Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)

Study Overview
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Brief Summary
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The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure. To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide: Improved self-care Improved quality of life and reduced number of patient-assessed symptoms Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits

Official Title
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Evaluation of a Digital Support and Communication Platform for Heart Failure:

Conditions
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Heart Failure

Intervention / Treatment
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* Device: LifePod


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016. Have completed the consent form or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial. It is assessed that they can handle the intervention themselves or with the help of personal or relatives. Exclusion Criteria: Patient who declines to participate in the trial. Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner. Life expectancy <8 months In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention group<br>Standard heart failure care and a digital heart failure support system | Device: LifePod<br>* The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider<br>|
| Other: Control group<br>Standard heart failure care | Device: LifePod<br>* The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-care behaviour | Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45. | 6 month | 
| Cardiovascular events and deaths | Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion | 12 month | 
| Hospitalization and hospital days | Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion | 12 months | 
| Health care visits | Type and number of health care visits during intervention and up to 12 months after inclusion | 12 months | 
| Patient-reported symptoms | Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points. | 6 months | 
| Quality of life | Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life | 6 months |