Ignite Creation Date:
2025-12-24 @ 12:05 PM
Ignite Modification Date:
2025-12-27 @ 9:21 PM
Study NCT ID:
NCT07030361
Status:
COMPLETED
Last Update Posted:
2025-06-22
First Post:
2025-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Intradıalytıc Weıght Control In Hemodıalysıs Patıents
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004487', 'term': 'Edema'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D000079102', 'term': 'Empowerment'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D012919', 'term': 'Social Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D012681', 'term': 'Sensitivity Training Groups'}, {'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D011615', 'term': 'Psychotherapy, Group'}, {'id': 'D012960', 'term': 'Socioenvironmental Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Research data were collected in 3 stages: pretest (Z0), posttest (Z1) and follow-up test (Z2).'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-02-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-12', 'studyFirstSubmitDate': '2025-04-17', 'studyFirstSubmitQcDate': '2025-06-12', 'lastUpdatePostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'intradialytic fluid balance', 'timeFrame': '8 weeks', 'description': 'weight gained during the intradialytic period'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['FluidControl', 'Compliance', 'Empowerment', 'İnnovation', 'DialysisSuit;'], 'conditions': ['Fluid Overload']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://tez.yok.gov.tr/UlusalTezMerkezi/tezSorguSonucYeni.jsp', 'label': 'national thesis center'}]}, 'descriptionModule': {'briefSummary': 'The aim of this observational study is to determine the effect of a dialysis gown designed according to the empowerment model on changes in weight control behaviors among gown group patients during the intradialytic period. The main question it seeks to answer is:\n\n• Is the dialysis gown effective in helping gown group patients control their fluid intake during the intradialytic period?', 'detailedDescription': 'In this study, researchers designed a study to compare whether the behavior of controlling excessive fluid intake during the intradialytic period was better in the group of patients wearing dialysis garments designed according to the empowerment model than in the education and control groups. For this randomized controlled study, patients were divided into three groups. The patients were named the garment group, the education group, and the control group. In the study design, patients underwent garment application and education application. In the garment application, the amount of excess fluid removed by ultrafiltration during that dialysis session was placed in the pockets of the serum dialysis garment, and patients were asked to walk in a 10-meter walking test area. In the education application, a video-based education program designed to teach fluid compliance behavior was implemented. Patients were asked to watch this video education program for an average of half an hour at the beginning of each session.\n\nPatients in the garment group were dressed in dialysis garments and shown the educational video. Patients in the education group were only shown the fluid compliance video. No intervention specific to the study was performed on patients in the control group. All patients continued to receive the normal follow-up and care protocol required for hemodialysis treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Turkish-speaking\n* Turkish-understanding\n* Older than 18 years of age\n* Without communication barriers such as visual and hearing impairment\n* Non-hypotensive and non-anemic patients\n* With an intradialytic weight of 2-5 liters\n* Receiving hemodialysis treatment for more than three months and outpatients\n\nExclusion Criteria:\n\n* Patients who had previously received fluid restriction compliance training\n* Who refused to participate in the study\n* Who had undergone surgery within the last six weeks'}, 'identificationModule': {'nctId': 'NCT07030361', 'acronym': 'DialysisSuit', 'briefTitle': 'Intradıalytıc Weıght Control In Hemodıalysıs Patıents', 'organization': {'class': 'OTHER', 'fullName': 'Balikesir University'}, 'officialTitle': 'Innovative Dialaysis Suit for Hemodialysis Patients Effect of Fluid Restriction on Compliance and Level of Empowerment: Randomise Controlled Trials', 'orgStudyIdInfo': {'id': 'BalikesirUniversity HealtScien'}, 'secondaryIdInfos': [{'id': '222S306', 'type': 'OTHER_GRANT', 'domain': 'TÜBİTAK'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'suits group', 'description': 'Dialysis suit group was dressed in dialysis suit and given fluid control training', 'interventionNames': ['Behavioral: suit group']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2 training group', 'description': 'Fluid control training was given to the traininig group', 'interventionNames': ['Behavioral: training group']}, {'type': 'OTHER', 'label': 'control group', 'description': 'Control group received no intervention, clinical care', 'interventionNames': ['Behavioral: control group']}], 'interventions': [{'name': 'suit group', 'type': 'BEHAVIORAL', 'description': 'elbise giydirme ve video izletme uygulaması', 'armGroupLabels': ['suits group']}, {'name': 'training group', 'type': 'BEHAVIORAL', 'description': 'video izletme uygulaması', 'armGroupLabels': ['2 training group']}, {'name': 'control group', 'type': 'BEHAVIORAL', 'description': 'rutin hemş bakımı uygulaması, herhangi bir müdahale yok', 'armGroupLabels': ['control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10145', 'city': 'Balıkesir', 'country': 'Turkey (Türkiye)', 'facility': 'Balikesir University', 'geoPoint': {'lat': 39.64917, 'lon': 27.88611}}], 'overallOfficials': [{'name': 'Alper Azak, Asist Prof', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'balikesir'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'the product used in the research has not yet entered the production phaset'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Balikesir University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'asist proff', 'investigatorFullName': 'Türkan Çalışkan', 'investigatorAffiliation': 'Balikesir University'}}}}