- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04210167
The Effect of Web-based Training and Telephone Monitoring on Patients With Heart Failure
The Effect of Web Based Training and Telephone Follow-up on Symptom Management and Quality of Life in Patients With Heart Failure
Web-based training and telephone monitoring have an effect on reducing symptom burden in patients with heart failure.
Web-based training and telephone monitoring have an effect on improving the quality of life of patients with heart failure.
Web-based training and telephone follow-up have an effect on reducing recurrent hospitalizations of patients with heart failure.
Web-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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Antalya, Turkey
- Akdeniz University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Undergoing treatment at the Cardiology Clinic of Akdeniz University Hospital with a diagnosis of heart failure.
- Class I, II, III according to NYHA classification
- Has internet access and can use a computer / tablet or smartphone
- Agree to participate in the research
Exclusion Criteria:
- Functional class IV according to NYHA classification
- Diagnosed with psychiatric illness
- Malignancy diagnosed
- Visually and hearing impaired
- Diagnosed with chronic obstructive pulmonary disease
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: web-based training and telephone monitoring
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.
|
web-based training and telephone monitoring and short message
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Has an effect on reducing symptom burden
Time Frame: 3 months
|
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.
|
3 months
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Has an effect on improving quality of life
Time Frame: 3 months
|
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.
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3 months
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Reducing heart failure patient rehospitalizations
Time Frame: 3 months
|
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.
|
3 months
|
Positive effects on waist circumference
Time Frame: 3 months
|
Waist circumference assessment form: The form was prepared by the researcher to record the waist circumference of the patients as "centimeters" unit.
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3 months
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Positive effects on weight
Time Frame: 3 months
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Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.
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3 months
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Positive effects on blood pressure
Time Frame: 3 months
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Blood pressure assessment form: The form was prepared by the researcher to record the blood pressure of the patients as "mmHg" units
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3 months
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Positive effects on creatinine
Time Frame: 3 months
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Creatinine assessment form: A form was prepared by the researcher to record normal creatinine levels in the blood as "milligram" units.
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3 months
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- 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.
- 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.
- 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. Erratum In: Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):309-310. English, Spanish.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Akdeniz University 07
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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