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

June 28, 2021 updated by: Sofia Gerward, Lund University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden, 22100
        • Lund University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Intervention group
Standard heart failure care and a digital heart failure support system
Device: LifePod
The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider
OTHER: Control group
Standard heart failure care
Device: LifePod
The intervention group is testing LifePod on a digital communication platform between patient and healthcare provider

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 month
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
12 month
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
12 months
Health care visits
Time Frame: 12 months
Type and number of health care visits during intervention and up to 12 months after inclusion
12 months
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 months
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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University

Investigators

  • Principal Investigator: Sofia Gerward, MD, PhD, Lund University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 29, 2019

Primary Completion (ACTUAL)

January 31, 2021

Study Completion (ACTUAL)

April 30, 2021

Study Registration Dates

First Submitted

March 15, 2020

First Submitted That Met QC Criteria

March 27, 2020

First Posted (ACTUAL)

March 30, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 1, 2021

Last Update Submitted That Met QC Criteria

June 28, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMART HF II, Dnr 20 19-00378

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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