The Effect of Web-based Training and Telephone Monitoring on Patients With Heart Failure
Primary Purpose
Heart Failure, Patient, Quality of Life
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
web-based training and telephone monitoring
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring heart failure, web-based training, telephone monitoring, symptom assessment, quality of life
Eligibility Criteria
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
Sites / Locations
- Akdeniz University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
web-based training and telephone monitoring
Arm 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.
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
Positive effects on weight
Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.
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
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04210167
First Posted
December 19, 2019
Last Updated
December 21, 2019
Sponsor
Akdeniz University
1. Study Identification
Unique Protocol Identification Number
NCT04210167
Brief Title
The Effect of Web-based Training and Telephone Monitoring on Patients With Heart Failure
Official Title
The Effect of Web Based Training and Telephone Follow-up on Symptom Management and Quality of Life in Patients With Heart Failure
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 1, 2018 (Actual)
Primary Completion Date
August 1, 2019 (Actual)
Study Completion Date
January 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Akdeniz University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Patient, Quality of Life, Symptoms
Keywords
heart failure, web-based training, telephone monitoring, symptom assessment, quality of life
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
This study is a randomized controlled study
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
web-based training and telephone monitoring
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
web-based training and telephone monitoring
Intervention Description
web-based training and telephone monitoring and short message
Primary Outcome Measure Information:
Title
Has an effect on reducing symptom burden
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.
Time Frame
3 months
Title
Has an effect on improving quality of life
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.
Time Frame
3 months
Title
Reducing heart failure patient rehospitalizations
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.
Time Frame
3 months
Title
Positive effects on waist circumference
Description
Waist circumference assessment form: The form was prepared by the researcher to record the waist circumference of the patients as "centimeters" unit.
Time Frame
3 months
Title
Positive effects on weight
Description
Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.
Time Frame
3 months
Title
Positive effects on blood pressure
Description
Blood pressure assessment form: The form was prepared by the researcher to record the blood pressure of the patients as "mmHg" units
Time Frame
3 months
Title
Positive effects on creatinine
Description
Creatinine assessment form: A form was prepared by the researcher to record normal creatinine levels in the blood as "milligram" units.
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeynep ÖZER, PhD, RN
Organizational Affiliation
Akdeniz University
Official's Role
Study Director
Facility Information:
Facility Name
Akdeniz University
City
Antalya
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
All collected IPD will share
IPD Sharing Time Frame
starting 1 months after publication
IPD Sharing Access Criteria
all people access
Citations:
PubMed Identifier
26307539
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.
Results Reference
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PubMed Identifier
27894487
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. Erratum In: Rev Esp Cardiol (Engl Ed). 2017 Apr;70(4):309-310. English, Spanish.
Results Reference
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PubMed Identifier
23787723
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.
Results Reference
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PubMed Identifier
25628261
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.
Results Reference
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PubMed Identifier
28045703
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.
Results Reference
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PubMed Identifier
28461259
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.
Results Reference
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PubMed Identifier
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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.
Results Reference
background
Links:
URL
http://www.heart.org/HEARTORG/Conditions/HeartFailure/WarningSignsforHeartFailure/W
Description
American Heart Association, Warning Signs of Heart Failure
Learn more about this trial
The Effect of Web-based Training and Telephone Monitoring on Patients With Heart Failure
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