Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2026-01-04 @ 7:44 AM
Study NCT ID:
NCT06568250
Status:
RECRUITING
Last Update Posted:
2024-08-23
First Post:
2024-08-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2025-12-17'}], 'estimatedResultsFirstSubmitDate': '2025-12-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D059350', 'term': 'Chronic Pain'}], 'ancestors': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-20', 'studyFirstSubmitDate': '2024-08-19', 'studyFirstSubmitQcDate': '2024-08-20', 'lastUpdatePostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants Recruited', 'timeFrame': '3 months', 'description': '40 rural-dwelling VA patients recruited'}, {'measure': 'Percentage of Female and Racial/Ethnic Minoritized Participants Recruited', 'timeFrame': '3 months', 'description': 'At least 35% female and 35% racial/ethnic minority patients recruited'}, {'measure': 'Percentage of Participants Who Report Being "Somewhat Satisfied" or "Very Satisfied" with the Program on a 7-point Scale', 'timeFrame': '3 months', 'description': '75% satisfied with RAMP program'}, {'measure': 'Percentage of Participants Who Attend/Engage with Recommended Number of Sessions', 'timeFrame': '3 months', 'description': '75% attend/engage with recommended # of sessions (≥ 7/12)'}, {'measure': 'Intervention Fidelity Based on Observation By Trained Raters', 'timeFrame': '3 months', 'description': 'Facilitators deliver 90% of session activities 90% of the time'}, {'measure': 'Percentage of Participants Who Complete Post-Treatment Data Collection', 'timeFrame': '3 month', 'description': '\\>80% complete post-treatment data collection (at 3 months)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['chronic pain', 'mindfulness', 'complementary therapies', 'models, biopsychosocial', 'rural Veterans health'], 'conditions': ['Chronic Pain']}, 'descriptionModule': {'briefSummary': 'This project addresses the significant challenge of providing evidence-based non-pharmacologic pain management to rural-dwelling Veterans in the VA healthcare system who have chronic pain. For this preparatory phase (UG3) the investigators will conduct a pilot study of 40 rural VA patients with chronic pain to assess the feasibility of delivering RAMP (experimental intervention for the UH3 trial) in terms of recruitment and engagement, intervention fidelity and adherence, data collection, and other key metrics.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Veteran participants must be rural dwelling\n* Patient's Veterans Affairs (VA) primary care provider is in the Southeast region of the US\n* Email address in the VA electronic health record (EHR)\n* Report pain at least most days in the past 3 months\n* Brief Pain Inventory (BPI) Pain Interference subscale score of 4 or greater\n* Willingness and ability to complete study activities including meeting remotely via videoconferencing when program sessions are held\n\nExclusion Criteria:\n\n* Participation in a prior project conducted by the study team on mindfulness for pain (NCT0456158) or an engagement activities advisor for the current project\n* Current enrollment in a research study for pain\n* Current enrollment in a similar facilitated, multi-week, multi-modal CIH program\n* Severe, poorly controlled psychiatric or substance use disorder (based on chart review using structured checklists, conducted by trained staff who are trained and supervised by a clinical psychologist)"}, 'identificationModule': {'nctId': 'NCT06568250', 'acronym': 'RAMP UG3', 'briefTitle': 'Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention - UG3 Pilot', 'organization': {'class': 'FED', 'fullName': 'Minneapolis Veterans Affairs Medical Center'}, 'officialTitle': 'Reaching Rural Veterans: Applying Mind-Body Skills for Pain Using a Whole Health Telehealth Intervention', 'orgStudyIdInfo': {'id': '1UG3NR020929-01', 'link': 'https://reporter.nih.gov/quickSearch/1UG3NR020929-01', 'type': 'NIH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'interventionNames': ['Behavioral: RAMP program']}], 'interventions': [{'name': 'RAMP program', 'type': 'BEHAVIORAL', 'description': 'The RAMP program is a 12-week virtual program consisting of an individual session (50 minutes) with a Whole Health Coach followed by 11 weekly interactive group sessions (90 minutes each) with pre-recorded expert led education videos, mind-body skill training and practice, and facilitated discussions.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '55417', 'city': 'Minneapolis', 'state': 'Minnesota', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Diana Burgess, PhD', 'role': 'CONTACT', 'email': 'diana.burgess@va.gov'}, {'name': 'Lee Cross, MPH', 'role': 'CONTACT', 'email': 'lee.cross@va.gov'}], 'facility': 'Minneapolis VAMC', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}], 'centralContacts': [{'name': 'Diana Burgess, PhD', 'role': 'CONTACT', 'email': 'diana.burgess@va.gov', 'phone': '612-467-1591'}, {'name': 'Lee Cross, MPH', 'role': 'CONTACT', 'email': 'lee.cross@va.gov', 'phone': '612-629-7568'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minneapolis Veterans Affairs Medical Center', 'class': 'FED'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Core Investigator', 'investigatorFullName': 'Diana J. Burgess', 'investigatorAffiliation': 'Minneapolis Veterans Affairs Medical Center'}}}}