Personal Decision Support System for Heart Failure Management

NCT03497871 | Completed DMC

• 1 other identifier: HeartMan
• Study Type: interventional
• Target: 79
• Locations: 2 countries
• Sites: 4

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 dropouts, 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; Self-management; Health-related quality of life; mHealth

Outcome Measures

Primary Outcomes (3)

• Change in self-care and health-related quality of life (1)

  Change from baseline in self-reported improvement in self-care and health-related quality of life on the Self-care of Heart Failure Index at 6 months.

  Change from baseline to post-interventional measurement, assessed up to 36 weeks.

• Change in self-care and health-related quality of life (2)

  Change from baseline in self-reported improvement in self-care and health-related quality of life on the Minnesota Living with Heart Failure Questionnaire at 6 months.

  Change from baseline to post-interventional measurement, assessed up to 36 weeks.

• Mortality and hospitalization

  Number of patients with (treatment-related) serious adverse events (SAE), based on hospital records and according to good clinical practice (GCP) guidelines ISO 14155.

  This is an ongoing measurement during the 6 months trial period.

Secondary Outcomes (11)

• Change in adherence to dietary recommendations

  This is an ongoing measurement during the 6 months trial period.

• Change in activity behavior

  This is an ongoing measurement during the 6 months trial period.

• Change in medication adherence

  This is an ongoing measurement during the 6 months trial period.

• Change in sexual activity (1)

  Change from baseline to post-interventional measurement, assessed up to 36 weeks.

• Change in sexual activity (2)

  Change from baseline to post-interventional measurement, assessed up to 36 weeks.

Study Arms (2)

HeartMan intervention group

EXPERIMENTAL

80 patients are in the intervention group (40 in Belgium and 40 in Italy). They use the HeartMan system in addition to receiving standard care.

Device: HeartMan system

Standard care (control) group

NO INTERVENTION

40 patients are in the no-intervention group (20 in Belgium and 20 in Italy). They receive standard care, which 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 system DEVICE

The HeartMan system uses wristband 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 heart failure patients in stable condition: at least one hospitalization due to their heart failure once, but no hospitalization during the month before start of the trial and 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

• Jozef Stefan Institute: lead
• University Ghent: collaborator
• University of Roma La Sapienza: collaborator

Study Sites (4)

OLV Hospital Aalst

Aalst, 9300, Belgium

Location

General Hospital Maria Middelares

Ghent, 9000, Belgium

Location

University Hospital Ghent

Ghent, 9000, Belgium

Location

Rieti General Hospital

Rieti, 02100, Italy

Location

Related Publications (18)

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• Lustrek M, Bohanec M, Cavero Barca C, Ciancarelli MC, Clays E, Dawodu AA, Derboven J, De Smedt D, Dovgan E, Lampe J, Marino F, Mlakar M, Pioggia G, Puddu PE, Rodriguez JM, Schiariti M, Slapnicar G, Slegers K, Tartarisco G, Valic J, Vodopija A. A Personal Health System for Self-Management of Congestive Heart Failure (HeartMan): Development, Technical Evaluation, and Proof-of-Concept Randomized Controlled Trial. JMIR Med Inform. 2021 Mar 5;9(3):e24501. doi: 10.2196/24501.

  PMID: 33666562 DERIVED

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  PMID: 30261836 DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Els Clays, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Paolo Emilio Puddu, PhD

  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: March 13, 2018
• First Posted: April 13, 2018
• Study Start: January 1, 2018
• Primary Completion: May 31, 2019
• Study Completion: May 31, 2019
• Last Updated: July 11, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1); BE (3)