Heart Failure Clinical Trial
Official title:
The Effect of Web Based Training and Telephone Follow-up on Symptom Management and Quality of Life in Patients With Heart Failure
Verified date | December 2019 |
Source | Akdeniz University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Enrolling by invitation |
Enrollment | 70 |
Est. completion date | January 1, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Akdeniz University | Antalya |
Lead Sponsor | Collaborator |
---|---|
Akdeniz University |
Turkey,
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. — View Citation
Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JGF, Coats AJS, Falk V, González-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. English, Spanish. Erratum in: Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):309-310. — View 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, Wikström 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Has an effect on reducing symptom burden | 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 | |
Primary | Has an effect on improving quality of life | 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. | 3 months | |
Primary | Reducing heart failure patient rehospitalizations | 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 | |
Primary | Positive effects on waist circumference | Waist circumference assessment form: The form was prepared by the researcher to record the waist circumference of the patients as "centimeters" unit. | 3 months | |
Primary | Positive effects on weight | Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units. | 3 months | |
Primary | Positive effects on blood pressure | Blood pressure assessment form: The form was prepared by the researcher to record the blood pressure of the patients as "mmHg" units | 3 months | |
Primary | Positive effects on creatinine | Creatinine assessment form: A form was prepared by the researcher to record normal creatinine levels in the blood as "milligram" units. | 3 months |
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