Ignite Creation Date:
2025-12-25 @ 12:54 AM
Ignite Modification Date:
2025-12-26 @ 1:53 PM
Study NCT ID:
NCT04210167
Status:
COMPLETED
Last Update Posted:
2024-08-12
First Post:
2019-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'This study is a randomized controlled study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-09', 'studyFirstSubmitDate': '2019-12-19', 'studyFirstSubmitQcDate': '2019-12-21', 'lastUpdatePostDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Has an effect on reducing symptom burden', 'timeFrame': '3 months', 'description': 'Memorial Symptom Assessment Scale-Heart Failure: The Memorial Symptom Assessment Scale-Heart Failure was used to evaluate symptom prevalence, severity, and distress. For each of the 32 items, the patient indicated whether he/she had experienced the symptom by selecting "yes" or "no." If "yes" was selected, the severity of a symptom over the past 7 days was assessed using the response. The score range of each symptom is 0-4. Higher score indicates a higher symptom burden. Turkish version of the questionnaire was used.'}, {'measure': 'Has an effect on improving quality of life', 'timeFrame': '3 months', 'description': 'Left Ventricular Dysfunction Questionnaire: The questionnaire is a 36 item questionnaire for patients with left ventricular dysfunction. Responses are dichotomous (true or false). True responses are summed and the sum is expressed as a percentage. The score range of scale is 0-100. A higher score indicates a worse quality of life. Turkish version of the questionnaire was used.'}, {'measure': 'Reducing heart failure patient rehospitalizations', 'timeFrame': '3 months', 'description': 'Evaluation form of rehospitalizations: During the 3-month follow-up period, the number of admissions to the hospital and emergency outpatient clinic was recorded. In addition, if he was hospitalized, how many days he was hospitalized was recorded.'}, {'measure': 'Positive effects on waist circumference', 'timeFrame': '3 months', 'description': 'Waist circumference assessment form: The form was prepared by the researcher to record the waist circumference of the patients as "centimeters" unit.'}, {'measure': 'Positive effects on weight', 'timeFrame': '3 months', 'description': 'Weight assessment form: The form was prepared by the researcher to record the patients\' weights in "kilogram" units.'}, {'measure': 'Positive effects on blood pressure', 'timeFrame': '3 months', 'description': 'Blood pressure assessment form: The form was prepared by the researcher to record the blood pressure of the patients as "mmHg" units'}, {'measure': 'Positive effects on creatinine', 'timeFrame': '3 months', 'description': 'Creatinine assessment form: A form was prepared by the researcher to record normal creatinine levels in the blood as "milligram" units.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['heart failure', 'web-based training', 'telephone monitoring', 'symptom assessment', 'quality of life'], 'conditions': ['Heart Failure', 'Patient', 'Quality of Life', 'Symptoms']}, 'referencesModule': {'references': [{'pmid': '26307539', 'type': 'BACKGROUND', 'citation': 'Piamjariyakul U, Werkowitch M, Wick J, Russell C, Vacek JL, Smith CE. Caregiver coaching program effect: Reducing heart failure patient rehospitalizations and improving caregiver outcomes among African Americans. Heart Lung. 2015 Nov-Dec;44(6):466-73. doi: 10.1016/j.hrtlng.2015.07.007. Epub 2015 Aug 22.'}, {'pmid': '27894487', 'type': 'BACKGROUND', 'citation': 'Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GMC, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P. 2016 ESC Guidelines for the Diagnosis and Treatment of Acute and Chronic Heart Failure. Rev Esp Cardiol (Engl Ed). 2016 Dec;69(12):1167. doi: 10.1016/j.rec.2016.11.005. No abstract available. English, Spanish.'}, {'pmid': '23787723', 'type': 'BACKGROUND', 'citation': 'Seferovic PM, Stoerk S, Filippatos G, Mareev V, Kavoliuniene A, Ristic AD, Ponikowski P, McMurray J, Maggioni A, Ruschitzka F, van Veldhuisen DJ, Coats A, Piepoli M, McDonagh T, Riley J, Hoes A, Pieske B, Dobric M, Papp Z, Mebazaa A, Parissis J, Ben Gal T, Vinereanu D, Brito D, Altenberger J, Gatzov P, Milinkovic I, Hradec J, Trochu JN, Amir O, Moura B, Lainscak M, Comin J, Wikstrom G, Anker S; Committee of National Heart Failure Societies or Working Groups of the Heart Failure Association of the European Society of Cardiology. Organization of heart failure management in European Society of Cardiology member countries: survey of the Heart Failure Association of the European Society of Cardiology in collaboration with the Heart Failure National Societies/Working Groups. Eur J Heart Fail. 2013 Sep;15(9):947-59. doi: 10.1093/eurjhf/hft092. Epub 2013 Jun 19.'}, {'pmid': '25628261', 'type': 'BACKGROUND', 'citation': 'Wakefield B, Pham K, Scherubel M. Usability Evaluation of a Web-Based Symptom Monitoring Application for Heart Failure. West J Nurs Res. 2015 Jul;37(7):922-34. doi: 10.1177/0193945914568813. Epub 2015 Jan 26.'