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

NCT ID: NCT04327128

Last Updated: 2021-07-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-29

Study Completion Date

2021-04-30

Brief Summary

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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

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Caregivers Investigators

Study Groups

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Intervention group

Standard heart failure care and a digital heart failure support system

Group Type ACTIVE_COMPARATOR

LifePod

Intervention Type DEVICE

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

Control group

Standard heart failure care

Group Type OTHER

LifePod

Intervention Type DEVICE

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

Interventions

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LifePod

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Lund University

OTHER

Sponsor Role lead

Responsible Party

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Sofia Gerward

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sofia Gerward, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Lund University

Locations

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Lund University

Lund, Skåne County, Sweden

Site Status

Countries

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Sweden

Other Identifiers

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SMART HF II, Dnr 20 19-00378

Identifier Type: -

Identifier Source: org_study_id

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