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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04327128
• Other study ID #: SMART HF II, Dnr 20 19-00378
• Status: Completed
• Phase: N/A
• Start date: May 29, 2019
• Est. completion date: April 30, 2021

Study information

• Verified date: June 2021
• Source: Lund University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: April 30, 2021
• Est. primary completion date: January 31, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Sweden	Lund University	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Lund University

Country where clinical trial is conducted

Sweden, 

Outcome

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