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Patient-centred Home-based Management of Heart Failure

NCT03655496 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2018-09-04

No results posted yet for this study

Summary

A novel home-based tool for self-management is to be evaluated for heart failure patients. The tool assists the patient with symptom monitoring, education and titration of diuretics. Patients who were recently hospitalized for heart failure will be randomized to receiving the tool or standard care for six months. The primary end-point will be self-care behaviour, as measured with the validated instrument the European Heart failure self-care behaviour Scale 9-item questionnaire (Jaarsma et al). Secondary end-points are in-hospital days due to heart failure, quality of life (general and disease-specific) as measured by the SF-36 and KCCQ questionnaires, and finally knowledge about heart failure, assessed by the Dutch Heart Failure Knowledge Scale.

Conditions

Interventions

DEVICE

Home-based tool

The tool consists of a tablet computer and a Bluetooth connected weight scale. The patient is encouraged to use the tool daily. The weight is titrates the dose of diuretics and a short tip about how to improve living with heart failure, this is presented on the screen. Every five days the patient assess their self-perceived symptoms on the tablet computer. If the weight increases by 2kg or more in 3 days or less, the high dose is recommended for two days, after which the effect on the weight is assessed. If the weight increased was reverted, the dose is returned to normal and if it is still elevated, an alert on the table computer. If the self-assessed symptoms deteriorate, the same type of alert will appear on screen, urging the patient to contact the health care provider.

Sponsors & Collaborators

  • Karolinska University Hospital

    collaborator OTHER

  • Danderyd's hospital

    collaborator UNKNOWN

  • Stockholm South General Hospital

    collaborator OTHER

  • CareLigo AB

    lead INDUSTRY

Principal Investigators

  • Inger Hagerman, PhD · Karolinska University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-22
Primary Completion
2013-12-18
Completion
2013-12-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03655496 on ClinicalTrials.gov