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

Not Applicable

Completed

• Conditions: Heart Failure
• Interventions: Device: LifePod

• Registration Number: NCT04327128
• Lead Sponsor: Lund University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-29
• Study First Submitted: 2020-03-15
• Study First Submitted QC: 2020-03-27
• Study First Posted: 2020-03-30
• Primary Completion: 2021-01-31
• Study Completion: 2021-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-28
• Last Update Posted: 2021-07-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	LifePod	Standard heart failure care and a digital heart failure support system
Control group	LifePod	Standard heart failure care

Primary Outcome Measures

Name	Time	Method
Self-care behaviour	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	12 month	Number of participants with cardiovascular events and deaths during intervention and up to 12 months after inclusion
Hospitalization and hospital days	12 months	Number of participants with new hospitalization and number of hospital days during intervention and up 12 months after inclusion
Health care visits	12 months	Type and number of health care visits during intervention and up to 12 months after inclusion
Patient-reported symptoms	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	6 months	Improved quality of life as measured on visual analogue scale 0-100 where high figure represent best quality of life

Trial Locations

Locations (1)

Lund University; 🇸🇪 Lund, Skåne, Sweden