Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-26 @ 4:00 PM
Study NCT ID:
NCT05355506
Status:
SUSPENDED
Last Update Posted:
2022-05-02
First Post:
2022-04-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Development and Effectiveness of Heart Failure Self-Health Management Application
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'targetDuration': '8 Weeks', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'covid-19', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2019-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-12-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-29', 'studyFirstSubmitDate': '2022-04-11', 'studyFirstSubmitQcDate': '2022-04-29', 'lastUpdatePostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "participant's knowledge about heart failure significantly increased after the intervention", 'timeFrame': '6 months', 'description': "Provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model. Analysis on participant's knowledge about heart failure and Technology Acceptance Model Scale after the Intervention. Higher scores mean a better outcome."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart Failure'], 'conditions': ['Heart Failure']}, 'descriptionModule': {'briefSummary': 'Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".', 'detailedDescription': 'Abstract Aims: To develop a smartphone application and investigate its effectiveness on patients with heart failure after using the "heart failure self-health management application.".\n\nDesign: The single-group pre- and post-test experimental design was adopted. Methods: This study used convenience sampling and the one-group pretest and posttest design as the research methods and developed the "heart failure self-health management application" using the Google cloud database and Web App. The research period was from July 1 to December 31, 2019, a total of 36 patients diagnosed with heart failure during hospitalization completed the pretest and posttest. This App (1) provides text and video heart failure self-care knowledge content; (2) enables users to record and browse blood pressure, heart rate, and weight; and (3) provides the data from the Dutch Heart Failure Knowledge Scale and Technology Acceptance Model.\n\nKeywords: heart failure; self-health management; application'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Inclusion Criteria:\n\n* Heart failure\n\nExclusion Criteria:\n\n* Health', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Heart failure\n\nExclusion Criteria:\n\n* Health'}, 'identificationModule': {'nctId': 'NCT05355506', 'acronym': 'APP', 'briefTitle': 'The Development and Effectiveness of Heart Failure Self-Health Management Application', 'organization': {'class': 'OTHER', 'fullName': 'National Taipei University of Nursing and Health Sciences'}, 'officialTitle': 'National Taipei University of Nursing and Science', 'orgStudyIdInfo': {'id': '19MMHIS04Oe'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'The Development and Effectiveness of Heart Failure Self-Health Management Application', 'description': 'Heart Failure can cause physical disability and death. According to the Ministry of Health and Welfare, there were 20,644 deaths from heart disease, ranking second among the top 10 causes of death \\[1\\]. The World Health Organization (WHO) has advocated nursing guidance with the concept of "empowerment", where patients can play an active and aggressive role in managing their health \\[2\\]. This paperless nursing health education guidance information can be designed through the application, which features non-professional expressions and visualization methods. The users can participate in feedback-based interactions and complete the questionnaires after receiving nursing guidance. This study used the Technology Acceptance Model (TAM) to evaluate patients\' acceptance of the nursing guidance application and the effectiveness of such nursing guidance.', 'interventionNames': ['Device: Application']}], 'interventions': [{'name': 'Application', 'type': 'DEVICE', 'description': 'Knowledge \\& record', 'armGroupLabels': ['The Development and Effectiveness of Heart Failure Self-Health Management Application']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Taipei County', 'country': 'Taiwan', 'facility': 'Pei-Hung Liao'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taipei University of Nursing and Health Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Pei-Hung Liao', 'investigatorAffiliation': 'National Taipei University of Nursing and Health Sciences'}}}}