Telemedicine in Heart Failure; Treatment, Prognosis and Patient Experience

NCT06237998 | Completed

• 1 other identifier: Sahlgrenska UH
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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. 1.Reduce avoidable inpatient care and mortality.
2. 2.Optimize the escalation of medications to optimal medical therapy.
3. 3.Increase self-care and security.
4. 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.

Conditions

Heart Failure

Keywords

heart failure; telemedicine; treatment; progosis; patient experience

Outcome Measures

Primary Outcomes (4)

• Mortality

  All mortality and cardiovascular mortality

  up to 2 years after start of study

• Hospitalizations

  Re-hospitalizations, days hospitalized

  up to 2 years after start of study

• Number of contacts in out-patient clinical care

  Primary and specialized care

  up to 2 years after start of study

• EQ5D

  General health report containing 5 dimension of general health (graded 1-3) and a general comprehensive self-estimate of general health (0-100) where the highest values correspond to the highest level of general health.

  up to 2 years after start of study

Secondary Outcomes (2)

• Sense of security in care

  up to 2 years after start of study

• General self-efficacy scale

  up to 2 years after start of study

Study Arms (2)

Matched control group

Sex and age matched control group (5:1) from the Swedish heart failure register (1500 patients). No intervention.

Telemonitored group

Patients with new or worsening heart failure with, assessed to be in need of follow-up in a cardiology clinic (n=300).

Device: Telemedicine

Interventions

Telemedicine DEVICE

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.

Telemonitored group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Consecutive patients fulfilling the criteria above, treated in specialized heart failure clinics at Sahlgrenska University Hospital, Southern Älvsborg Hospital and Skaraborg Hospital.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Skaraborgs Hospital: collaborator
• Southern Älvsborg Hospital: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, 41685, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Helen Sjöland, MD, PhD

  VGR, SU Sahlgrenska universitetssjukhuset

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: January 11, 2024
• First Posted: February 2, 2024
• Study Start: April 15, 2020
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 6, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)