Implementation and Cost-evaluation of a Smartphone-based Telemonitoring and Digital Support in Patients With HF

NCT05487365 | Unknown DMC

• 1 other identifier: BEDICARE-HF
• Study Type: interventional
• Target: 330
• Locations: 1 country
• Sites: 1

Brief Summary

The BEDICARE-HF study aims to go further in the research on digital support. The objectives of this study are to demonstrate the feasibility, acceptability, adoption, sustainability and safety of a of a smartphone-based digital support system in the Belgian healthcare system. It also aims to effectiveness, evaluate the cost of implementation of the system and demonstrate the cost-effectiveness. The study is multi-center, involving the principal investigator, Dr. Pouleur at Cliniques University Clinics Brussels, and co-investigators from 10 hospitals across Belgium. These physicians will enroll 15 patients on Comunicare's online platform. The patients will then have access to the Comunicare application for 6 months, where they will be asked to answer questionnaires and take their vital parameters. They will also have access to documentation on their pathology and will be able to perform videoconferences with their doctor/nurse via the platform. Eligible patients are patients discharged from hospital for cardiac decompensation. At the time of inclusion, patients must be in NYHA (New-York Heart association) class II, III, or IV, with an LVEF (ejection fraction ejection fraction) of ≤50%. The BEDICARE-HF project is based on the standard of care that an HF (heart fealure) patient would receive without being part of any study. No other invasive interventions are additionally planned by the project. The patient data collected by the recruiting physician is secured by Comunicare. These fully anonymized data will be sent to Jessa at the end of the study for statistical and economic economic analysis of the results. The BEDICARE-HF study will therefore investigate the implementation of a digital support intervention for HF supported by smartphone in a European legislative framework. This study will allow further in the evaluation of digital support for HF and to evaluate a low-cost smartphone solution. The results of this study will demonstrate whether and how a smartphone-based digital support system improves self-care capabilities, clinical management, and health outcomes of patients with HF. They will provide important information on the implementation of a implementation of a digital support system in a specific healthcare setting.

Conditions

Heart Failure; Heart Failure NYHA Class II; Heart Failure NYHA Class III; Heart Failure NYHA Class IV

Keywords

heart failure; digital support; smartphone; digital health; implementation; remote patient management; telemonitoring

Outcome Measures

Primary Outcomes (2)

• Efficiency measures

  Demonstrate that this solution makes good use of time and energy in a way that does not waste it. This will be measured via daily time spent by case nurses using the platform, compared to time spent without the solution.

  Through study completion, an average of 6 months

• Cost-effectiveness

  To evaluate the implementation cost of the system, and to demonstrate cost-effectiveness. It will be calculated using healthcare cost data and work productivity and impairment (WPAI) questionnaire to calculate incremental cost-effectiveness ratio (ICER).

  Through study completion, an average of 6 months

Secondary Outcomes (6)

• Patient acceptability

  at 3 and 6 months

• Adoption and sustainability

  Through study completion, an average of 6 months

• Quality of patient life

  At the recruitment, after 3 ans 6 months

• Patient literacy

  At the recruitment, after 3 ans 6 months

• Patient self-care

  At the recruitment, after 3 ans 6 months

Study Arms (2)

Patients with application

EXPERIMENTAL

Eligible patients are consecutive patients that are hospitalised for HF decompensation. The patients will be included in the programme during their hospitalisation or up to one month after hospitalisation. All eligible patients will be offered to participate. At the time of inclusion, patients must be in NYHA class II, III, or IV with a left ventricular ejection fraction (LVEF) of ≤50%. A total of 165 patients with app will be included over 6 month. Patients are not randomised and will all be participating in the smartphone digital support intervention. Patients are not randomised and will all be participating in the smartphone digital support intervention. So the app will be made available to 165 patients for home monitoring and another group of 165 patients without an application will be asked to answer quality of life questionnaires. Patients who agree to use the application can continue to use it after the study, if they wish.

