Heart FailureNCT04210167
Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial
A study testing web-based training and telephone monitoring in people with Heart Failure and Patient, run by Akdeniz University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Heart Failure, Patient, Quality of Life
- What is being tested?
- web-based training and telephone monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Apr 2018to 1 Jan 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Functional class IV according to NYHA classification
- Diagnosed with psychiatric illness
- Malignancy diagnosed
- Visually and hearing impaired
- Diagnosed with chronic obstructive pulmonary disease
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Heart Failure, Patient, Quality of Life, Symptoms
- Being tested
- web-based training and telephone monitoring
- Keywords
- heart failure, web-based training, telephone monitoring, symptom assessment, quality of life
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
web-based training and telephone monitoringBehavioural
web-based training and telephone monitoring and short message
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: web-based training and telephone monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months
Positive effects on weight
Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.
Measured: 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
Measured: 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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start1 Apr 2018
- Primary completion1 Aug 2019
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by Akdeniz UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This study is a randomized controlled study
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akdeniz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emine İLASLAN, Akdeniz University
- Investigators
- Zeynep ÖZER, PhD, RN, Study director, Akdeniz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210167
- Sponsor's protocol ID
- Akdeniz University 07
- Status last verified
- Aug 2024
- First submitted
- 19 Dec 2019
- Last updated
- 12 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD will share
Publications
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.
PubMed 26307539Ponikowski 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.
PubMed 27894487Seferovic 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.
PubMed 23787723Wakefield 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.
PubMed 25628261Wakefield 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.
PubMed 28045703Yancy 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.
PubMed 28461259Zambroski 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.
PubMed 15916924
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Web-based Training and Telephone Follow-up of Patients With Heart Failure: Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04210167
- Acronym / sponsor ID
- Akdeniz University 07
- Conditions
- Heart Failure, Patient, Quality of Life, Symptoms
- Keywords
- heart failure, web-based training, telephone monitoring, symptom assessment, quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Akdeniz UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Aug 2019 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This study is a randomized controlled study
| Arm | Type | Receives |
|---|---|---|
| web-based training and telephone monitoring | Experimental | Behavioral: web-based training and telephone monitoringThe 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- Functional class IV according to NYHA classification
- Diagnosed with psychiatric illness
- Malignancy diagnosed
- Visually and hearing impaired
- Diagnosed with chronic obstructive pulmonary disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| web-based training and telephone monitoringweb-based training and telephone monitoring and short message | Behavioural | web-based training and telephone monitoring |
Primary outcome
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.
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.
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.
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.
Positive effects on weight
Time frame: 3 months
Weight assessment form: The form was prepared by the researcher to record the patients' weights in "kilogram" units.
Positive effects on blood pressure
Time frame: 3 months
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
Time frame: 3 months
Creatinine assessment form: A form was prepared by the researcher to record normal creatinine levels in the blood as "milligram" units.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2024.
- Background: PubMed 26307539Piamjariyakul 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.
- Background: PubMed 27894487Ponikowski 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.
- Background: PubMed 23787723Seferovic 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.
- Background: PubMed 25628261Wakefield 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.
- Background: PubMed 28045703Wakefield 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.
- Background: PubMed 28461259Yancy 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.
- Background: PubMed 15916924Zambroski 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.
- American Heart Association, Warning Signs of Heart FailureLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All collected IPD will share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Zeynep ÖZER, PhD, RN study director
Akdeniz University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing web-based training and telephone monitoring in people with Heart Failure and Patient, run by Akdeniz University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Has an effect on reducing symptom burden (time frame: 3 months). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210167, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.