Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-03 @ 7:21 AM
Study NCT ID:
NCT02076256
Status:
UNKNOWN
Last Update Posted:
2014-10-10
First Post:
2014-02-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'releaseDate': '2022-04-13', 'unreleaseDate': '2022-04-24'}, {'releaseDate': '2022-04-27', 'unreleaseDate': '2022-05-03'}, {'releaseDate': '2022-05-17', 'unreleaseDate': '2022-08-03'}, {'releaseDate': '2022-08-04', 'unreleaseDate': '2022-08-06'}, {'resetDate': '2023-07-07', 'releaseDate': '2022-08-06'}, {'resetDate': '2024-02-22', 'releaseDate': '2023-07-13'}], 'estimatedResultsFirstSubmitDate': '2022-04-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D051436', 'term': 'Renal Insufficiency, Chronic'}], 'ancestors': [{'id': 'D051437', 'term': 'Renal Insufficiency'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 250}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-10', 'lastUpdateSubmitDate': '2014-10-09', 'studyFirstSubmitDate': '2014-02-21', 'studyFirstSubmitQcDate': '2014-02-27', 'lastUpdatePostDateStruct': {'date': '2014-10-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-03-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Helping Relationship Scale', 'timeFrame': 'First year'}, {'measure': 'Health Promotion Lifestyle Profile', 'timeFrame': 'First year', 'description': 'Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).'}, {'measure': 'World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)', 'timeFrame': 'First year', 'description': 'The study will use WHOQOL-BREF to measure the outcome.'}, {'measure': 'International Physical Activity Questionnaire Taiwan Version', 'timeFrame': 'First year', 'description': 'The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.'}, {'measure': 'Helping Relationship Scale', 'timeFrame': 'Second year'}, {'measure': 'Health Promotion Lifestyle Profile', 'timeFrame': 'Second year', 'description': 'Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).'}, {'measure': 'World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)', 'timeFrame': 'Second year', 'description': 'The study will use WHOQOL-BREF to measure the outcome.'}, {'measure': 'International Physical Activity Questionnaire Taiwan Version', 'timeFrame': 'Second year', 'description': 'The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.'}, {'measure': 'Helping Relationship Scale', 'timeFrame': 'The third year'}, {'measure': 'Health Promotion Lifestyle Profile', 'timeFrame': 'The third year', 'description': 'Health promotion was measured by 52 item health promotion lifestyle profileⅡ ( HPLP-II).'}, {'measure': 'World Health Organization Quality of Life (WHOQOL-BREF) with the Short-Form 36 (SF-36)', 'timeFrame': 'The third year', 'description': 'The study will use WHOQOL-BREF to measure the outcome.'}, {'measure': 'International Physical Activity Questionnaire Taiwan Version', 'timeFrame': 'The third year', 'description': 'The study will use International Physical Activity Questionnaire (IPAQ) Taiwan version to measure the outcome.'}, {'measure': 'body weight', 'timeFrame': 'six months'}, {'measure': 'Waist to Hip Ratio', 'timeFrame': 'six months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['helping relationships, healthy lifestyle, quality of life'], 'conditions': ['Chronic Kidney Diseases']}, 'descriptionModule': {'briefSummary': 'Helping relationships from significant others may assist patients with chronic kidney diseases to exercise health behaviors. Patients will adhere on the suggestions from medical staff and perform health lifestyle to maintain healthy behavior. The progress of the disease may be delayed.\n\nThe research is a 3-year study to explore the influence of helping relationships on healthy behaviors among patients with chronic kidney disease. Building on the findings from the past three years study and the literature on trans-theoretical Model, helping relationships will be articulated. A helping relation intervention will be applied to evaluate its effect on healthy lifestyle and quality of life.\n\nThe first year study will be a survey design. An instrument to measure the helping relationship will be established and tested. Total of 200 participants will be recruited to test the reliability and validity of the instrument. After evaluating the psychometric properties of the instrument, items may be revised according to the results. The second year of research will be a cross-section study. Of 250 subjects will be recruited to explore the correlations between helping relationships, healthy life styles, and quality of life. Data will be analyzed using hierarchical linear regression. In the third year, an experimental design will be applied to test the effect of a helping relationship intervention. One hundred and twenty subjects will be recruited and randomly assigned to the experimental and the control group for 60 subjects in each group. The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 20 years and older\n* diagnosed with chronic kidney disease stage 1 to 4 or GFR≧30ml/min/1.73m2\n* patients who has significant others\n* patients who can speak Mandarin or Taiwanese\n\nExclusion criteria:\n\n* Patient who limited to exercise'}, 'identificationModule': {'nctId': 'NCT02076256', 'briefTitle': 'The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng Kung University'}, 'officialTitle': 'The Influence of Helping Relationships From Significant Others on Healthy Lifestyle and Quality of Life Among Patients With Chronic Kidney Disease: A Longitudinal Study', 'orgStudyIdInfo': {'id': 'NSC102-2314-B-006-013-MY3'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group'}, {'type': 'EXPERIMENTAL', 'label': 'The helping relationships intervention program', 'description': 'The helping relationships intervention program will be implemented on the experimental group. And the control group will be provided with routine nursing care. Data will be collected at baseline, the sixth and the ninth month of the third year of study. Data will be analyzed using generalized estimating equation measures to evaluate the effect of the intervention program.', 'interventionNames': ['Behavioral: The helping relationships intervention program']}], 'interventions': [{'name': 'The helping relationships intervention program', 'type': 'BEHAVIORAL', 'armGroupLabels': ['The helping relationships intervention program']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tainan', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Miaofen Yen, Doctor', 'role': 'CONTACT', 'email': 'miaofen@mail.ncku.edu.tw', 'phone': '886-6-2353535', 'phoneExt': '5823'}, {'name': 'Miaofen Yen, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'National Cheng Kung University', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'centralContacts': [{'name': 'Miaofen Yen', 'role': 'CONTACT', 'email': 'miaofen@mail.ncku.edu.tw', 'phone': '+886-6-2353535', 'phoneExt': '5823'}], 'overallOfficials': [{'name': 'Miaofen Yen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng Kung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng Kung University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, {'name': 'E-DA Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD, RN, FAAN', 'investigatorFullName': 'Miaofen Yen', 'investigatorAffiliation': 'National Cheng Kung University'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2022-04-13', 'type': 'RELEASE'}, {'date': '2022-04-24', 'type': 'UNRELEASE'}, {'date': '2022-04-27', 'type': 'RELEASE'}, {'date': '2022-05-03', 'type': 'UNRELEASE'}, {'date': '2022-05-17', 'type': 'RELEASE'}, {'date': '2022-08-03', 'type': 'UNRELEASE'}, {'date': '2022-08-04', 'type': 'RELEASE'}, {'date': '2022-08-06', 'type': 'UNRELEASE'}, {'date': '2022-08-06', 'type': 'RELEASE'}, {'date': '2023-07-07', 'type': 'RESET'}, {'date': '2023-07-13', 'type': 'RELEASE'}, {'date': '2024-02-22', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Miaofen Yen, PhD, RN, FAAN, National Cheng Kung University'}}}}