Ignite Creation Date:
2025-12-26 @ 10:46 PM
Ignite Modification Date:
2026-02-20 @ 3:37 PM
Study NCT ID:
NCT01964612
Status:
UNKNOWN
Last Update Posted:
2013-10-17
First Post:
2013-10-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 460}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'lastUpdateSubmitDate': '2013-10-14', 'studyFirstSubmitDate': '2013-10-08', 'studyFirstSubmitQcDate': '2013-10-14', 'lastUpdatePostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'self-monitoring and self-control scale', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'meta-thinking awareness scale', 'timeFrame': 'one year'}, {'measure': 'negative self thinking scale', 'timeFrame': 'one year'}, {'measure': 'depression and anxiety scale', 'timeFrame': 'one year'}, {'measure': 'life change scale', 'timeFrame': 'one year'}, {'measure': 'health anxiety scale', 'timeFrame': 'one year'}]}, 'conditionsModule': {'conditions': ['Drug or Chemical Induced Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.', 'detailedDescription': 'Patient with chronic disease learning of a chronic illness quickly changes the way they encounter in physiological, psychological and social aspects. They need adjust themselves and their crisis lives, and some plan they had made the near or distant future. The investigators research purposes will use the meta-cognitive approach to explore adjustment to life-threatening illness (ex. hypertension and diabetes) of patients may find the important factors in their coping process.Research methods will separate three year project to describe. First year project will use qualitative methods from bio-psychosocial aspects to interview participants who may suffer illness after diagnosis or stable treatment during middle phase of illness. Second year will invite diabetes and hypertension patients from different phase of illness with different levels of health anxiety trait, meta-cognitive and control strategies if derived different coping and emotions outcome. The third year will design motivational psycho-education program for patients to alleviate the emotions and use cold meta-cognition to due good health behavior and self care with their illness. The expected results will like to test the investigators new model in caring chronic disease patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'adults with obvious chronic diseases of hypertension or diabetes, or both diseases diagnosed by doctors in Taiwan.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults aged 20 and above, with hypertension or diabetes or both diseases.\n\nExclusion Criteria:\n\n* adults with other severe physical diseases.\n* adults with relevant psychological diseases.'}, 'identificationModule': {'nctId': 'NCT01964612', 'briefTitle': 'Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Illness Crisis Adapting in Early or Middle Phase of Patient With Chronic Disease: Study of Meta-cognition Model', 'orgStudyIdInfo': {'id': '201205106RIC'}}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'state': 'Taiwan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Bee-Horng Lue, MD', 'role': 'CONTACT', 'email': 'grace@ntu.edu.tw', 'phone': '886-2-23123456'}], 'facility': 'National Taiwan University Hopital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Bee-Horng Lue, MD', 'role': 'CONTACT', 'email': 'grace@ntu.edu.tw', 'phone': '886-2-23123456'}], 'overallOfficials': [{'name': 'Bee-Horng Lue, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'National Taiwan University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}