Device: Comunicare Solutions Smartphone Application

Patients without application

ACTIVE COMPARATOR

Patients refusing participation will also be asked to complete a quality of life (QOL)-questionnaire at 6 months and 12 months which will be answered online. A total of 165 patients (who do not want to participate) will be asked to answer this questionnaire. So the app will be made available to 165 patients for home monitoring and another group of 165 patients without an application will be asked to answer quality of life questionnaires. Patients who agree to use the application can continue to use it after the study, if they wish.

Other: Completing a quality of life (QOL)-questionnaire

Interventions

Comunicare Solutions Smartphone Application DEVICE

The Comunicare patient support solution is specifically designed for digital support of HF. It consists of an application for patients and a dashboard for the caregivers. The application is a class 1 certified medical device. It includes different modules for patient education, medication adherence, symptoms tracking, electronic patient-reported outcome (ePRO), appointments, and video consultation. Caregiver dashboard application: this web-based application enables caregivers to administrate the care flow and review all patient-reported data and the alarm generated by the system. Security and Privacy: the application complies with strict security and privacy-related regulations. All data storages are encrypted on the patients' smartphone and a server located in an ISO-certified data center located in Belgium, and all information exchanges are highly secured. A GDPR-compliant privacy notice defines how patient personal data is processed and how data protection principles are applied.

Patients with application

Completing a quality of life (QOL)-questionnaire OTHER

Patients refusing to use Comunicare app will also be asked to complete a quality of life (QOL)-questionnaire at 0, 6 and 12 months which will be answered online.

Patients without application

Eligibility Criteria

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

You may qualify if:

• Diagnosed with HF - NYHA class II-IV
• LVEF ≤50%.
• Owning a smartphone and able to use an application
• Written informed consent obtained

You may not qualify if:

• Acute coronary syndrome
• High urgent listed for heart transplantation
• Known alcohol or drug abuse
• Terminal renal insufficiency with haemodialysis or peritoneal dialysis
• Impairment or unwillingness to use the digital support equipment (e.g. dementia, impaired self-determination, lacking ability to communicate)
• Existence of any non-cardiac disease reducing life expectancy to less than 1 year
• Age \<18 years
• Participation in other treatment studies or remote patient management programmes

Sponsors & Collaborators

• Comunicare Solutions SA: lead
• Jessa Hospital: collaborator
• Hasselt University, Faculty of Medicine and Life Sciences, Hasselt, Belgium: collaborator
• KU Leuven: collaborator
• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: collaborator
• Centre Hospitalier Régional de la Citadelle: collaborator

Study Sites (1)

Attipoe

Liège, 4000, Belgium

RECRUITING

Related Publications (10)

• 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; ESC Scientific Document Group. 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 Heart J. 2016 Jul 14;37(27):2129-2200. doi: 10.1093/eurheartj/ehw128. Epub 2016 May 20. No abstract available.

  PMID: 27206819 BACKGROUND

• Abraham WT, Stevenson LW, Bourge RC, Lindenfeld JA, Bauman JG, Adamson PB; CHAMPION Trial Study Group. Sustained efficacy of pulmonary artery pressure to guide adjustment of chronic heart failure therapy: complete follow-up results from the CHAMPION randomised trial. Lancet. 2016 Jan 30;387(10017):453-61. doi: 10.1016/S0140-6736(15)00723-0. Epub 2015 Nov 9.

  PMID: 26560249 BACKGROUND

• Hindricks G, Taborsky M, Glikson M, Heinrich U, Schumacher B, Katz A, Brachmann J, Lewalter T, Goette A, Block M, Kautzner J, Sack S, Husser D, Piorkowski C, Sogaard P; IN-TIME study group*. Implant-based multiparameter telemonitoring of patients with heart failure (IN-TIME): a randomised controlled trial. Lancet. 2014 Aug 16;384(9943):583-590. doi: 10.1016/S0140-6736(14)61176-4.

  PMID: 25131977 BACKGROUND

• Stehlik J, Schmalfuss C, Bozkurt B, Nativi-Nicolau J, Wohlfahrt P, Wegerich S, Rose K, Ray R, Schofield R, Deswal A, Sekaric J, Anand S, Richards D, Hanson H, Pipke M, Pham M. Continuous Wearable Monitoring Analytics Predict Heart Failure Hospitalization: The LINK-HF Multicenter Study. Circ Heart Fail. 2020 Mar;13(3):e006513. doi: 10.1161/CIRCHEARTFAILURE.119.006513. Epub 2020 Feb 25.

