NCT04210167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Apr 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 24, 2019

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

August 12, 2024

Status Verified

August 1, 2024

Enrollment Period

1.3 years

First QC Date

December 19, 2019

Last Update Submit

August 9, 2024

Conditions

Keywords

heart failureweb-based trainingtelephone monitoringsymptom assessmentquality of life

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • Positive effects on weight

    Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.

    3 months

  • 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

  • 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

Study Arms (1)

web-based training and telephone monitoring

EXPERIMENTAL

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.

Behavioral: web-based training and telephone monitoring

Interventions

web-based training and telephone monitoring and short message

web-based training and telephone monitoring

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Functional class IV according to NYHA classification
  • Diagnosed with psychiatric illness
  • Malignancy diagnosed
  • Visually and hearing impaired
  • Diagnosed with chronic obstructive pulmonary disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Akdeniz University

Antalya, Turkey (Türkiye)

Location

Related Publications (7)

  • 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: 26307539BACKGROUND
  • 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: 27894487BACKGROUND
  • 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: 23787723BACKGROUND
  • 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: 25628261BACKGROUND
  • 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: 28045703BACKGROUND
  • 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: 28461259BACKGROUND
  • 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.

    PMID: 15916924BACKGROUND

Related Links

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Zeynep ÖZER, PhD, RN

    Akdeniz University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: This study is a randomized controlled study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
lecturer

Study Record Dates

First Submitted

December 19, 2019

First Posted

December 24, 2019

Study Start

April 1, 2018

Primary Completion

August 1, 2019

Study Completion

January 1, 2020

Last Updated

August 12, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will share

All collected IPD will share

Shared Documents
STUDY PROTOCOL, SAP, CSR
Time Frame
starting 1 months after publication
Access Criteria
all people access

Locations