NCT04327128

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started May 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 29, 2019

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 15, 2020

Completed
15 days until next milestone

First Posted

Study publicly available on registry

March 30, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

1.7 years

First QC Date

March 15, 2020

Last Update Submit

June 28, 2021

Conditions

Heart Failure

Outcome Measures

Primary Outcomes (6)

  • 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

  • Cardiovascular events and deaths

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

    12 month

  • 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

  • Health care visits

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

    12 months

  • 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

  • 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

Study Arms (2)

Intervention group

ACTIVE COMPARATOR

Standard heart failure care and a digital heart failure support system

Device: LifePod

Control group

OTHER

Standard heart failure care

Device: LifePod

Interventions

LifePodDEVICE

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

Control groupIntervention group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • It is assessed that they can handle the intervention themselves or with the help of personal or relatives.
  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lund University

Lund, Skåne County, 22100, Sweden

Location

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Sofia Gerward, MD, PhD

    Lund University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 15, 2020

First Posted

March 30, 2020

Study Start

May 29, 2019

Primary Completion

January 31, 2021

Study Completion

April 30, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Locations

SE(1)