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NCT06237998Completed

Telemedicine in Heart Failure; Treatment, Prognosis and Patient Experience

Telemedicine in Heart Failure: Studies of Treatment, Prognosis and Patient Experience

Source: ClinicalTrials.gov · Last updated 6 Feb 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Study type
Observational
Enrollment
300 (actual)
First submitted
11 Jan 2024
Start date
15 Apr 2020
Primary completion date
31 Dec 2023
Lead sponsor
Sahlgrenska University Hospital
NCT number
NCT06237998

What you commit to

  • Study type: Observational
  • Participants enrolled: 300
  • From 15 Apr 2020 to the primary completion date, 31 Dec 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other

  • Insufficient understanding of spoken or written Swedish, and no access to assistance
  • Lacking cognitive and physical ability to handle equipment and make measurements
  • Not motivated to participate
  • Does not hold a national digital identification: Mobilt BankID
  • Does not have smartphone
  • No internet availability in home
  • Not followed at the participating cardiology clinics
  • Palliative care or planned care that will interfere with patient´s participation

Who the study is looking for

  • Newly diagnosed heart failure requiring titration of medication
  • Heart failure with decompensation: ≥1 hospitalization during the preceding 12 months
  • Heart failure with decompensation: worsening between clinical controls

Criteria the registry did not label

  • Consecutive HF patients (≥18 years) at specialized HF clinics are being recruited for intervention.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Sahlgrenska University Hospital
Coordinator of this site? Confirm its status
GothenburgSwedenUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.