ClinicalTrials.Veeva

Menu

Selfcare MAnagement InteRvenTion in Heart Failure II (SMART HF II)

L

Lund University

Status

Completed

Conditions

Heart Failure

Treatments

Device: LifePod

Study type

Interventional

Funder types

Other

Identifiers

NCT04327128
SMART HF II, Dnr 20 19-00378

Details and patient eligibility

About

The purpose of the study is to evaluate if the digital support and communication platform for heart failure can provide patients with heart failure increased knowledge, compliance and quality of life and thus affect re-admissions and visit structure.

To evaluate whether a digital support and communication platform for heart failure patients after 6 months can provide:

  1. Improved self-care
  2. Improved quality of life and reduced number of patient-assessed symptoms
  3. Reduction in the number of cardiovascular events, hospital nights, the number of hospitalizations or the number of deaths and out-patient visits

Enrollment

70 patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosed heart failure I.50 (newly discovered or existing) in NYHA Class I-IV in principle with ESC guidelines 2016.

    • Have completed the "consent form" or consent form, see §4.2 Exclusion criteria: * Patient who refuses to participate in the trial.
    • It is assessed that they can handle the intervention themselves or with the help of personal or relatives.

Exclusion criteria

  • Patient who declines to participate in the trial.

    • Impaired cognitive ability that is judged to affect the ability to conduct the study in the intended manner.
    • Life expectancy <8 months
    • In other ways, by the treating physician, it is deemed inappropriate to participate in the study, e.g. due to participation in another study.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

70 participants in 2 patient groups

Intervention group
Active Comparator group
Description:
Standard heart failure care and a digital heart failure support system
Treatment:
Device: LifePod
Control group
Other group
Description:
Standard heart failure care
Treatment:
Device: LifePod

Trial contacts and locations

1

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems