Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2025-12-26 @ 3:34 AM
Study NCT ID:
NCT06854718
Status:
RECRUITING
Last Update Posted:
2025-12-03
First Post:
2025-02-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pain With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D003704', 'term': 'Dementia'}, {'id': 'D008224', 'term': 'Lymphoma, Follicular'}], 'ancestors': [{'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-08-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-02', 'studyFirstSubmitDate': '2025-02-10', 'studyFirstSubmitQcDate': '2025-02-25', 'lastUpdatePostDateStruct': {'date': '2025-12-03', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Client Satisfaction Questionnaire', 'timeFrame': 'Post-intervention (approximately 8 weeks)', 'description': 'Caregiver completes. Score range: 1-4; higher score indicates better outcome'}], 'secondaryOutcomes': [{'measure': "Quality of life in Alzheimer's Disease Caregiver version and Patient version", 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Patient and Caregiver will complete Patient QOL. Score range: 13-52; higher score indicates better outcome'}, {'measure': 'Brief Pain Inventory-Interference Items', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Patient and Caregiver will complete Patient pain interference. Score range: 0-10; higher score indicates worse outcome'}, {'measure': 'Caregiver Self-Efficacy in Pain Management', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Caregiver will complete caregiver self-efficacy. Score range: 0-10; higher score indicates better outcome'}, {'measure': 'Numeric pain scale & verbal descriptor', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Patient will complete patient pain intensity. Score range: 0-19; higher score indicates worse outcome'}, {'measure': 'Checklist of nonverbal pain indicators', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Caregiver will complete patient pain intensity. Score range: 0-10; higher score indicates worse outcome'}, {'measure': 'Zarit burden interview', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Caregivers will complete caregiver burden. Score range: 0-88; higher score indicates worse outcome'}, {'measure': 'Caregiver appraisal-satisfaction scale', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Caregiver will complete caregiver satisfaction. Score range: 0-10; higher score indicates worse outcome'}, {'measure': 'Neuropsychiatric inventory', 'timeFrame': 'Baseline and post-intervention (approximately 8 weeks)', 'description': 'Caregiver will complete patient neuropsychiatry behaviors. Score range: 0-144; higher score indicates worse outcome'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pain', 'Dementia, Mild', 'Dementia, Moderate']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to develop a caregiver-assisted pain coping skills training program for older adults who have pain and mild to moderate dementia and are living at home with a family caregiver. The investigators are planning to recruit 30 patient-caregiver dyads (60 individuals).', 'detailedDescription': "Involving caregivers in a pain coping skills protocol is likely to optimize treatment outcomes in several ways.\n\nFirst, people with dementia (PWD) are likely to have difficulty learning and remembering pain coping skills; training the caregiver to coach the patient in the use of the skills is likely to improve the patients' acquisition and ongoing use of learned skills.\n\nSecond, caregiver involvement in pain coping skills training may increase their understanding of how to gauge how much pain the PWD is experiencing and the impact of pain management strategies. This understanding is increasingly important as the patient's disease progresses, and s/he is less able to report pain verbally.\n\nThird, caregiver-assisted pain management training may enhance caregivers' self-confidence for managing the patient's pain.\n\nFinally, by participating in the pain coping skills training protocol, caregivers may learn coping skills (such as relaxation) that can help them manage the stress associated with caring for a PWD and pain which can be significant."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients:\n\n* Mild or moderate dementia\n* Pain on most days for at least 3 months that interferes with function\n* Living at home (non-institutional)\n* Age ≥ 50\n* English Speaking\n\nCaregivers:\n\n* Provides on average at least 4 hours/day of care/assistance to the patient\n* Age ≥ 18\n* English Speaking\n\nExclusion Criteria:\n\nPatient and caregivers\n\n* Lacking capacity for interview or unable to provide informed consent/assent.\n* Visual or hearing impairments or severe behavioral problems that preclude participation.\n* Too sick to participate.'}, 'identificationModule': {'nctId': 'NCT06854718', 'acronym': 'PWD', 'briefTitle': 'Pain With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Duke University'}, 'officialTitle': 'Caregiver-assisted Pain Coping Skills Training for Dementia Pilot Study', 'orgStudyIdInfo': {'id': 'Pro00116129'}, 'secondaryIdInfos': [{'id': '1R61AG088938-01', 'link': 'https://reporter.nih.gov/quickSearch/1R61AG088938-01', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Patient-Caregiver Dyads', 'description': 'Patient and caregiver dyads will receive five 45-60 minute sessions over 6-8 week period. This will be over videoconference with a masters-level therapist. All sessions will be audio recorded.', 'interventionNames': ['Behavioral: Caregiver-Assisted Pain Coping Skills Training (CG-PCST)']}], 'interventions': [{'name': 'Caregiver-Assisted Pain Coping Skills Training (CG-PCST)', 'type': 'BEHAVIORAL', 'description': "Patient-caregiver dyads will receive five, forty-to-sixty-minute sessions over a six-to-eight-week period with a therapist to learn pain coping skills. These include training caregivers in strategies for assessing patient pain, including nonverbal pain behaviors (e.g., grimacing, bodily tension, labored breathing), which will become increasingly important as the patient's ability to express pain verbally decreases. The therapist will also train the caregiver to coach the patient in the use of the skills during activities that are challenging because of pain. We will focus on increasing positive patient-caregiver interactions and patient engagement in valued activities. Throughout the training, the therapist will help the patient and caregiver learn strategies for fostering regular home practice and application of the skills, identify challenges in using the skills, and find strategies for coping with challenges.", 'armGroupLabels': ['Patient-Caregiver Dyads']}]}, 'contactsLocationsModule': {'locations': [{'zip': '27705', 'city': 'Durham', 'state': 'North Carolina', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Laura Porter, Ph.D', 'role': 'CONTACT', 'email': 'porte008@mc.duke.edu', 'phone': '919-416-3436'}, {'name': 'Laura Porter, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Katherine Ramos, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Duke University Medical Center', 'geoPoint': {'lat': 35.99403, 'lon': -78.89862}}], 'centralContacts': [{'name': 'Laura Porter, Ph.D', 'role': 'CONTACT', 'email': 'Laura.Porter@duke.edu', 'phone': '919-416-3436'}, {'name': 'Katherine Ramos, Ph.D', 'role': 'CONTACT', 'email': 'Katherine.Ramos@duke.edu', 'phone': '919-416-3434'}], 'overallOfficials': [{'name': 'Laura Porter, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Duke University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Duke University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}, {'name': 'National Institutes of Health (NIH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}