Pain Intensity', 'timeFrame': 'Participants will be assessed at baseline, and then at 2, 4, and 8 week timepoints for change over time.', 'description': '0-10 Pain severity scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pain'], 'conditions': ['Pain, Chronic']}, 'descriptionModule': {'briefSummary': 'This study will investigate effects of a psychoeducation pain management skills intervention on adults with persistent pain by training a cohort of American Society for Pain Management Nursing (ASPMN) nurses to deliver and it \\[Empowered Relief (ER)\\], as a single-session video-conferenced program. The primary objective is to evaluate the effects of ASPMN nurse-provided ER versus waitlist control (WLC) on pain catastrophizing, pain bothersomeness, pain intensity, pain interference, sleep disturbance, physical function, depression, anxiety, and social isolation for patients with persistent pain. Secondarily, feasibility and acceptability of the ER program will be assessed through recruitment and retention data and qualitative satisfaction data.', 'detailedDescription': 'Design: This study will be conducted as a randomized controlled trial comparing effects of ER to a WLC of participants with persistent pain when ER is provided by ER-trained ASPMN nurses. The secondary aims of feasibility and acceptability will use qualitative descriptive methods.\n\nParticipants: Participants (N=170) will be adults aged 18 and above years with self- reported or clinically diagnosed persistent pain. Participants will be recruited at clinical sites identified by ER-trained nurses and can be self or clinician referred. Participants will complete an online eligibility form to screen for inclusion and exclusion criteria. Inclusion criteria: pain \\>3 months more than half the time, English fluency, ability to attend a one-time web-based class and complete web-based surveys, age \\> 18 years. Exclusion criteria: Previous participation in ER class, cognitive impairment, non-English speaking, or psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.\n\nProcedures: Twenty ASPMN nurses will receive ER training facilitated by Stanford Pain Relief Innovations Lab. ER- trained nurse providers will be ASPMN-member nurses of any clinical background. ASPMN nurses will be invited to apply to become a trainer with the following expectations: ability to fully participate in a live, online, 2-day ER instructor training, able to fluently complete instructor training and deliver the ER program in English, commitment to deliver 1-3 live, online, 2-hour ER programs for patient participants, and willingness to complete post-program surveys after each session they deliver reporting on number of participants and any barriers encountered. Recruitment will occur through ASPMN-related mechanisms of communication, including its website, national officers and directors, newsletter, research group, national committees, chapter leadership and listserv.\n\nAfter meeting eligibility criteria and completing informed consent, study participants will be asked to complete a baseline survey of demographics and health variables (as outlined in Table 1) and then randomized 1:1 to one of two unblinded study groups: ER and WLC. Participants randomized to the ER group will complete a HIPAA compliant, password protected Zoom ER class delivered by an ER-trained ASPMN nurse. A crossover intervention class will be offered to those patient participants randomized to WLC once the ER group has completed their class and follow up assessments, estimated at 2 months post intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age \\> 18 years\n* pain \\>3 months more than half the time\n* English fluency\n* ability to attend a one-time web-based class and complete web-based surveys.\n\nExclusion criteria:\n\n* Previous participation in ER class\n* cognitive impairment\n* non-English speaking\n* psychological factors that would preclude comprehension of material or full participation in the study as determined by the investigators.'}, 'identificationModule': {'nctId': 'NCT05934435', 'acronym': 'ERA', 'briefTitle': 'Empowered Relief Delivered by Nurses', 'organization': {'class': 'OTHER', 'fullName': 'Washington State University'}, 'officialTitle': 'Addressing Pain Care Inequities With Empowered Relief Delivered by ASPMN Nurses: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '20013-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Empowered Relief treatment', 'description': 'Participants randomized to the ER group will complete a HIPAA compliant, password protected 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse.', 'interventionNames': ['Other: Empowered Relief']}, {'type': 'OTHER', 'label': 'Wait-list Control', 'description': 'Participants randomized to the Wait-list Control group will continue their usual pain care for 2 months and complete surveys to compare with the experimental treatment group. After serving as controls, they will be invited to attend the 2-hour Zoom ER class delivered by an ER-trained ASPMN nurse.', 'interventionNames': ['Other: Empowered Relief']}], 'interventions': [{'name': 'Empowered Relief', 'type': 'OTHER', 'otherNames': ['ER'], 'description': 'psycho-educational pain skills training', 'armGroupLabels': ['Empowered Relief treatment', 'Wait-list Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99201', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Washington State University', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}], 'overallOfficials': [{'name': 'Marian Wilson, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Washington State University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP'], 'timeFrame': 'After publication', 'ipdSharing': 'YES', 'description': 'Can be requested from principal investigator', 'accessCriteria': 'Use for secondary analysis'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Washington State University', 'class': 'OTHER'}, 'collaborators': [{'name': 'American Society for Pain Management Nursing', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Marian Wilson', 'investigatorAffiliation': 'Washington State University'}}}}