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OpenTrials
Completed

NCT Number: NCT04327128

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

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

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Key information

Conditions

Heart Failure Cardiovascular Diseases Heart Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lund University

Lund, Skåne County, 22100, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

LifePod

Device

The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider

Primary outcomes

  1. Self-care behaviour

    Time frame: 6 month

    Improvement in self-care behaviour measured by the questionnaire European Heart Failure Self-care behaviour scale (EHFScB-9) A higher EHFScB-9 score indicates a worse self-care behaviour. The minimum score is 9 points and the maximum score is 45.

  2. Cardiovascular events and deaths

    Time frame: 12 month

    Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion

  3. Hospitalization and hospital days

    Time frame: 12 months

    Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion

  4. Health care visits

    Time frame: 12 months

    Type and number of health care visits during intervention and up to 12 months after inclusion

  5. Patient-reported symptoms

    Time frame: 6 months

    Improved patient-reported symptoms as measured by questionnaire EuroQol three-dimensional questionnaire (EQ-5D-3L ) where high score represent worse symptoms. The minimum score is 7 points and the maximum score is 23 points.

  6. Quality of life

    Time frame: 6 months

    Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life

Sponsors and collaborators

Lead sponsor

Lund University

Other

Registry information

Official study title

Evaluation of a Digital Support and Communication Platform for Heart Failure:

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Mar 30, 2020
Registry last updated
Jul 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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