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Clinical Trials/NCT04327128
NCT04327128
Completed
Not Applicable

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

Lund University1 site in 1 country70 target enrollmentMay 29, 2019
ConditionsHeart Failure

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Heart Failure
Sponsor
Lund University
Enrollment
70
Locations
1
Primary Endpoint
Self-care behaviour
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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
Registry
clinicaltrials.gov
Start Date
May 29, 2019
End Date
April 30, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Sofia Gerward

Principal Investigator

Lund University

Eligibility Criteria

Inclusion Criteria

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

Outcomes

Primary Outcomes

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.

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

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

Health care visits

Time Frame: 12 months

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

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.

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

Study Sites (1)

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