  PMID: 32093506 BACKGROUND

• Koehler F, Koehler K, Deckwart O, Prescher S, Wegscheider K, Kirwan BA, Winkler S, Vettorazzi E, Bruch L, Oeff M, Zugck C, Doerr G, Naegele H, Stork S, Butter C, Sechtem U, Angermann C, Gola G, Prondzinsky R, Edelmann F, Spethmann S, Schellong SM, Schulze PC, Bauersachs J, Wellge B, Schoebel C, Tajsic M, Dreger H, Anker SD, Stangl K. Efficacy of telemedical interventional management in patients with heart failure (TIM-HF2): a randomised, controlled, parallel-group, unmasked trial. Lancet. 2018 Sep 22;392(10152):1047-1057. doi: 10.1016/S0140-6736(18)31880-4. Epub 2018 Aug 25.

  PMID: 30153985 BACKGROUND

• Keutzer L, Simonsson US. Medical Device Apps: An Introduction to Regulatory Affairs for Developers. JMIR Mhealth Uhealth. 2020 Jun 26;8(6):e17567. doi: 10.2196/17567.

  PMID: 32589154 BACKGROUND

• Urbich M, Globe G, Pantiri K, Heisen M, Bennison C, Wirtz HS, Di Tanna GL. A Systematic Review of Medical Costs Associated with Heart Failure in the USA (2014-2020). Pharmacoeconomics. 2020 Nov;38(11):1219-1236. doi: 10.1007/s40273-020-00952-0.

  PMID: 32812149 BACKGROUND

• Lesyuk W, Kriza C, Kolominsky-Rabas P. Cost-of-illness studies in heart failure: a systematic review 2004-2016. BMC Cardiovasc Disord. 2018 May 2;18(1):74. doi: 10.1186/s12872-018-0815-3.

  PMID: 29716540 BACKGROUND

• Ware P, Ross HJ, Cafazzo JA, Laporte A, Seto E. Implementation and Evaluation of a Smartphone-Based Telemonitoring Program for Patients With Heart Failure: Mixed-Methods Study Protocol. JMIR Res Protoc. 2018 May 3;7(5):e121. doi: 10.2196/resprot.9911.

  PMID: 29724704 BACKGROUND

• Ware P, Ross HJ, Cafazzo JA, Boodoo C, Munnery M, Seto E. Outcomes of a Heart Failure Telemonitoring Program Implemented as the Standard of Care in an Outpatient Heart Function Clinic: Pretest-Posttest Pragmatic Study. J Med Internet Res. 2020 Feb 8;22(2):e16538. doi: 10.2196/16538.

  PMID: 32027309 BACKGROUND

Related Links

• Comunicare - Care companion. Comunicare connects the patient with his/her care givers. (Website of the device under study)

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Alfred Attipoe

CONTACT

+32485530169; a.attipoe@comunicare.be

Study Design

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

Model Details: Eligible patients are consecutive patients that are hospitalised for HF decompensation. All eligible patients will be offered to participate. At the time of inclusion, patients must be in NYHA class II to IV with a LVEF of ≤50%. A total of 330 patients will be included over 6 month. 11 hospitals in Belgium with an HF clinic employing at least one certified HF nurse will be participating in patient recruitment. Patients are not randomised and will all be participating in the smartphone digital support intervention. 165 patients will be included to use Comunicare app. Patients refusing use Comunicare app will be asked to complete a quality of life (QOL)-questionnaire at 0, 6, and 12 months. A total of 165 patients (who do not want to use the app) will be asked to answer this questionnaire. So the app will be made available to 165 patients for home monitoring and another group of 165 patients without an application will be asked to answer quality of life questionnaires.

Study Record Dates

• First Submitted: July 12, 2022
• First Posted: August 4, 2022
• Study Start: May 21, 2022
• Primary Completion: November 21, 2022
• Study Completion: November 21, 2022
• Last Updated: August 4, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)