Remote Monitoring After Heart Failure
Study Details
Study Description
Brief Summary
Even though follow-up from specialist healthcare after hospitalization for an acute heart failure event is strongly recommended in European guidelines, only approximately one out of five patients in Norway were offered participation at an outpatient program today. Increasing evidence suggest that remote monitoring (e.g. telemonitoring) might be a beneficial alternative that effectively reduce hospital admission rates and improve quality of life in these patients. However, it remains to be established whether remote monitoring is feasible and cost-effective for the majority of patients hospitalized with heart failure in routine clinical practice. This randomized controlled multi-center pilot study aims to test whether a nurse-led remote monitoring program is a useful and feasible method to follow-up patients in clinical practice after hospitalization for an acute heart failure event. The investigators also aim to assess effects on health-related quality of life, self-management, psychological stress, heart failure biomarkers and readmissions. In all, 100 patients were randomized to a nurse-led remote monitoring program or usual care at to secondary care hospitals in Norway. Study endpoints were collected after six months follow-up. Qualitative in-depth interviews will be performed at study-end among participants in the intervention group (N=12) and among study nurses (N=4).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Intervention Remote monitoring program |
Other: Nurse-led remote monitoring program
Symptoms of disease progression, clinical parameters, medication adherence and follow-up needs will be monitored every 14th day using a digital platform during the study period. Telephone monitoring is planned for patients who are not able to comply with the digital platform.
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| Active Comparator: Usual care Current clinical pratice at the participating hospitals |
Other: Usual care treatment
Usual care treatment and follow-up care at the outpatient clinic and in primary care
|
Outcome Measures
Primary Outcome Measures
- Participation rate [At time of randomization]
The proportion of invited patients fulfilling the study entry criteria enrolled into the trial recorded by study nurses
- Feasibility with the intervention [Six months after randomization]
The proportion of patients randomised to the intervention who successfully reported data into the digital platform and the proportion who switched to telephone follow-up
- Patient adherence to the intervention [Six months after randomization]
Adherence to the digital platform measured as the mean number of responses from participants entered into the platform during the study period
- Patient satisfaction with the intervention [Six months after randomization]
Satisfaction with digital platform assessed from through a six-item deNovo self-report questionnaire developed by the study group and thorugh a qualitative in-depth interviews with 10 participants
- Feasibility and satisfaction reported by study nurses [Six months after randomization]
Feasibility and satisfaction with digital platform reported by study nurses in a qualitative in-depth interviews
Secondary Outcome Measures
- Differences in changes in heart failure biomarkers [From baseline until six months follow-up]
Differences between the study groups in changes in pro brain natriuretic peptide (BNP) measured in blood.
- Differences in healthcare utilization [At six months follow-up]
Differences between the study groups in total number of i. outpatient consultations, ii. deaths and iii. hospitalizations for all causes
- Differences in length of hospital stays [At six months follow-up]
Differences between the study groups in length of hospital stays (number of days) for re-hospitalizations during the follow-up period
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age> 18 years Acute hospitalization for an acute heart failure event as described in 2017 Cardiovascular and Stroke Endpoint Definitions for Clinical Trials
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Sign informed consent and expected to participate according to ICH / GCP
Exclusion Criteria:
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Any condition (e.g. psychosis, alcohol abuse, dementia) or situation that may pose a significant risk to the participant, confuse the results or make participation unethical
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Lack of Norwegian and English knowledge
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Short life expectancy (<6 months)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Vestfold Hospital Trust | Tønsberg | Vestfold And Telemark County | Norway | 3103 |
| 2 | Vestre Viken Trust Drammen hospital | Drammen | Viken County | Norway | 3004 |
Sponsors and Collaborators
- Vestre Viken Hospital Trust
- The Hospital of Vestfold
- University of Oslo
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 464460