Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2025-12-26 @ 2:02 AM
Study NCT ID:
NCT06446505
Status:
RECRUITING
Last Update Posted:
2024-06-06
First Post:
2024-05-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-06-04', 'studyFirstSubmitDate': '2024-05-22', 'studyFirstSubmitQcDate': '2024-06-04', 'lastUpdatePostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Acceptability tool from the Ottawa Hospital Research Institute', 'timeFrame': 'Baseline', 'description': 'This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.'}, {'measure': 'Acceptability tool from the Ottawa Hospital Research Institute', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This tool measures the comprehensibility of components of the decision aid including its length, amount of information, balance and suitability for decision-making. Higher scores indicate that the tool is more acceptable.'}, {'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': 'Baseline', 'description': 'The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.'}, {'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': '1 Month', 'description': 'The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.'}, {'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': '3 Months', 'description': 'The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.'}, {'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.'}, {'measure': 'Decisional Conflict Scale (DCS)', 'timeFrame': '2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery', 'description': 'The Decisional Conflict Scale measures the perceptions of uncertainty in choosing options, including uncertainty related to feeling uninformed, unclear about personal values and unsupported in decision-making. The minimum score is a 0 and the maximum score is 100. Higher scores indicate more decisional conflict.'}], 'secondaryOutcomes': [{'measure': 'Decision Quality Worksheet', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.'}, {'measure': 'Decision Quality Worksheet', 'timeFrame': '2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery', 'description': 'The worksheet measures how well participants understood the options and outcomes presented in the decision aid, as well as if their decision was consistent with their goals and values. For the knowledge portion of the worksheet, the scores range from 0 to 10, with higher scores indicating increased knowledge about DBS.'}, {'measure': 'Decision Self-Efficacy scale', 'timeFrame': 'Baseline', 'description': 'This scale measures the participant\'s self-confidence in or belief in one\'s ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".'}, {'measure': 'Decision Self-Efficacy scale', 'timeFrame': '3 Months', 'description': 'This scale measures the participant\'s self-confidence in or belief in one\'s ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".'}, {'measure': 'Decision Self-Efficacy scale', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This scale measures the participant\'s self-confidence in or belief in one\'s ability to make decisions and participate in shared decision-making. The scores range from 0 to 100. A score of 0 means "extremely low self efficacy" and a score of 100 means "extremely high self efficacy".'}, {'measure': 'Decision Readiness Instrument', 'timeFrame': 'Baseline', 'description': 'This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".'}, {'measure': 'Decision Readiness Instrument', 'timeFrame': '1 Month', 'description': 'This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".'}, {'measure': 'Decision Readiness Instrument', 'timeFrame': '3 Months', 'description': 'This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".'}, {'measure': 'Decision Readiness Instrument', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This validated, single-item instrument assesses how ready the participant is to make a decision about deep brain stimulation surgery. The scores vary from 0 "not at all ready" to 5 "completely ready".'}, {'measure': 'Satisfaction with Decision Scale', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.'}, {'measure': 'Satisfaction with Decision Scale', 'timeFrame': '2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery', 'description': 'This scale measures how satisfied the participant is with their decision about whether or not to undergo deep brain stimulation surgery. The areas of satisfaction include how informed they were, if the decision was the best for them, if the decision was consistent with their values and if they had as much input as they wanted. Scores range from 6 to 30. Higher scores indicate higher satisfaction with the decision.'}, {'measure': "Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)", 'timeFrame': 'Baseline', 'description': "This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life."}, {'measure': "Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)", 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': "This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life."}, {'measure': "Parkinson's Disease Quality of Life Questionnaire - 8 (PDQ-8)", 'timeFrame': '2 months post-Deep brain stimulation surgery or 2 months post decision not to undergo surgery', 'description': "This questionnaire measures quality of life in Parkinson's disease related to the 8 dimensions of mobility, activities of daily living, emotional well-being, stigma, social support, cognition, communication and bodily discomfort. Scores range from 0 to 100 with higher scores indicating lower quality of life."