Heart Failure
Conditions
Keywords
Telemedicine, Effectiveness, Cost-effectiveness
Brief summary
There are two main aims in this study. The first objective is to evaluate whether a particular telehealth solution, in addition to standard treatment and care, lead to a significant decrease in the mortality and an increase in health related quality of life for patients suffering from Heart Failure that may benefit from telehealth compared with only standard treatment and care. The second objective is to examine the additional costs of the telehealth solution and assess whether this solution is a cost-effective way to care for patients with Heart Failure across patients and municipality districts. It is hypothesized that telehealth care will increase patients quality adjusted life years compared to usual practice, since no difference in mortality and a higher health related quality of life is expected. Furthermore, it is hoped that there will be a 30% reduction in the number of admissions and readmissions to hospitals and a 30% reduction in the number of outpatient visits resulting in fewer costs for hospitals. However, it is uncertain as to whether these savings are offset by other costs such as more visits to general practitioners, community care or the implementation costs.
Interventions
DEVICETelemedicine
Sponsors
Aalborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* All heart failure patients that may benefit from telehealthcare. * Participants are qualified for inclusion if they have been diagnosed with HF according to national guidelines and are NYHA classified 2,3, and 4. * Patients must have a permanent residence and be motivated for using telehealthcare. \*Patients must have a landline or mobile phone and be able to speak Danish or they must live with a relative speaking Danish. Such that the relative must be able to help the patient in translating the information in the use of telehealthcare.
Exclusion criteria
* Patients without landline phone / mobile phone or GSM (Global System for Mobile Communications) coverage. * Patients not able to understand Danish adequately to complete the questionnaires in the study or patients having a cognitive impairment. * Comorbidity is not an exclusion criterion.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mental health related quality of life (SF-36 questionnaire mental scores) | 12 month follow-up | Changes in mental health-related quality of life (SF-36 questionnaire mental score) at baseline to follow-up. |
| Incremental cost-effectiveness ratio (ICER) | 12 month follow-up | The main outcome for cost is incremental cost-effectiveness ratio (ICER). ICER is measured as the total cost per quality adjusted life years (QALY) increased from baseline to follow-up. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in daily functioning (KCCQ questionnaire score) | 12 month follow-up | Changes in daily functioning measured by KCCQ questionnaire score. |
| Physical health related quality of life (SF-36 questionnaire Physical scores) | 12 month follow-up | Changes in physical health-related quality of life (SF-36 questionnaire physical score) at baseline to follow-up. |
Countries
Denmark
Outcome results
None listed