Ignite Creation Date:
2025-12-26 @ 10:56 AM
Ignite Modification Date:
2025-12-31 @ 12:38 PM
Study NCT ID:
NCT04662008
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}], 'ancestors': [{'id': 'D020278', 'term': 'Demyelinating Autoimmune Diseases, CNS'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D003711', 'term': 'Demyelinating Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-04', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-03-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'anxiety, depression, and stress (DASS-42)', 'timeFrame': 'Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks', 'description': 'Change from baseline in anxiety, depression, and stress levels. Each of the three DASS scales contains 14 items. Using a 4-point Likert scale, scores range from 0- 42 for each scale. Higher scores indicate more depression, anxiety, and stress.'}], 'secondaryOutcomes': [{'measure': 'COVID specific anxiety (CAS scale)', 'timeFrame': 'Each subject will be given the assessments at 3 points during the study: baseline, 6 weeks, and 12 weeks', 'description': 'Change from baseline in COVID specific anxiety. Using a 5-point scale, from 0 (not at all) to 4 (nearly every day), total score ranges from 0-20 while individual items range from 0-4. Higher scores indicate higher anxiety.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Multiple Sclerosis', 'Caregivers']}, 'referencesModule': {'references': [{'pmid': '34435971', 'type': 'DERIVED', 'citation': 'Douglas SL, Plow M, Packer T, Lipson AR, Lehman MJ. Psychoeducational Interventions for Caregivers of Persons With Multiple Sclerosis: Protocol for a Randomized Trial. JMIR Res Protoc. 2021 Aug 26;10(8):e30617. doi: 10.2196/30617.'}]}, 'descriptionModule': {'briefSummary': 'This study is an enhancement of the Fatigue Management Programs for People with MS study (NCT03550170). The purpose of this randomized clinical trial is to test the effectiveness of two interventions delivered remotely to support unpaid caregivers (UC) of people with multiple sclerosis (MS). We hypothesize that a high resource intervention will be significantly better than a lower resource intervention in terms of the primary outcome (UC anxiety, depression, and stress) and secondary outcome (COVID specific anxiety).', 'detailedDescription': 'UCs are often caring for persons with chronic disabling conditions, who are at higher risk for severe COVID-19 illness. This presents incredibly stressful situations for UCs, which can result in depression, anxiety, and worse health outcomes both for them and their care recipients. Until a vaccine becomes available, these demands will force UCs to provide more support, whether in-person or remotely, for persons with MS. The aim of this study is to compare 2 modes of supporting UCs of people with MS. We will compare the effectiveness of a high resource highly tailored intervention that includes tele-coaching intervention (delivered via videoconference or phone) + web site information to a low-resource web-site only intervention. Our primary outcomes are UC anxiety, depression, and stress (DASS-42 scale) and a secondary outcome is COVID specific anxiety (CAS scale). These 2 interventions were selected because they will inform administrators and clinicians on whether a resource-intensive or a low-resource intervention is needed to yield meaningful outcomes. The comparison will also help UC decide how they should spend their limited time. These interventions are relevant to UCs of people with MS because of their need for tailored information provided in flexible ways to promote learning and support.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. An adult family member or friend (18 years of age or older) of a person with MS\n2. Self-identified as an unpaid caregiver for person with MS\n3. Access to internet\n4. Capable of providing informed consent in English\n\nExclusion Criteria:\n\n1. Under age 18\n2. Cannot speak English\n3. Unable to provide consent\n4. No access to the internet'}, 'identificationModule': {'nctId': 'NCT04662008', 'briefTitle': 'Offering Support and Electronic Resources for Care Partners of Those With Multiple Sclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Case Western Reserve University'}, 'officialTitle': 'CLOSER_MS: Communicating With Local or Distance Caregivers Offering Support and Electronic Resources', 'orgStudyIdInfo': {'id': 'MS-1610-37015 enhancement'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'High resource tailored intervention', 'description': 'Tele-coaching arm', 'interventionNames': ['Behavioral: Tele-coaching', 'Behavioral: Website']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Low-resource web-only intervention', 'description': 'Website arm', 'interventionNames': ['Behavioral: Website']}], 'interventions': [{'name': 'Tele-coaching', 'type': 'BEHAVIORAL', 'description': 'This intervention arm will receive 4 one-to-one tele-coaching sessions facilitated by an advanced practice social worker. The sessions will take place over a 6-week period and will begin with a needs assessments to allow for tailoring of the intervention sessions. The sessions will include information and support in the areas of: general MS information, strategies for caring for a loved one with MS, MS and Covid (care strategies), caring for yourself, and planning for the future. The intervention will take place using Zoom videoconferencing technology or via telephone- per subject preference. In addition, all subjects will receive access to a study-specific website. The website will have links to publicly available information including general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.', 'armGroupLabels': ['High resource tailored intervention']}, {'name': 'Website', 'type': 'BEHAVIORAL', 'description': 'This intervention arm will receive access to a study-specific website. The website will have links to publicly available information including: general information about MS, online information, self-care, communication, caregiving, COVID-19, future planning.', 'armGroupLabels': ['High resource tailored intervention', 'Low-resource web-only intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '44124', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Case Western Reserve University', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Case Western Reserve University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}