Ignite Creation Date:
2025-12-25 @ 1:22 AM
Ignite Modification Date:
2025-12-25 @ 11:31 PM
Study NCT ID:
NCT05129293
Status:
COMPLETED
Last Update Posted:
2024-10-18
First Post:
2021-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Improving Prospective Memory Via Telehealth
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009103', 'term': 'Multiple Sclerosis'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], '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'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'MSResearch@TrinityHealthOfNE.org', 'phone': '860-714-3005', 'title': 'Mandell Center Research Team', 'organization': 'Trinity Health Of New England'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Six weeks', 'eventGroups': [{'id': 'EG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation', 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Memory for Intentions Test Total Score Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory'}, {'id': 'OG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '32.24', 'spread': '21.78', 'groupId': 'OG000'}, {'value': '38.94', 'spread': '24.29', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '35.02', 'spread': '22.77', 'groupId': 'OG000'}, {'value': '45.40', 'spread': '36.62', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.229', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance'}], 'paramType': 'MEAN', 'timeFrame': 'Six weeks', 'description': 'Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \\<1 9 (coded as 0 for analyses) to \\>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Memory for Intentions Test Time Cue Subscale Percentile', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory'}, {'id': 'OG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.00', 'spread': '19.75', 'groupId': 'OG000'}, {'value': '51.78', 'spread': '24.09', 'groupId': 'OG001'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '57.89', 'spread': '30.53', 'groupId': 'OG000'}, {'value': '59.52', 'spread': '29.89', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.040', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance'}], 'paramType': 'MEAN', 'timeFrame': 'Six weeks', 'description': 'Performance on objective prospective memory (time-based)', 'unitOfMeasure': 'Percentile', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Perceived Deficits Questionnaire-Prospective Memory Subscale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '18', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory'}, {'id': 'OG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '10.18', 'spread': '2.70', 'groupId': 'OG000'}, {'value': '8.44', 'spread': '2.55', 'groupId': 'OG001'}]}]}, {'title': 'Post-Treatment', 'categories': [{'measurements': [{'value': '8.79', 'spread': '2.60', 'groupId': 'OG000'}, {'value': '8.30', 'spread': '2.74', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.266', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Adjusted for disease duration, SymptoMScreen depression and anxiety scores, and Test of Everyday Cognition baseline performance'}], 'paramType': 'MEAN', 'timeFrame': 'Six weeks', 'description': 'Subjective prospective memory. The five items in the subscale are summed, with scores ranging between 0 and 20. Higher scores indicate more subjective prospective memory issues.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory'}, {'id': 'FG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '18'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '16'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.\n\nProspective Memory Intervention: Cognitive remediation focusing on prospective memory'}, {'id': 'BG001', 'title': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.\n\nEducational: Psychoeducation'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '47.29', 'spread': '9.15', 'groupId': 'BG000'}, {'value': '48.17', 'spread': '9.8', 'groupId': 'BG001'}, {'value': '47.74', 'spread': '9.37', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '29', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Race', 'categories': [{'title': 'White', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '28', 'groupId': 'BG002'}]}, {'title': 'Black', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}, {'title': 'Multi-racial/Other', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-01-03', 'size': 504306, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-06-17T08:52', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-10-17', 'studyFirstSubmitDate': '2021-11-10', 'resultsFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2021-11-10', 'lastUpdatePostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-10-17', 'studyFirstPostDateStruct': {'date': '2021-11-22', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-10-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Memory for Intentions Test Total Score Percentile', 'timeFrame': 'Six weeks', 'description': 'Performance on objective prospective memory (overall performance). The MIST Total Score is calculated by summing the raw scores from the six subscales, which is transformed into percentiles using age- and education-stratified normative data. Scores ranged from \\<1 9 (coded as 0 for analyses) to \\>99 (coded as 100 for analyses), with higher scores indicating better prospective memory performance.'