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Selfcare Management Intervention in Heart Failure

NCT03484286 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 124

Last updated 2021-04-12

No results posted yet for this study

Summary

A novel tool for self-care enhancement for heart failure (HF) patients has been developed. In this randomized controlled trial, patients will be randomized 1:1 to either receive the home-based tool (OPTILOGG) or standard care. The intervention will go on for 8 months, and outcomes are self-care, cardiovascular events (including emergency visits, admissions, number of in-hospital days).

Conditions

Interventions

DEVICE

OPTILOGG

OPTILOGG is a CE marked class 1m medical device. It consists of a tablet computer and a wirelessly connected weight scale. The system will have some patient specific information regarding the flexible (loop-) diuretics scheme. The patient will be asked to step on the weight scale daily, and will be shown to some brief information on how to live better with HF, as well as the recommended dose of diuretics that specific day. Every five days the patient will answer three questions about his/her symptoms, namely shortness of breath, fatigue and peripheral edema. The system also contains information that the patient can study at his/her leisure. If the system detects a deterioration in HF status, the patient is encouraged to contact his/her health care provider via telephone.

OTHER

Standard care

Patients in the control group will be subject to standard heart failure care.

Sponsors & Collaborators

  • Region Skane

    collaborator OTHER

  • Lund University

    lead OTHER

Principal Investigators

  • Sofia Gerward, PhD · Lund University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-03
Primary Completion
2019-10-18
Completion
2019-12-13

Countries

  • Sweden

Study Locations

More Related Trials

Entities

Diseases

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 NCT03484286 on ClinicalTrials.gov