Ignite Creation Date:
2025-12-24 @ 1:37 PM
Ignite Modification Date:
2026-02-20 @ 6:34 PM
Study NCT ID:
NCT03261895
Status:
COMPLETED
Last Update Posted:
2018-07-20
First Post:
2017-08-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2017-08-21', 'studyFirstSubmitQcDate': '2017-08-24', 'lastUpdatePostDateStruct': {'date': '2018-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-08-25', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-management', 'timeFrame': 'Baseline (T0)', 'description': 'self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.'}, {'measure': 'Self-management', 'timeFrame': 'Immediately post-intervention (T1)', 'description': 'self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.'}, {'measure': 'Self-management', 'timeFrame': 'Three months post-intervention (T2)', 'description': 'self-management refers to the efforts patients actively take to appropriately manage their daily life in order to gain optimal disease control, health status, and quality of life. Self-management was measured using the Summary of Diabetes Self-Care Activities (SDSCA) in this study.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '35932073', 'type': 'DERIVED', 'citation': 'Yu X, Chau JPC, Huo L, Li X, Wang D, Wu H, Zhang Y. The effects of a nurse-led integrative medicine-based structured education program on self-management behaviors among individuals with newly diagnosed type 2 diabetes: a randomized controlled trial. BMC Nurs. 2022 Aug 5;21(1):217. doi: 10.1186/s12912-022-00970-7.'}]}, 'descriptionModule': {'briefSummary': 'This randomized controlled trial aims to investigate the effectiveness of an integrative medicine (traditional Chinese medicine and western medicine) based structured education programme for newly diagnosed type 2 diabetes patients. The theoretical frame of this study is based on the health belief model and self efficacy theory. The hypotheses of this study are: 1) Participants in the intervention group will have higher level of self-management behaviour after intervention compared to participants in the control group; 2) Participants in the intervention group will have better diabetes knowledge after intervention compared to participants in the control group; 3) Participants in the intervention group will have higher level of self-efficacy after intervention compared to participants in the control group; 4) Participants in the intervention group will be less depressed after intervention compared to participants in the control group; 5) Participants in the intervention group will have better QOL after intervention compared to participants in the control group; 6) Participants in the intervention group will gain greater reduction in HbA1c after intervention compared to participants in the control group; 7) Participants in the intervention group will gain greater reduction in fasting blood glucose after intervention compared to participants in the control group; 8) Participants in the intervention group will gain greater reduction in BP after intervention compared to participants in the control group; 9) Participants in the intervention group will gain greater reduction in BMI after intervention compared to participants in the control group.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* individuals diagnosed with type 2 diabetes in the preceding six months\n* individuals aged ≥ 18 years\n* individuals who were permanent residents of Xi'an City, China\n* individuals without mental disorders\n* individuals who were voluntary to participate in the study\n\nExclusion criteria:\n\n* individuals with a terminal illness\n* individuals who were physically disabled\n* individuals who were taking part in other studies\n* individuals with aural or visual problems"}, 'identificationModule': {'nctId': 'NCT03261895', 'acronym': 'NIHaW', 'briefTitle': 'Effectiveness of a Nurse-led Integrative Health and Wellness Programme Among Newly Diagnosed Type 2 Diabetes Patients', 'organization': {'class': 'OTHER', 'fullName': 'Chinese University of Hong Kong'}, 'officialTitle': 'Effectiveness of a Nurse-led Integrative Health and Wellness (NIHaW) Programme on Behavioural, Psychosocial and Biomedical Outcomes Among Individuals With Newly Diagnosed Type 2 Diabetes: A Randomised Controlled Trial', 'orgStudyIdInfo': {'id': 'NIHaW'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'Nurse-led Integrative health and wellness programme', 'interventionNames': ['Behavioral: Nurse-led Integrative health and wellness programme']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'usual diabetes care'}], 'interventions': [{'name': 'Nurse-led Integrative health and wellness programme', 'type': 'BEHAVIORAL', 'description': 'Participants in the intervention group will go through a eight-session structured education programme. The education programme was designed by incorporating the evidences of diabetes care from the western medicine and the philosophy of traditional Chinese medicine.', 'armGroupLabels': ['Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'city': "Xi'an", 'country': 'China', 'facility': "The First Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'country': 'China', 'facility': "The Second Affiliated Hospital of Xi'an Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'country': 'China', 'facility': "The Shaanxi Provincial People's Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': "Xi'an", 'country': 'China', 'facility': "Xi'an Central Hospital", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}], 'overallOfficials': [{'name': 'Xingfeng YU', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Chinese University of Hong Kong'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese University of Hong Kong', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Graduate Assistant', 'investigatorFullName': 'YU Xingfeng', 'investigatorAffiliation': 'Chinese University of Hong Kong'}}}}