}, {'measure': 'Expectations', 'timeFrame': 'Baseline', 'description': "Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery."}, {'measure': 'Expectations', 'timeFrame': '1 Month', 'description': "Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery."}, {'measure': 'Expectations', 'timeFrame': '3 Months', 'description': "Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery."}, {'measure': 'Expectations', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': "Asks participants which Parkinson's symptoms they expect to see improvement in with deep brain stimulation surgery."}, {'measure': 'Shared Decision-Making Questionnaire - 9', 'timeFrame': '1 Month', 'description': 'This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).'}, {'measure': 'Shared Decision-Making Questionnaire - 9', 'timeFrame': '3 Months', 'description': 'This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).'}, {'measure': 'Shared Decision-Making Questionnaire - 9', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This questionnaire measures the degree of shared decision-making that took place in physician visits discussing deep brain stimulation surgery. The scores range from 0 (no perceived shared decision-making) to 100 (highest level of perceived shared decision-making).'}, {'measure': 'Trust in the Surgeon Scale', 'timeFrame': '2 weeks after decision for deep brain stimulation surgery', 'description': 'This scale measures how much the participant trusts their surgeon. The scale ranges from 11 to 55, with higher scores indicating a higher level of trust.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Deep Brain Stimulation', 'Decision Aid'], 'conditions': ['Parkinson Disease']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if a Decision Aid can help patients with Parkinson's disease make a decision about undergoing Deep Brain Stimulation surgery. The main questions it aims to answer are:\n\n* Is the Decision Aid acceptable to patients with Parkinson's disease considering Deep Brain Stimulation surgery?\n* Does the decision aid improve decision quality (informed, value-based decision) and uncertainty about the decision?\n\nResearchers will compare immediate use of the decision aid during the evaluation process for deep brain stimulation surgery to delayed introduction of the decision aid.\n\nParticipants will:\n\n* Receive the decision aid at the beginning of the evaluation process or towards the end\n* Complete surveys at 5 visits (remote or in-person) over approximately 6 months"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults with a diagnosis of Parkinson's disease referred for deep brain stimulation surgery evaluation at the University of Colorado\n\nExclusion Criteria:\n\n* Atypical Parkinsonism\n* Diagnosis of Dementia"}, 'identificationModule': {'nctId': 'NCT06446505', 'briefTitle': "Evaluation of a Decision Aid for Deep Brain Stimulation Surgery for Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': "Feasibility, Acceptability, and Effectiveness of an Online Decision Aid for Patients With Parkinson's Disease Considering Deep Brain Stimulation Surgery Using a Pragmatic, Randomized Pilot Trial", 'orgStudyIdInfo': {'id': '23-2390'}, 'secondaryIdInfos': [{'id': 'K12AR084226', 'link': 'https://reporter.nih.gov/quickSearch/K12AR084226', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early Decision Aid', 'description': 'Participants will receive the Decision Aid at baseline.', 'interventionNames': ['Other: Deep Brain Stimulation Decision Aid']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed Decision Aid', 'description': 'Participants will receive the Decision Aid at the end of the deep brain stimulation surgery evaluation process.', 'interventionNames': ['Other: Deep Brain Stimulation Decision Aid']}], 'interventions': [{'name': 'Deep Brain Stimulation Decision Aid', 'type': 'OTHER', 'description': 'An online decision support tool that provides education about deep brain stimulation and the alternatives, and includes value clarification exercise.', 'armGroupLabels': ['Delayed Decision Aid', 'Early Decision Aid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Michelle E Fullard', 'role': 'CONTACT', 'email': 'michelle.fullard@cuanschutz.edu', 'phone': '303-724-2194'}, {'name': 'Erika Shelton', 'role': 'CONTACT', 'email': 'erika.shelton@cuanschutz.edu', 'phone': '3037244644', 'phoneExt': 'Fullard'}, {'name': 'Michelle E Fullard, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Colorado Anschutz', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'centralContacts': [{'name': 'Michelle E Fullard, MD', 'role': 'CONTACT', 'email': 'michelle.fullard@cuanschutz.edu', 'phone': '3037242194'}, {'name': 'Erika Shelton', 'role': 'CONTACT', 'email': 'erika.shelton@cuanschutz.edu', 'phone': '3037244644'}], 'overallOfficials': [{'name': 'Michelle E Fullard, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado, Denver'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'We plan to share the de-identified dataset after the primary results have been accepted for publication. No patient identifiers will be included in the shared data.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}