NCT04084964

Brief Summary

This feasibility study is part of a larger interregional European project (NWE-Chance) financially supported by the 'Interreg North West Europe' program to develop and validate promising integrated eHealth applications combined with nanotechnology for hospitalisation of heart failure patients at home. For more information on this research project and the partners see http://www.nweurope.eu/nwe-chance

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
66

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Oct 2020

Shorter than P25 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 5, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 10, 2019

Completed
1.1 years until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 15, 2022

Status Verified

March 1, 2022

Enrollment Period

1.1 years

First QC Date

September 5, 2019

Last Update Submit

March 14, 2022

Conditions

Outcome Measures

Primary Outcomes (5)

  • Acceptability will be assessed with the SUTAQ questionnaire adapted for home-hospitalisation

    The SUTAQ or the Service User Technology Acceptability Questionnaire is to measure acceptability and identify the characteristics of persons who were likely to reject technological health services Will be assessed after the home-hospitalisation in patients and staff. There are 20 questions that can be answered with 6 answer possibilities ranging from fully disagree to fully agree. These answered will be coded to numbers ranging from 1-6 (6 is fully agree, 1 fully disagree). The total score is 120 and the range for the score can be 20-120

    5-14 days

  • Usability will be assessed with the SUS questionnaire adapted for home-hospitalisation

    SUS or the System Usability Scale will be used after the home-hospitalisation to assess the usability of the platform for the patients and staff. There are 10 questions in total with 5 answer possibilities ranging from totally agree to fully disagree. The answers will be coded to numbers (1-5) and 5 means totally agree and 1 is fully disagree. The total score is 50 and the range for the score can be 10-50

    5-14 days

  • Satisfaction will be assessed with the Satisfaction Home-hospitalisation program questionnaire

    The satisfaction of the home-hospitalisation program questionnaire consist of 19 questions and will be used to assess the satisfaction of patients. There are 5 answer possibilities ranging from completely satisfied to very dissatisfied. The answers will be coded to numbers (1-5) and 5 means completely satisfied and 1 is very dissatisfied. The total score is 95 and the range for the score can be 19-95

    5-14 days

  • Platform use will be assessed with the amount of logs in the patient application

    5-14 days

  • Number of adverse events will be mapped by the study team

    30 days

Study Arms (1)

Study group

EXPERIMENTAL

These patients receive the home-hospitalisation platform

Other: Home-hospitalisation platform for heart failure

Interventions

The primary objective of the INTERREG NWE-Chance project is the development of an integrated home-hospitalisation platform and the assessment of the feasibility of a home hospitalisation strategy for heart failure patients.

Study group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with known and well assessed chronic heart failure.
  • Age\>18 years
  • (Indication for) hospital admission for acute decompensated heart failure
  • Living within a wide proximity of the hospital (differs per centre)
  • Living independently and/or sufficiently supported at home and/or living in nursing homes (or other supported living modalities).

You may not qualify if:

  • Indication for IC/CCU admission;
  • Contraindication to Chance@Home;
  • Mental impairment leading to inability to cooperate;
  • Severe comorbidity requiring simultaneous hospital care;
  • History of severe liver / kidney disease;
  • Unstable blood pressure (systolic blood pressure \<90mmHg);
  • Unstable heart rhythm (in case of sinus rhythm, heart rate \>110/min, in case of atrial fibrillation \>150/min);
  • Need for intravenous inotropic medication;
  • Unstable respiratory condition (sO2 \<90% without additional O2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa Hospital

Hasselt, Belgium

Location

Related Publications (1)

  • Leenen JPL, Scherrenberg M, Bruins W, Boyne J, Vranken J, Brunner la Rocca HP, Dendale P, van der Velde AE. Usability of a digital health platform to support home hospitalization in heart failure patients: a multicentre feasibility study among healthcare professionals. Eur J Cardiovasc Nurs. 2024 Mar 12;23(2):188-196. doi: 10.1093/eurjcn/zvad059.

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: The NWE-Chance feasibility study is an international, multicenter, single-arm prospective and interventional study.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 5, 2019

First Posted

September 10, 2019

Study Start

October 1, 2020

Primary Completion

November 1, 2021

Study Completion

December 1, 2021

Last Updated

March 15, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations