Personal Decision Support System for Heart Failure Management

NCT05651698 | Completed DMC

• 1 other identifier: B670201733342
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 2

Brief Summary

Despite the availability of evidence-based guidelines for disease management in patients with congestive heart failure (CHF), the uptake of these guidelines in clinical practice is sub-optimal and adherence rates are disappointing. Within the HeartMan project, a personal e-health system was developed to help CHF patients manage their disease, with the ultimate goal to improve health-related quality of life (HRQoL). The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone. A proof of concept trial with a 1:2 (control:intervention) randomization protocol was designed. The sample size calculation was based on primary outcome data from the previous CHIRON project, showing that 90 patients are needed to show at least -5.8 (± 6 to 8 s.d.) beats/min difference in average daily awake heart rate difference - as a fundamental parameter correlating with patient-reported HRQoL - with 90% power between the two groups. Data collection will include an estimation of exercise capacity based on a six-minute walking test, and questionnaire assessments using standardized instruments. The trial will be initiated in two countries. In order to account for possible drop-outs, 60 patients will be enrolled in Italy and 60 in Belgium (20 control and 40 intervention patients in each country). Target patients are stable ambulatory CHF patients (NYHA class 2-3; reduced left ventricular ejection fraction ≤40%). Eligible patients will be recruited by their treating physician from collaborating medical centers in both countries; they will be enrolled in the trial after giving informed consent for participation. After baseline assessment, patients will be randomized into either the intervention (duration of 6 months) or control (usual care) condition. Data collection will be repeated at the end of the trial.

Conditions

Heart Failure，Congestive

Keywords

Heart Failure; Heart Failure Patients' Disease Management; Health-related Quality of Life; mHealth

Outcome Measures

Primary Outcomes (2)

• Self-reported improvement in self-care and health-related quality of life

  Measured by the Self-care of Heart Failure Index and Minnesota Living with Heart Failure Questionnaire

  Month 7 (end trial)

• Self-reported improvement in self-care and health-related quality of life

  Measured by the Self-care of Heart Failure Index and Minnesota Living with Heart Failure Questionnaire

  Month 0 (start trial)

Secondary Outcomes (16)

• Effect of HeartMan on adherence to dietary recommendations

  Month 0 (start trial)

• Effect of HeartMan on adherence to dietary recommendations

  Month 7 (end trial)

• Effect of HeartMan on activity behavior

  Month 0 (start trial)

• Effect of HeartMan on activity behavior

  Month 7 (end trial)

• Effect of HeartMan on medication adherence

  Month 0 (start trial)

Study Arms (2)

HeartMan Intervention group

EXPERIMENTAL

80 patients are in the intervention group (40 in Belgium and 40 in Italy).

Device: HeartMan Intervention group

Control group

NO INTERVENTION

40 patients are in the intervention group (20 in Belgium and 20 in Italy). Standard care consists of optimal medical treatment according to the international guidelines. In addition, written and oral education on heart failure disease and its management is provided by the heart failure nurse at the moment a patient has been diagnosed with heart failure or whenever he is rehospitalized for heart failure if necessary. Further support after discharge is possible by giving the patient the opportunity to call with the heart failure nurse in case he has questions about his treatment or health condition. Regular visits with the treating physician are scheduled several times per year.

Interventions

HeartMan Intervention group DEVICE

The system uses wrist-band sensors to monitor patients' physical activity and physiological parameters. These data are connected to a decision support system, providing medical advice to patients concerning physical exercise, nutrition, medication intake, clinical measurements, environment management, and mental support. The decision support system is based on predictive models, clinical care guidelines and expert knowledge. The advice will be personalized according to each individual patient's medical and psychological profile, and will be presented to the patient through the user interface of a mobile application on a smartphone.

HeartMan Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing and able to make use of a smartphone and to give informed consent for participation to the study
• Ischemic or non- ischemic heart failure disease
• Functional New York Heart Association (NYHA) class 2-3
• Reduced left ventricular ejection fraction ≤40%
• Ambulatory HF patients in stable condition: at least one hospitalization due to their HF once, but no hospitalization during the month before start of the trial or no planned surgery
• Good cognitive function, if cognitive impairment is suspected the patient will be evaluated by using the Mini Mental State Examination (MMSE)
• Sufficient knowledge of the native language (Dutch in Belgium, Italian in Italy)

You may not qualify if:

• Heart failure patients who fulfill the above mentioned criteria, but suffer from a concomitant end - stage chronic kidney disease necessitating haemodialysis
• Heart failure patients who fulfill the above mentioned criteria, but are already participating in a disease management program, influencing the HeartMan intervention

Sponsors & Collaborators

• University Ghent: lead
• University of Roma La Sapienza: collaborator

Study Sites (2)

University Ghent

Ghent, 9000, Belgium

Location

Sapienza University of Rome

Rome, 00185, Italy

Location

Related Publications (16)

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  PMID: 17699180 BACKGROUND

• Cook C, Cole G, Asaria P, Jabbour R, Francis DP. The annual global economic burden of heart failure. Int J Cardiol. 2014 Feb 15;171(3):368-76. doi: 10.1016/j.ijcard.2013.12.028. Epub 2013 Dec 22.

  PMID: 24398230 BACKGROUND

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  PMID: 23989710 BACKGROUND

• McDonagh TA, Blue L, Clark AL, Dahlstrom U, Ekman I, Lainscak M, McDonald K, Ryder M, Stromberg A, Jaarsma T; European Society of Cardiology Heart Failure Association Committee on Patient Care. European Society of Cardiology Heart Failure Association Standards for delivering heart failure care. Eur J Heart Fail. 2011 Mar;13(3):235-41. doi: 10.1093/eurjhf/hfq221. Epub 2010 Dec 15.

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• Piepoli MF, Conraads V, Corra U, Dickstein K, Francis DP, Jaarsma T, McMurray J, Pieske B, Piotrowicz E, Schmid JP, Anker SD, Solal AC, Filippatos GS, Hoes AW, Gielen S, Giannuzzi P, Ponikowski PP. Exercise training in heart failure: from theory to practice. A consensus document of the Heart Failure Association and the European Association for Cardiovascular Prevention and Rehabilitation. Eur J Heart Fail. 2011 Apr;13(4):347-57. doi: 10.1093/eurjhf/hfr017.

  PMID: 21436360 BACKGROUND

• Bjarnason-Wehrens B, McGee H, Zwisler AD, Piepoli MF, Benzer W, Schmid JP, Dendale P, Pogosova NG, Zdrenghea D, Niebauer J, Mendes M; Cardiac Rehabilitation Section European Association of Cardiovascular Prevention and Rehabilitation. Cardiac rehabilitation in Europe: results from the European Cardiac Rehabilitation Inventory Survey. Eur J Cardiovasc Prev Rehabil. 2010 Aug;17(4):410-8. doi: 10.1097/HJR.0b013e328334f42d.

  PMID: 20300001 BACKGROUND

• Black JT, Romano PS, Sadeghi B, Auerbach AD, Ganiats TG, Greenfield S, Kaplan SH, Ong MK; BEAT-HF Research Group. A remote monitoring and telephone nurse coaching intervention to reduce readmissions among patients with heart failure: study protocol for the Better Effectiveness After Transition - Heart Failure (BEAT-HF) randomized controlled trial. Trials. 2014 Apr 13;15:124. doi: 10.1186/1745-6215-15-124.

  PMID: 24725308 BACKGROUND

• Inglis SC, Clark RA, Dierckx R, Prieto-Merino D, Cleland JG. Structured telephone support or non-invasive telemonitoring for patients with heart failure. Cochrane Database Syst Rev. 2015 Oct 31;2015(10):CD007228. doi: 10.1002/14651858.CD007228.pub3.

  PMID: 26517969 BACKGROUND

• Chaudhry SI, Mattera JA, Curtis JP, Spertus JA, Herrin J, Lin Z, Phillips CO, Hodshon BV, Cooper LS, Krumholz HM. Telemonitoring in patients with heart failure. N Engl J Med. 2010 Dec 9;363(24):2301-9. doi: 10.1056/NEJMoa1010029. Epub 2010 Nov 16.

  PMID: 21080835 BACKGROUND

• Koehler F, Winkler S, Schieber M, Sechtem U, Stangl K, Bohm M, Boll H, Baumann G, Honold M, Koehler K, Gelbrich G, Kirwan BA, Anker SD; Telemedical Interventional Monitoring in Heart Failure Investigators. Impact of remote telemedical management on mortality and hospitalizations in ambulatory patients with chronic heart failure: the telemedical interventional monitoring in heart failure study. Circulation. 2011 May 3;123(17):1873-80. doi: 10.1161/CIRCULATIONAHA.111.018473. Epub 2011 Mar 28.

  PMID: 21444883 BACKGROUND

• Ong MK, Romano PS, Edgington S, Aronow HU, Auerbach AD, Black JT, De Marco T, Escarce JJ, Evangelista LS, Hanna B, Ganiats TG, Greenberg BH, Greenfield S, Kaplan SH, Kimchi A, Liu H, Lombardo D, Mangione CM, Sadeghi B, Sadeghi B, Sarrafzadeh M, Tong K, Fonarow GC; Better Effectiveness After Transition-Heart Failure (BEAT-HF) Research Group. Effectiveness of Remote Patient Monitoring After Discharge of Hospitalized Patients With Heart Failure: The Better Effectiveness After Transition -- Heart Failure (BEAT-HF) Randomized Clinical Trial. JAMA Intern Med. 2016 Mar;176(3):310-8. doi: 10.1001/jamainternmed.2015.7712.

  PMID: 26857383 BACKGROUND

• Zannad F, Garcia AA, Anker SD, Armstrong PW, Calvo G, Cleland JG, Cohn JN, Dickstein K, Domanski MJ, Ekman I, Filippatos GS, Gheorghiade M, Hernandez AF, Jaarsma T, Koglin J, Konstam M, Kupfer S, Maggioni AP, Mebazaa A, Metra M, Nowack C, Pieske B, Pina IL, Pocock SJ, Ponikowski P, Rosano G, Ruilope LM, Ruschitzka F, Severin T, Solomon S, Stein K, Stockbridge NL, Stough WG, Swedberg K, Tavazzi L, Voors AA, Wasserman SM, Woehrle H, Zalewski A, McMurray JJ. Clinical outcome endpoints in heart failure trials: a European Society of Cardiology Heart Failure Association consensus document. Eur J Heart Fail. 2013 Oct;15(10):1082-94. doi: 10.1093/eurjhf/hft095. Epub 2013 Jun 19.

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• Anker SD, Agewall S, Borggrefe M, Calvert M, Jaime Caro J, Cowie MR, Ford I, Paty JA, Riley JP, Swedberg K, Tavazzi L, Wiklund I, Kirchhof P. The importance of patient-reported outcomes: a call for their comprehensive integration in cardiovascular clinical trials. Eur Heart J. 2014 Aug 7;35(30):2001-9. doi: 10.1093/eurheartj/ehu205. Epub 2014 Jun 5.

  PMID: 24904027 BACKGROUND

• Chamberlain AM, Manemann SM, Dunlay SM, Spertus JA, Moser DK, Berardi C, Kane RL, Weston SA, Redfield MM, Roger VL. Self-rated health predicts healthcare utilization in heart failure. J Am Heart Assoc. 2014 May 28;3(3):e000931. doi: 10.1161/JAHA.114.000931.

  PMID: 24870937 BACKGROUND

• O'Connor CM, Whellan DJ, Wojdyla D, Leifer E, Clare RM, Ellis SJ, Fine LJ, Fleg JL, Zannad F, Keteyian SJ, Kitzman DW, Kraus WE, Rendall D, Pina IL, Cooper LS, Fiuzat M, Lee KL. Factors related to morbidity and mortality in patients with chronic heart failure with systolic dysfunction: the HF-ACTION predictive risk score model. Circ Heart Fail. 2012 Jan;5(1):63-71. doi: 10.1161/CIRCHEARTFAILURE.111.963462. Epub 2011 Nov 23.

  PMID: 22114101 BACKGROUND

• Ponikowski P, Voors AA, Anker SD, Bueno H, Cleland JG, Coats AJ, Falk V, Gonzalez-Juanatey JR, Harjola VP, Jankowska EA, Jessup M, Linde C, Nihoyannopoulos P, Parissis JT, Pieske B, Riley JP, Rosano GM, Ruilope LM, Ruschitzka F, Rutten FH, van der Meer P; Authors/Task Force Members; Document Reviewers. 2016 ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure: The Task Force for the diagnosis and treatment of acute and chronic heart failure of the European Society of Cardiology (ESC). Developed with the special contribution of the Heart Failure Association (HFA) of the ESC. Eur J Heart Fail. 2016 Aug;18(8):891-975. doi: 10.1002/ejhf.592. Epub 2016 May 20. No abstract available.

  PMID: 27207191 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Paolo Emilio Puddu, Prof.

  University of Roma La Sapienza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2021
• First Posted: December 15, 2022
• Study Start: January 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: December 15, 2022

Record last verified: 2022-12

Locations

BE (1); IT (1)