Ignite Creation Date:
2025-12-24 @ 11:44 PM
Ignite Modification Date:
2025-12-25 @ 9:36 PM
Study NCT ID:
NCT03324451
Status:
COMPLETED
Last Update Posted:
2020-09-16
First Post:
2017-08-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
The Effectiveness of Intervention on Insulin Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'wrhsia@kmu.edu.tw', 'phone': '886-3-3121101', 'title': 'Ruey-Hsia Wang', 'phoneExt': '2641', 'organization': 'College of Nursing,Kaohsiung Medical University'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'the adverse event data were collected at 12 months after intervention', 'eventGroups': [{'id': 'EG000', 'title': 'TTA Intervention', 'description': 'The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management.', 'otherNumAtRisk': 97, 'deathsNumAtRisk': 97, 'otherNumAffected': 0, 'seriousNumAtRisk': 97, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Control Arm', 'description': 'Participants in the control arm receives regular patient education.', 'otherNumAtRisk': 54, 'deathsNumAtRisk': 54, 'otherNumAffected': 0, 'seriousNumAtRisk': 54, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Glycosylated Hemoglobin (HbA1c) Levels', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.47', 'spread': '2.23', 'groupId': 'OG000'}, {'value': '-2.00', 'spread': '2.29', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels', 'unitOfMeasure': 'percent of glycosylated Hb', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Empowerment Process', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.52', 'spread': '12.13', 'groupId': 'OG000'}, {'value': '-2.13', 'spread': '10.99', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'A 13-item Chinese version of the Diabetes Empowerment Process Scale was used to assess the perceived level of empowerment by healthcare providers in participants. Each item was rated on a 5-point scale with scores ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range from 13 to 65. A higher score indicated higher perceived patient empowerment.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Diabetes Distress', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '-2.91', 'spread': '8.16', 'groupId': 'OG000'}, {'value': '-3.63', 'spread': '6.76', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'An 8-item Chinese version of the short-form Problem Areas in Diabetes Scale was used to assess the levels of diabetes distress in participants. The response of each item was rated from 0 (not a problem) to 4 (serious problem). The total score ranged from 8 to 32. A higher score represented severer diabetes distress.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Quality of Life', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '2.6', 'spread': '7.51', 'groupId': 'OG000'}, {'value': '5.45', 'spread': '10.86', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'A 15-item Diabetes-Specific Quality-of-Life Scale was used to assess the subjective appraisal of participants in their perceived degree to which their current health-related aspects in life were affected by emotional suffering, social functioning, adherence to treatment regimen, and diabetic-specific symptoms. Each item was rated from "very much" (0 point) to "not at all" (4 points). The total score ranged from 0 to 60. A higher score indicated better quality of life.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Body Mass Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '41', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'OG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.06', 'spread': '1.61', 'groupId': 'OG000'}, {'value': '0.85', 'spread': '1.81', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'Physiological parameter which will be collected from body weight scale and height scale, and will be converted to body mass index (weight (kg)/ height(m) 2', 'unitOfMeasure': 'Kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'FG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '97'}, {'groupId': 'FG001', 'numSubjects': '54'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '65'}, {'groupId': 'FG001', 'numSubjects': '41'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '13'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Intervention Arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains three parts: (1) individual intervention; (2) insulin injection follow-up management\n\nTTM Intervention for Insulin Initiation: The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.'}, {'id': 'BG001', 'title': 'Control Arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.\n\nUsual care: Regular patient education on insulin injection at the control arm hospital.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '25', 'groupId': 'BG001'}, {'value': '63', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '27', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '43', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'some participants were lost'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '60.91', 'spread': '14.30', 'groupId': 'BG000'}, {'value': '60.02', 'spread': '11.49', 'groupId': 'BG001'}, {'value': '60.57', 'spread': '13.24', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'some participants were lost follow-up'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'BG000'}, {'value': '41', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '23', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '53', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'some participants were lost follow-up'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Taiwan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '97', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '97', 'groupId': 'BG000'}, {'value': '54', 'groupId': 'BG001'}, {'value': '151', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2017-10-18', 'size': 789631, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2017-10-24T04:06', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Patients with T2DM at a clinic in southern Taiwan are assigned to the intervention arm, whereas patients with T2DM at the endocrinology department of a hospital in northern Taiwan are placed in the control arm. Eligible patients that match the inclusion criteria are recommended by doctors to initiate insulin treatment. Research assistants will explain the objectives of this study to eligible participants. Subsequently, baseline data will be collected from participants by research assistants after the participants sign the consent forms. Afterwards, the participants in the intervention arm will receive the intervention. For the control arm, the participants will receive regular patient education originally administered at the hospital.