Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2026-01-29 @ 3:57 PM
Study NCT ID:
NCT04552561
Status:
COMPLETED
Last Update Posted:
2021-09-27
First Post:
2020-09-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-24', 'studyFirstSubmitDate': '2020-09-01', 'studyFirstSubmitQcDate': '2020-09-11', 'lastUpdatePostDateStruct': {'date': '2021-09-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability/Feasibility of the the coached version of My MS Toolkit', 'timeFrame': 'Post-treatment, approximately week 8', 'description': 'Assessed by the Participant Satisfaction Evaluation Survey. This survey is a 17 item scale with one free text item and 16 items with scores ranging from 1-4 (lowest to highest) with total scores ranging from 16-64. Higher scores indicate greater levels of acceptability.'}], 'secondaryOutcomes': [{'measure': 'Impact of My MS Toolkit: Change in fatigue', 'timeFrame': 'Pre-treatment and Post-treatment, approximately week 8', 'description': "The Modified Fatigue Impact Scale will be used to assess fatigue. It is a self-report survey that contains 21 items. Each item is rated 0-4. Higher scores indicate a greater impact of fatigue on a person's activities."}, {'measure': 'Impact My MS Toolkit: Change in pain interference as measured by The Brief Pain Inventory Short Form', 'timeFrame': 'Pre-treatment and Post-treatment, approximately week 8', 'description': 'The Brief Pain Inventory Short Form (BPI-SF) is a 9-item questionnaire (15 prompts) with two domains: pain severity and pain interference. The 7 pain interference items have values which range from 0 ("does not interfere") to 10 ("completely interferes"); items are averaged for a scale score range of 0-10, with higher scores indicating more pain interference.'}, {'measure': 'Impact My MS Toolkit: Change in depressive symptoms as measured by the Patient Health Questionnaire depression scale', 'timeFrame': 'Pre-treatment and Post-treatment, approximately week 8', 'description': 'The eight-item Patient Health Questionnaire depression scale (PHQ-8) is established as a valid diagnostic and severity measure for depressive disorders in large clinical studies. Scores range from 0 - 24 and a score of 10 or greater is consistent with at least moderate depressive symptoms.'}, {'measure': 'Change in self-efficacy for managing symptoms as measured by the University of Washington Self-Efficacy Scale', 'timeFrame': 'Pre-treatment and Post-treatment, approximately week 8', 'description': 'Changes measured by the University of Washington Self-Efficacy Scale (UW-SES), higher score indicates higher levels of self-efficacy (total score range: 6-30)'}, {'measure': 'Participant perception of change', 'timeFrame': 'Post-treatment, approximately week 8', 'description': 'Perception of change is assessed by the patient global impression of change questionnaire, which is 1 question and responses range from 1-7. Higher numbers indicate greater improvement in condition.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Self-management', 'Web-based program'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': 'My MS Toolkit is a web-based symptom self-management program for persons with multiple sclerosis (MS).\n\nThis study is evaluating various aspects of My MS Toolkit plus coaching and how it impacts symptom self-management in multiple sclerosis. The research team believe that the toolkit will be feasible, acceptable, and beneficial to participants.', 'detailedDescription': "Study participants will be asked to use a newly developed web-based symptom self-management program, called the My MS Toolkit, for 8 weeks.\n\nThe My MS Toolkit includes 8 modules that describe symptom self-management strategies. Participants will explore the My MS Toolkit, following the prompts and guides built into the program, and meet with a study coach weekly for 15 to 30-minute telephone-delivered coaching sessions. Participants are encouraged to practice and apply the skills learned.\n\nThe study can be done from participants' homes using a reliable internet-connected device. No travel is required."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Multiple Sclerosis\n* Have access to a reliable, internet-connected device (e.g. computer, tablet). (Note: this study is conducted electronically and is not location dependent.)\n* One or more of the following:\n\n 1. Moderate/moderately severe depressive symptoms\n 2. Chronic pain\n 3. Presence of significant fatigue symptoms\n* Read, speak and understand English.\n\nExclusion Criteria:\n\n* Significant cognitive impairment\n* Current psychotherapy for symptoms'}, 'identificationModule': {'nctId': 'NCT04552561', 'briefTitle': 'My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'My MS Toolkit + Coaching: A Guided Web-based Symptom Self-Management Program for People With MS', 'orgStudyIdInfo': {'id': 'HUM00184319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'My MS Toolkit', 'description': '10 Participants asked to use My MS Toolkit and meet weekly with a study coach via telephone.', 'interventionNames': ['Behavioral: My MS Toolkit']}], 'interventions': [{'name': 'My MS Toolkit', 'type': 'BEHAVIORAL', 'description': 'My MS Toolkit, a web-based self-management intervention designed to help persons with Multiple Sclerosis self-manage fatigue, pain, and depressed mood.', 'armGroupLabels': ['My MS Toolkit']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'The University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}], 'overallOfficials': [{'name': 'Anna Kratz', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Michigan'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Physical Medicine and Rehabilitation', 'investigatorFullName': 'Anna Kratz', 'investigatorAffiliation': 'University of Michigan'}}}}