Ignite Creation Date:
2025-12-24 @ 7:49 PM
Ignite Modification Date:
2025-12-25 @ 5:26 PM
Study NCT ID:
NCT04892004
Status:
COMPLETED
Last Update Posted:
2021-05-19
First Post:
2021-05-11
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Symptom Recognition Improves Self-care in Patients With Heart Failure.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006333', 'term': 'Heart Failure'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-05-13', 'studyFirstSubmitDate': '2021-05-11', 'studyFirstSubmitQcDate': '2021-05-13', 'lastUpdatePostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Symptom recognition', 'timeFrame': 'up to 3 months', 'description': 'Awareness by a person of the body changes and how they can affect him/her'}, {'measure': 'Self-care behaviors', 'timeFrame': 'up to 3 months', 'description': 'Analyze if self-care behaviors are improved'}, {'measure': 'Emergency and Hospital admissions', 'timeFrame': 'up to 3 months', 'description': 'Report if patients with Heart Failure are admitted into hospital or emergency room'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Heart failure', 'Self-care behaviors', 'Symptom recognition', 'Nurse-led program'], 'conditions': ['Heart Failure', 'Symptoms and Signs']}, 'referencesModule': {'references': [{'pmid': '34968218', 'type': 'DERIVED', 'citation': 'Pereira Sousa J, Neves H, Pais-Vieira M. Does Symptom Recognition Improve Self-Care in Patients with Heart Failure? A Pilot Study Randomised Controlled Trial. Nurs Rep. 2021 Jun 1;11(2):418-429. doi: 10.3390/nursrep11020040.'}]}, 'descriptionModule': {'briefSummary': 'Describe a behaviour intervention to analyse self-care engagement in heart failure patients. Allocate patients with heart failure into 2 arms study: a control group and an intervention group.', 'detailedDescription': 'According to medical record at admission, a pilot study was described and included 63 patients in New York Heart Association (NYHA) functional class II-III. Patients were recruited in a hospital setting after discharge from a heart failure unit.\n\nPatients were allocated into a control group (n=33) and an intervention group (n=30) through the computerised random allocation generator at http://random.org.\n\nThe pilot study was performed during three months per patient, with four moments of assessment (baseline, first-week follow-up, first-month follow-up, third-month follow-up).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adults aged \\>18 years old, with diagnosed HF and with no cognitive disability associated.\n\nExclusion Criteria:\n\n* patients placed on the heart transplant waiting list and patients in class IV NYHA.'}, 'identificationModule': {'nctId': 'NCT04892004', 'briefTitle': 'Symptom Recognition Improves Self-care in Patients With Heart Failure.', 'organization': {'class': 'OTHER', 'fullName': 'Instituto Politécnico de Leiria'}, 'officialTitle': 'Does Symptom Recognition Improve Self-care in Patients With Heart Failure. A Growth Latent Model', 'orgStudyIdInfo': {'id': 'SympRecgHF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Standard information defined as the standard care, unplanned, provided for Heart Failure patients and not personalized.'}, {'type': 'EXPERIMENTAL', 'label': 'Interventional group', 'description': 'A nurse provides the intervention with expertise in Heart Failure and addresses reinforcements on: a) an explanation on signs and symptoms of Heart Failure and how to recognise them; b) importance on daily fluid management, by planning 1.5-2 litres of liquids per day (e.g., soup, milk, coffee, water, tea and yoghurts); and c) when doctors or nurses should be contacted (when symptoms escalation or a weight gain of 2 kg in three days or 5 kg in a week were detected).', 'interventionNames': ['Behavioral: Symptom recognition']}], 'interventions': [{'name': 'Symptom recognition', 'type': 'BEHAVIORAL', 'description': 'The patient receives a leaflet, which includes information about HF, primary symptoms, awareness of its detection and the fluid management plan. It also receives a weight diary, which helps him/her recall weight fluctuation and contact the nurse or doctor to call for help in a previous stage and avoid hospitalisation. Patients have to explain what they understand by HF, on follow-ups contacts, which are the main symptoms, if they are experiencing any of them and which difficulties managing fluid restriction and weight control. The leading investigator validates the information and teaches back contents if required.', 'armGroupLabels': ['Interventional group']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Instituto Politécnico de Leiria', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Joana Sousa', 'investigatorAffiliation': 'Instituto Politécnico de Leiria'}}}}