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 151}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-14', 'studyFirstSubmitDate': '2017-08-29', 'resultsFirstSubmitDate': '2020-06-17', 'studyFirstSubmitQcDate': '2017-10-24', 'lastUpdatePostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-09-14', 'studyFirstPostDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-09-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Glycosylated Hemoglobin (HbA1c) Levels', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'Collected from blood test to assess the Glycosylated hemoglobin (HbA1c) levels'}], 'secondaryOutcomes': [{'measure': 'Change in Diabetes Empowerment Process', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'A 13-item Chinese version of the Diabetes Empowerment Process Scale was used to assess the perceived level of empowerment by healthcare providers in participants. Each item was rated on a 5-point scale with scores ranging from 0 (strongly disagree) to 4 (strongly agree). The total score range from 13 to 65. A higher score indicated higher perceived patient empowerment.'}, {'measure': 'Change in Diabetes Distress', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'An 8-item Chinese version of the short-form Problem Areas in Diabetes Scale was used to assess the levels of diabetes distress in participants. The response of each item was rated from 0 (not a problem) to 4 (serious problem). The total score ranged from 8 to 32. A higher score represented severer diabetes distress.'}, {'measure': 'Change in Quality of Life', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'A 15-item Diabetes-Specific Quality-of-Life Scale was used to assess the subjective appraisal of participants in their perceived degree to which their current health-related aspects in life were affected by emotional suffering, social functioning, adherence to treatment regimen, and diabetic-specific symptoms. Each item was rated from "very much" (0 point) to "not at all" (4 points). The total score ranged from 0 to 60. A higher score indicated better quality of life.'}, {'measure': 'Change in Body Mass Index', 'timeFrame': 'At baseline and 12 months after the intervention', 'description': 'Physiological parameter which will be collected from body weight scale and height scale, and will be converted to body mass index (weight (kg)/ height(m) 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the effectiveness of an intervention for insulin injection initiation based on the Transtheoretical Model (TTM) for insulin-naïve patients with type 2 diabetes mellitus (T2DM).', 'detailedDescription': 'According to the Transtheoretical Model (TTM) proposed by Prochaska and Diclemente, people will experience different stages of change before the actual behavioral change takes place. Ineffectiveness of intervention to instigate behavioral change is largely due to failure to take into account the stage of change in which individuals are. The TTM suggests that decisional balance, which reflects the relative difference between pros and cons, is important for influencing the stage of change. In order to achieve behavioral change, the perceived pros of changing must be strengthened to outweigh the cons. In addition, individual must be self-convinced that the behavioral change is important for themselves. Furthermore, the process for behavioral change can be provided to facilitate behavioral change in individuals. The theory of TTM has yet been used to improve the behavior of insulin initiation in insulin-naïve patients with T2DM. Thus, this study aims to assess the effectiveness of an intervention for insulin injection initiation based on the TTM in insulin-naïve patients with T2DM.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(1) diagnosed with T2DM for at least half a year; (2) aged 20-70 years old; (3) controlling diabetes only through oral medication, without previous experience in insulin injection; (4) HbA1c≧8.5% as measured more than twice in a year; (5) considered suitable and recommended by the doctor to initiate insulin injection.\n\nExclusion Criteria:\n\n(1) unable to communicate with language; (2) incapable of self-administering insulin injection due to visual or muscular impairment.'}, 'identificationModule': {'nctId': 'NCT03324451', 'briefTitle': 'The Effectiveness of Intervention on Insulin Injection', 'organization': {'class': 'OTHER', 'fullName': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}, 'officialTitle': 'The Effectiveness of Intervention on Insulin Injection in Insulin-naive Patients With Type 2 Diabetes: Application of the Transtheoretical Model', 'orgStudyIdInfo': {'id': 'KMUHIRB-E(I)-20150262'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'The arm that receives "TTM Intervention for Insulin Initiation." The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management', 'interventionNames': ['Behavioral: TTM Intervention for Insulin Initiation']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control arm', 'description': 'The arm that receives usual care from the hospital that hosts the control arm. Participants in the control arm receives regular patient education.', 'interventionNames': ['Behavioral: Usual care']}], 'interventions': [{'name': 'TTM Intervention for Insulin Initiation', 'type': 'BEHAVIORAL', 'description': 'The intervention contains two parts: (1) individual intervention; (2) insulin injection follow-up management. Different intervention strategies are applied to patients according to their stages of change.', 'armGroupLabels': ['Intervention arm']}, {'name': 'Usual care', 'type': 'BEHAVIORAL', 'description': 'Regular patient education on insulin injection at the control arm hospital.', 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '807', 'city': 'Kaohsiung City', 'country': 'Taiwan', 'facility': "Lee's clinic", 'geoPoint': {'lat': 22.61626, 'lon': 120.31333}}], 'overallOfficials': [{'name': 'Ruey-Hsia Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Kaohsiung Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kaohsiung Medical University Chung-Ho Memorial Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ruey-Hsia Wang, PhD', 'investigatorAffiliation': 'Kaohsiung Medical University Chung-Ho Memorial Hospital'}}}}