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Personal Decision Support System for Heart Failure Management (HeartMan)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497871
Recruitment Status : Completed
First Posted : April 13, 2018
Last Update Posted : August 7, 2019
Sponsor:
Collaborators:
University Ghent
University of Roma La Sapienza
Information provided by (Responsible Party):
Jozef Stefan Institute

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.

Condition or disease Intervention/treatment Phase
Heart Failure, Congestive Device: HeartMan system Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Proof-of-concept RCT: A Wearable Mobile Device to Improve Disease Management in Patients With Congestive Heart Failure
Actual Study Start Date : January 1, 2018
Actual Primary Completion Date : June 30, 2019
Actual Study Completion Date : June 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Arm Intervention/treatment
Experimental: HeartMan intervention group

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
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.

No Intervention: Standard care (control) group

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.




Primary Outcome Measures :
  1. Change in self-care and health-related quality of life (1) [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    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.

  2. Change in self-care and health-related quality of life (2) [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    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.

  3. Mortality and hospitalization [ Time Frame: This is an ongoing measurement during the 6 months trial period. ]
    Number of patients with (treatment-related) serious adverse events (SAE), based on hospital records and according to good clinical practice (GCP) guidelines ISO 14155.


Secondary Outcome Measures :
  1. Change in adherence to dietary recommendations [ Time Frame: This is an ongoing measurement during the 6 months trial period. ]
    The effect of HeartMan on adherence to dietary recommendations, measured by a self-composed questionnaire. Patients get asked regularly and randomly during the 6 months trial period to fill in the questionnaire via the HeartMan application.

  2. Change in activity behavior [ Time Frame: This is an ongoing measurement during the 6 months trial period. ]
    The effect of HeartMan on activity behavior, measured by the estimated energy expenditure via the accelerometer in the HeartMan wristband.

  3. Change in medication adherence [ Time Frame: This is an ongoing measurement during the 6 months trial period. ]
    The effect of HeartMan on medication adherence, measured by questioning the patients about their medication intake on a weekly basis during the 6 months trial period.

  4. Change in sexual activity (1) [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]

    The effect of HeartMan on sexual activity. Change from baseline in sexual activity on the Sexual Adjustment Scale at 6 months.

    This is a six-item self-report subscale of the Psychosocial Adjustment Scale that assesses illness-related changes in the quality of sexuality and relationship over the past month. Answers are provided using a four-point Likert scale in which a score of 0 is equal to "no disturbance" and a score of 3 is equal to "marked disturbance". The total score ranges from 0-18, whereby the lower the score the less the disturbance and vice versa.


  5. Change in sexual activity (2) [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]

    The effect of HeartMan on sexual activity. Change from baseline in sexual activity on the Needs for Counselling Scale in chronic Heart Failure at 6 months.

    The questions in each domain are answered with a four-point Likert scale in which a score of 1 is equal to "totally not important" and a score of 4 is equal to "very important". An average score of 2.5 or more is considered to be important and counseling is recommended. A total score is not applicable.


  6. Change in illness perception [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    The effect of HeartMan on illness perception. Change from baseline in illness perception on the Brief Illness Perception Questionnaire at 6 months.

  7. Change in exercise tolerance (1) [ Time Frame: This is an ongoing measurement during the 6 months trial period. ]
    The effect of HeartMan on exercise tolerance. Measured by the change in resting heart rate and heart rate during exercise via the accelerometer in the HeartMan wristband.

  8. Change in exercise tolerance (2) [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    The effect of HeartMan on exercise tolerance. Change from baseline in distance obtained at the six-minute walking test at 6 months.

  9. Change in anxiety [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    Effect of psychological interventions in HeartMan using cognitive behavioral therapy and mindfulness exercise. Change from baseline in anxiety on the State Trait Anxiety Inventory at 6 months.

  10. Change in depression [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    Effect of psychological interventions in HeartMan using cognitive behavioral therapy and mindfulness exercises. Change from baseline in depressive feelings on the Beck Depression Inventory II at 6 months.

  11. Change in patient's experience with HeartMan [ Time Frame: Change from baseline to post-interventional measurement, assessed up to 36 weeks. ]
    Evaluation of the patient's experience with HeartMan to assess the expectations towards the system and the patient's experiences. Change from baseline in patient's experience with HeartMan on the unified theory of acceptance and use of technology questionnaire (adapted for the aims of the HeartMan system and to the population of elderly users) at 6 months.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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)

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497871


Locations
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Belgium
OLV Hospital Aalst
Aalst, Belgium, 9300
General Hospital Maria Middelares
Ghent, Belgium, 9000
University Hospital Ghent
Ghent, Belgium, 9000
Italy
Rieti General Hospital
Rieti, Italy, 02100
Sponsors and Collaborators
Jozef Stefan Institute
University Ghent
University of Roma La Sapienza
Investigators
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Principal Investigator: Els Clays, PhD University Ghent
Principal Investigator: Paolo Emilio Puddu, PhD University of Roma La Sapienza
Additional Information:
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jozef Stefan Institute
ClinicalTrials.gov Identifier: NCT03497871    
Other Study ID Numbers: HeartMan
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jozef Stefan Institute:
Heart failure
Self-management
Health-related quality of life
mHealth
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases