Ignite Creation Date:
2025-12-25 @ 2:34 AM
Ignite Modification Date:
2025-12-29 @ 7:20 AM
Study NCT ID:
NCT04343534
Status:
COMPLETED
Last Update Posted:
2024-01-05
First Post:
2020-04-09
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'KSEPUCHA@mgh.havard.edu', 'phone': '617-724-3350', 'title': 'Dr. Karen R. Sepucha', 'organization': 'Massachusetts General Hospital'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Survey responses were assessed within 2 weeks of survey completion for evidence of adverse events.', 'description': 'In addition to reviewing survey responses, participants were given the contact information for 3 members of the study team prior to the start of the survey should they experience a problem or need to report an adverse event.', 'eventGroups': [{'id': 'EG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.', 'otherNumAtRisk': 230, 'deathsNumAtRisk': 230, 'otherNumAffected': 0, 'seriousNumAtRisk': 230, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.', 'otherNumAtRisk': 264, 'deathsNumAtRisk': 264, 'otherNumAffected': 0, 'seriousNumAtRisk': 264, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Shared Decision Making Process Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.35', 'spread': '1.11', 'groupId': 'OG000'}, {'value': '2.51', 'spread': '1.05', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.092', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.15', 'ciLowerLimit': '-0.02', 'ciUpperLimit': '0.33', 'groupDescription': 'SDM Process score distributions were compared to determine of the scores spanned the range of possible values, were normally distributed, had low rates of missing data, and whether there was indications of floor or ceiling effects.\n\nwe conducted independent t-tests to determine if there were differences in SDM Process scores between the two versions.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline survey', 'description': 'The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who answered the shared decision making process items and provided sufficient information to calculate a SDM Process score.'}, {'type': 'SECONDARY', 'title': 'Decisional Conflict Tool (SURE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '227', 'groupId': 'OG000'}, {'value': '258', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '63', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline survey', 'description': 'Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates high decisional conflict, 4 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict. The measure is top-scored and we report the percentage of participants who scored a 4 ("no decisional conflict).', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed all 4 items of the short decisional conflict scale. Only 485/494 participants provided enough information to calculate a SURE score.'}, {'type': 'SECONDARY', 'title': 'Decision Regret Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '18', 'groupId': 'OG000'}, {'value': '21', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline survey', 'description': '5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Participants who answered all 5 decision regret questions. All 494 participants provided enough information to calculate decision regret score.'}, {'type': 'SECONDARY', 'title': 'Single-Item Measure of Decision Regret', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'title': 'Definitely yes', 'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '134', 'groupId': 'OG001'}]}, {'title': 'Probably yes', 'measurements': [{'value': '95', 'groupId': 'OG000'}, {'value': '102', 'groupId': 'OG001'}]}, {'title': 'Probably no', 'measurements': [{'value': '15', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}, {'title': 'Definitely no', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline survey', 'description': 'Single item asking "If you knew then what you know now, do you think you would make the same decision about depression?" Responses are definitely yes, probably yes, probably no and definitely no.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who answered the single-item regret question.'}, {'type': 'SECONDARY', 'title': 'Treatment Preference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '263', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'title': 'Anti-depressant medicine alone', 'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '91', 'groupId': 'OG001'}]}, {'title': 'Counseling or therapy alone', 'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}]}, {'title': 'Both medicine and counseling', 'measurements': [{'value': '125', 'groupId': 'OG000'}, {'value': '138', 'groupId': 'OG001'}]}, {'title': 'Do something else', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline survey', 'description': 'Single item asking "What did you want to do to manage your depression" with response options (1) Anti-depressant medicine alone, (2) Counseling or therapy alone, (3) Both medicine and counseling, and (4) Do something else.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who answered the treatment preference question. 493/494 provided information for this question'}, {'type': 'SECONDARY', 'title': 'Adapted Controlled Preference Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'title': 'Mainly my decision', 'measurements': [{'value': '107', 'groupId': 'OG000'}, {'value': '125', 'groupId': 'OG001'}]}, {'title': "Mainly the healthcare provider's decision", 'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}, {'title': 'We made the decision together', 'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '112', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Baseline survey', 'description': 'Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who answered the controlled preference scale question.'}, {'type': 'SECONDARY', 'title': 'Shared Decision Making Process Measure Retest', 'denoms': [{'units': 'Participants', 'counts': [{'value': '79', 'groupId': 'OG000'}, {'value': '84', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.27', 'spread': '1.05', 'groupId': 'OG000'}, {'value': '2.58', 'spread': '0.97', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '1 week after baseline survey', 'description': 'The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'A subset of participants who completed the baseline survey (n=200) were re-contacted approximately 1 week post-survey for a retest. Participants who completed the retest survey and provided enough information to calculate the shared decision making process score were part of this analysis. 