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

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: Heart Failure
• Intervention / Treatment: Device: LifePod

• Study Type: Interventional
• Enrollment (Actual): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Number of Arms

2

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	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

Collaborators and Investigators

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

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Heart Failure
• 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