Heart Failure
Conditions
Brief summary
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: 1. Improved self-care 2. Improved quality of life and reduced number of patient-assessed symptoms 3. Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits
Interventions
DEVICELifePod
The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider
Sponsors
Lund University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hospitalization and hospital days | 12 months | Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion |
| Self-care behaviour | 6 month | 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. |
| Cardiovascular events and deaths | 12 month | Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion |
| Health care visits | 12 months | Type and number of health care visits during intervention and up to 12 months after inclusion |
| Patient-reported symptoms | 6 months | 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. |
| Quality of life | 6 months | Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life |
Countries
Sweden
Outcome results
None listed