Telemedicine in Heart Failure; Treatment, Prognosis and Patient Experience

NCT06237998 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 300

Last updated 2024-02-06

No results posted yet for this study

Summary

Heart failure is a common and serious disease responsible for significant healthcare costs and the need of hospitalizastions. The course of the disease is characterized by periods of progressive deterioration with repeated hospital admissions, especially in the final stages of life. Telemedical self-monitoring is a promising alternative for remote monitoring that can provide individualized treatment, smooth titration of medications and reduce hospital stays. However, the evidence for its benefits is limited, which requires further research.

Our hypotheses are that self-monitoring in heart failure can:

1. Reduce avoidable inpatient care and mortality.
2. Optimize the escalation of medications to optimal medical therapy.
3. Increase self-care and security.
4. Improve the prediction of deterioration in heart failure. Work Plan: We will compare six months of telemedical monitoring with standard care, and integrate telemedical data with electronic health records (EHR) for analysis and development of prognostic models for clinical outcomes (data collection is ongoing). Consecutive heart failure patients (target 300) will receive digital equipment for reporting vital parameters, experiences, and symptoms over six months. Medication adjustments are made remotely, and physical visits as needed. Data on mortality, healthcare needs, and health economics will be collected over two years after the monitoring period. We plan to retrieve a matched control population from the Swedish heart failure registry (SwedeHF). Telemonitoring data and EHR will be analyzed with traditional regression models and machine learning for identifying predictive factors for i) death, ii) readmission for heart failure or other cardiovascular disease.

Significance: The study can contribute to more cost-effective, patient-centered, and medically purposeful care of heart failure.

Conditions

Interventions

DEVICE

Telemedicine

Patients receive equipment for report of vital signs and patient reported experience measures (PREMS), automatically transmitted via smartphone/bluetooth for six months (possible extension to 12 months in case of instability). A digital smartphone application is used for registration and transmission of data, including modes for asynchronous (chat) communication with the healthcare provider. Planned titration to OMT or diuretic adjustments may be done remotely depending on clinical assessment. The digital sensors include an electronic scale, pulse and blood pressure monitor for daily measurements by the patient.

Sponsors & Collaborators

  • Skaraborgs Hospital

    collaborator UNKNOWN
  • Southern Älvsborg Hospital

    collaborator OTHER
  • Sahlgrenska University Hospital

    lead OTHER

Principal Investigators

  • Helen Sjöland, MD, PhD · VGR, SU Sahlgrenska universitetssjukhuset

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-04-15
Primary Completion
2023-12-31
Completion
2023-12-31

Countries

  • Sweden

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06237998 on ClinicalTrials.gov