163/200 participants provided sufficient information to calculate a retest SDM Process score.'}, {'type': 'SECONDARY', 'title': 'Depression Knowledge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '55.22', 'spread': '22.96', 'groupId': 'OG000'}, {'value': '55.98', 'spread': '21.87', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline survey', 'description': 'Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge', 'unitOfMeasure': 'percentage of correct answers', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed at least 60% of the knowledge questions for their respective cancer screening group. All 494 participants provided sufficient information to calculate a knowledge score.'}, {'type': 'SECONDARY', 'title': 'Adherence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '169', 'groupId': 'OG000'}, {'value': '204', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'OG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'classes': [{'categories': [{'measurements': [{'value': '83.6', 'spread': '18.47', 'groupId': 'OG000'}, {'value': '84.79', 'spread': '18.25', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline survey', 'description': '3 item measure of adherence to medication for sample participants who indicate that they are taking medicine. A total score is calculated with scores ranging form 0-100; higher values indicated greater medication adherence.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'participants who completed all 3 measures of adherence to calculate an adherence score. 373/494 provided sufficient information to calculate an adherence score.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'FG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '230'}, {'groupId': 'FG001', 'numSubjects': '264'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'April 2020 - May 2020 using a national, non-probability panel obtained from Marketing Systems Group (MSG). MSG recruited participants by sending out invitation emails to potential responders.', 'preAssignmentDetails': 'Eligible respondents were adults in the US who had talked with a healthcare provider about starting or stopping medication for depression in the past 12 months. The sample was selected to have approximately equal age distribution above and below 40 years old (e.g. 18-39 and 40-75). Respondents were re-contacted approximately one-week post survey for a re-test survey.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '230', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Original Shared Decision Making Process Scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'id': 'BG001', 'title': 'Revised Shared Decision Making Process Scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '42', 'spread': '14', 'groupId': 'BG000'}, {'value': '44', 'spread': '14', 'groupId': 'BG001'}, {'value': '43', 'spread': '14', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '158', 'groupId': 'BG000'}, {'value': '197', 'groupId': 'BG001'}, {'value': '355', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '72', 'groupId': 'BG000'}, {'value': '66', 'groupId': 'BG001'}, {'value': '138', 'groupId': 'BG002'}]}]}, {'title': 'Non-Binary', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '218', 'groupId': 'BG000'}, {'value': '241', 'groupId': 'BG001'}, {'value': '459', '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 (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '193', 'groupId': 'BG000'}, {'value': '224', 'groupId': 'BG001'}, {'value': '417', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '13', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '230', 'groupId': 'BG000'}, {'value': '264', 'groupId': 'BG001'}, {'value': '494', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'Web-based non-probability panel of respondents aged 18-75 years old who had discussed with their healthcare provider about starting or stopping treatment for depression in the past year. Participants needed to have provided enough information to calculate the shared decision making process score (primary outcome of interest)'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-03-15', 'size': 129985, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-30T08:46', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 494}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-03', 'completionDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-30', 'studyFirstSubmitDate': '2020-04-09', 'resultsFirstSubmitDate': '2022-06-02', 'studyFirstSubmitQcDate': '2020-04-09', 'lastUpdatePostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-03-30', 'studyFirstPostDateStruct': {'date': '2020-04-13', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Shared Decision Making Process Score', 'timeFrame': 'Baseline survey', 'description': 'The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores for both versions of the scale range from 0-4 where higher values indicate a better shared decision making process occurred.'}], 'secondaryOutcomes': [{'measure': 'Decisional Conflict Tool (SURE)', 'timeFrame': 'Baseline survey', 'description': 'Measures decisional conflict, consists of 4 yes/no items. Scores range 0-4 where 0 indicates high decisional conflict, 4 indicates no decisional conflict, and scores less than or equal to 3 indicate decisional conflict. The measure is top-scored and we report the percentage of participants who scored a 4 ("no decisional conflict).'}, {'measure': 'Decision Regret Scale', 'timeFrame': 'Baseline survey', 'description': '5-item decision regret scale ranges from 0-100 with higher scores indicating greater decisional regret.'}, {'measure': 'Single-Item Measure of Decision Regret', 'timeFrame': 'Baseline survey', 'description': 'Single item asking "If you knew then what you know now, do you think you would make the same decision about depression?" Responses are definitely yes, probably yes, probably no and definitely no.'