}, {'measure': 'Memory for Intentions Test Time Cue Subscale Percentile', 'timeFrame': 'Six weeks', 'description': 'Performance on objective prospective memory (time-based)'}], 'secondaryOutcomes': [{'measure': 'Perceived Deficits Questionnaire-Prospective Memory Subscale', 'timeFrame': 'Six weeks', 'description': 'Subjective prospective memory. The five items in the subscale are summed, with scores ranging between 0 and 20. Higher scores indicate more subjective prospective memory issues.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prospective memory', 'cognitive dysfunction', 'multiple sclerosis'], 'conditions': ['Multiple Sclerosis']}, 'descriptionModule': {'briefSummary': "Up to 70% of persons with multiple sclerosis (PwMS) experience cognitive impairment, which can have a significant impact on several aspects of their daily lives. One cognitive domain that has been shown to impact daily functioning, but is understudied in MS, is prospective memory (PM). While there have been successful PM interventions in other clinical populations, to date there has not been a specific PM intervention for PwMS that has been tested in a clinical trial.\n\nThe study will be a double-masked randomized feasibility trial, with 18 participants randomized to a PM intervention and 18 participants randomized to an active control (psychoeducation). Participants will meet with an interventionist twice a week for four weeks. Feasibility will be assessed via 1) recruitment, enrollment, and retention; 2) adherence to the treatment; 3) treatment credibility and expectancy; and 4) treatment satisfaction. A preliminary effect size (Cohen's d) will be computed for the group difference using participants' performance on the Memory for Intentions Test, which will be given at baseline (week 1) and post-treatment (week 6). Participants will also complete a battery of neuropsychological measures as part of their baseline and post-treatment assessments."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinical diagnosis of MS\n* Able to read, write, and speak in English\n* Between the ages of 18 and 60\n* All genders\n* No history of other serious neurologic or psychiatric illness, including drug or alcohol misuse\n* No relapses within the past two months\n* Access to the Internet and a web camera\n* Not enrolled in a cognitive rehabilitation program within the past six months\n* Self-reported issues "remembering places they have to be" and "things they have to do"\n\nExclusion Criteria:\n\n* No diagnosis of MS\n* Unable to complete the study protocol due to language barriers\n* Younger than 18 or older than 61\n* No gender exclusions\n* History of other serious neurologic or psychiatric illness, including drug or alcohol misuse\n* Had a relapse within the past two months\n* No access to the Internet and/or a web camera\n* Currently enrolled or enrolled in a cognitive rehabilitation program within the past six months\n* No self-reported issues with "remembering places they have to be" or "things they have to do"'}, 'identificationModule': {'nctId': 'NCT05129293', 'acronym': 'TPMI', 'briefTitle': 'Improving Prospective Memory Via Telehealth', 'organization': {'class': 'OTHER', 'fullName': 'Trinity Health Of New England'}, 'officialTitle': 'Improving Prospective Memory Via Telehealth: A Randomized Feasibility Trial', 'orgStudyIdInfo': {'id': 'MSH 21-63'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Prospective Memory Intervention', 'description': 'Participants randomized to the PM intervention (active group) will meet with an interventionist twice a week for four weeks. The first four sessions will focus on visual imagery, while the last four sessions will focus on implementation intentions. Participants will be led through a manualized treatment.', 'interventionNames': ['Behavioral: Prospective Memory Intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Educational', 'description': 'The control group (Education) will meet with a research assistant for the same frequency of sessions and will receive psychoeducation on MS and cognitive functioning. The interventionists will be following a manual and accompanying PowerPoint slides.', 'interventionNames': ['Behavioral: Educational']}], 'interventions': [{'name': 'Prospective Memory Intervention', 'type': 'BEHAVIORAL', 'description': 'Cognitive remediation focusing on prospective memory', 'armGroupLabels': ['Prospective Memory Intervention']}, {'name': 'Educational', 'type': 'BEHAVIORAL', 'description': 'Psychoeducation', 'armGroupLabels': ['Educational']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06112', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Mount Sinai Rehabilitation Hospital', 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Trinity Health Of New England', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}