}, {'pmid': '28045703', 'type': 'BACKGROUND', 'citation': 'Wakefield BJ, Alexander G, Dohrmann M, Richardson J. Design and Evaluation of a Web-Based Symptom Monitoring Tool for Heart Failure. Comput Inform Nurs. 2017 May;35(5):248-254. doi: 10.1097/CIN.0000000000000324.'}, {'pmid': '28461259', 'type': 'BACKGROUND', 'citation': 'Yancy CW, Jessup M, Bozkurt B, Butler J, Casey DE Jr, Colvin MM, Drazner MH, Filippatos GS, Fonarow GC, Givertz MM, Hollenberg SM, Lindenfeld J, Masoudi FA, McBride PE, Peterson PN, Stevenson LW, Westlake C. 2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure: A Report of the American College of Cardiology/American Heart Association Task Force on Clinical Practice Guidelines and the Heart Failure Society of America. J Card Fail. 2017 Aug;23(8):628-651. doi: 10.1016/j.cardfail.2017.04.014. Epub 2017 Apr 28. No abstract available.'}, {'pmid': '15916924', 'type': 'BACKGROUND', 'citation': 'Zambroski CH, Moser DK, Bhat G, Ziegler C. Impact of symptom prevalence and symptom burden on quality of life in patients with heart failure. Eur J Cardiovasc Nurs. 2005 Sep;4(3):198-206. doi: 10.1016/j.ejcnurse.2005.03.010.'}], 'seeAlsoLinks': [{'url': 'http://www.heart.org/HEARTORG/Conditions/HeartFailure/WarningSignsforHeartFailure/W', 'label': 'American Heart Association, Warning Signs of Heart Failure'}]}, 'descriptionModule': {'briefSummary': 'Web-based training and telephone monitoring have an effect on reducing symptom burden in patients with heart failure.\n\nWeb-based training and telephone monitoring have an effect on improving the quality of life of patients with heart failure.\n\nWeb-based training and telephone follow-up have an effect on reducing recurrent hospitalizations of patients with heart failure.\n\nWeb-based training and telephone follow-up have a positive effect on the clinical parameters (weight, waist circumference, blood pressure, creatinine) of patients with heart failure.', 'detailedDescription': 'The aim of this study was to determine the effect of web-based training and telephone monitoring on symptom management and quality of life in patients with heart failure. Study was conducted with the participation of 32 intervention and 32 control patients who have heart failure, in Akdeniz University Hospital Cardiology Clinic, between April 2018 and July 2019. Data were collected using the Patient Information Form, Left Ventricular Dysfunction Scale and Memorial Symptom Rating Scale-Heart Failure Scale, Website Analysis and Measurement Inventory. The patients in the intervention group received web-based training after discharge, and were followed up by telephone at the first, fourth, eighth and 12 weeks. The scale data were collected before the patient was discharged from hospital and at the third month of discharge.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Undergoing treatment at the Cardiology Clinic of Akdeniz University Hospital with a diagnosis of heart failure.\n* Class I, II, III according to NYHA classification\n* Has internet access and can use a computer / tablet or smartphone\n* Agree to participate in the research\n\nExclusion Criteria:\n\n* Functional class IV according to NYHA classification\n* Diagnosed with psychiatric illness\n* Malignancy diagnosed\n* Visually and hearing impaired\n* Diagnosed with chronic obstructive pulmonary disease'}, 'identificationModule': {'nctId': 'NCT04210167', 'briefTitle': 'Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial', 'organization': {'class': 'OTHER', 'fullName': 'Akdeniz University'}, 'officialTitle': 'Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'Akdeniz University 07'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'web-based training and telephone monitoring', 'description': 'The heart failure patients in the intervention group were given web-based training for three months after discharge and followed up by telephone at the first, fourth, eighth and 12th weeks. At the same time, a text message was sent once a week. Scale data were collected before the patient was discharged from the hospital and at the third month of discharge.', 'interventionNames': ['Behavioral: web-based training and telephone monitoring']}], 'interventions': [{'name': 'web-based training and telephone monitoring', 'type': 'BEHAVIORAL', 'description': 'web-based training and telephone monitoring and short message', 'armGroupLabels': ['web-based training and telephone monitoring']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antalya', 'country': 'Turkey (Türkiye)', 'facility': 'Akdeniz University', 'geoPoint': {'lat': 36.90812, 'lon': 30.69556}}], 'overallOfficials': [{'name': 'Zeynep ÖZER, PhD, RN', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Akdeniz University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'starting 1 months after publication', 'ipdSharing': 'YES', 'description': 'All collected IPD will share', 'accessCriteria': 'all people access'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Akdeniz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'lecturer', 'investigatorFullName': 'Emine İLASLAN', 'investigatorAffiliation': 'Akdeniz University'}}}}