}, {'measure': 'Treatment Preference', 'timeFrame': 'Baseline survey', 'description': 'Single item asking "What did you want to do to manage your depression" with response options (1) Anti-depressant medicine alone, (2) Counseling or therapy alone, (3) Both medicine and counseling, and (4) Do something else.'}, {'measure': 'Adapted Controlled Preference Scale', 'timeFrame': 'Baseline survey', 'description': 'Single item asking the participant who made the ultimate decision. The categorical response options are 1) the patient made the decision, 2)the provider made the decision, or 3) both patient and provider made the decision together.'}, {'measure': 'Shared Decision Making Process Measure Retest', 'timeFrame': '1 week after baseline survey', 'description': 'The Shared Decision Making Process is a short patient-reported survey that measures the amount of shared decision making that occurs in an interaction. Scores range from 0-4 where higher values indicate a better shared decision making process occurred.'}, {'measure': 'Depression Knowledge', 'timeFrame': 'Baseline survey', 'description': 'Multiple choice knowledge items for each topic will be combined to a total knowledge score (0-100) with higher scores indicating higher knowledge'}, {'measure': 'Adherence', 'timeFrame': 'Baseline survey', 'description': '3 item measure of adherence to medication for sample participants who indicate that they are taking medicine. A total score is calculated with scores ranging form 0-100; higher values indicated greater medication adherence.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['shared decision making'], 'conditions': ['Depression']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of reliability, to test whether the generic version has similar psychometric performance to the original, and to extend generalizability of the findings to younger adults.', 'detailedDescription': 'The purpose of this study is to test two differently worded versions of the Shared Decision Making Process scale in a sample of adults who have recently made a decision about treatment of depression. The main goals are to gather evidence of psychometric performance of the scale, compare performance of different wording for items, and to extend generalizability of the findings to younger adults.\n\nSubjects are randomly assigned to one of the two versions of the Shared Decision Making Process scale and complete a set of measures regarding their experiences with decision making for depression, demographics, and health status. A subset of respondents will complete the Shared Decision Making Process scale and selected other items again 1 week later to examine short term test-retest reliability.\n\nStaff will work with a national sampling firm to recruit subjects and obtain 500 responses to the baseline survey (n=250 for each version) and a subset will complete a retest survey (n=200; 50 from each age and survey type group). Eligible subjects are adults aged 18-75 who talked with a health care provider about treatment for depression in the preceding 12 months. The sample is not a national probability sample; however, the recruitment efforts will ensure about 50% of respondents aged 18-39 and 50% aged 40-75, and to ensure at least 25% of the sample is racial/ethnic minorities (Black or African American, Asian, Hispanic or Latino).\n\nThe investigators will examine validity and reliability of the different versions. The sample size was determined to ensure sufficient power to detect differences in key subgroups, including age (younger adults vs. older adults) and version (A vs. B). To detect a difference of about 0.33 standard deviations at 0.05 significance with 80% power would require 125 per group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Sample of adults in the United States who have made decision about treatment of depression in the past 12 months will be recruited from an online panel.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must have spoken to a healthcare provider about treatment for depression in the past 12 months\n* Must have started or stopped medication for depression between January 2018 and their surveyed date.\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT04343534', 'briefTitle': 'Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Online Trial Examining Validity and Reliability of the Shared Decision Making Process Survey in Adults With Depression', 'orgStudyIdInfo': {'id': '2019P001434-2'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Original Shared Decision Making Process scale', 'description': 'Patients receive the original version of the Shared Decision Making Process scale.'}, {'label': 'Revised Shared Decision Making Process scale', 'description': 'This group completes a new version of the scale with different wording for several items.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ANALYTIC_CODE'], 'timeFrame': 'The data will be available to outside investigators starting 6 months after publication.', 'ipdSharing': 'YES', 'description': 'The study team will create a complete, cleaned, de-identified copy of the final data set for each online field test.', 'accessCriteria': 'Information about the data sets will be on the Health Decision Sciences Center website and in publications of the data. Dr. Sepucha will share a de-identified data set with outside investigators at no cost, according to approved Massachusetts General Hospital (MGH)/Partners policies for data sharing. Investigators from other sites will be able to request the data and will be required to complete a data use agreement that ensures that all local Institutional Review Board (IRB) requirements are met before using the data, that they will not attempt to identify any data in the dataset, and that they will not share the data set with anyone outside their project team.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Massachusetts, Boston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director of the Health Decision Sciences Center', 'investigatorFullName': 'Karen Sepucha', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}