Study Stopped
The study was ended before any patients were enrolled. Department of Clinical Research, August 2020.
Congestive Heart Failure Home Telemonitoring
1 other identifier
interventional
N/A
1 country
1
Brief Summary
Remote monitoring of chronic heart failure can reduce deaths and hospitalisations, and may provide benefits on health care costs and quality of life. Currently there is limited use of remote monitoring for heart failure in Norway. The funding streams and the structure of the norwegian health service is different from other countries that have tried remote monitoring and therefore it is important to examine the utility of such services in Norway. The study is a randomised controlled trial that will allow participants in the intervention group to use a wireless weight scale and blood pressure monitor device that will send automatically the measurements electronically and securely to the Heart Failure Outpatient Clinic of the hospital.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Feb 2014
Shorter than P25 for not_applicable heart-failure
1 active site
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
October 30, 2013
CompletedFirst Posted
Study publicly available on registry
January 29, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2015
CompletedJune 22, 2021
January 1, 2014
11 months
October 30, 2013
June 16, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
CHF related hospital readmissions
12 months
Secondary Outcomes (4)
Length of stay
12 months
Quality of Life MLwHF
6 months, 12 months
Challenges and opportunities
12 months
Additional costs/savings resulting from the service
12 months
Study Arms (2)
Telemonitoring
EXPERIMENTALDevice: Weight and blood pressure device Device: Home telemonitoring device
Control
NO INTERVENTIONUsual care
Interventions
Weight and blood pressure device integrated in a home telemonitoring kit. The weight scale is Withings The Smart Bodyscale. The blood pressure device is MEDISANA iHealth BP3.
An iPad 2 WiFi 16GB (Model A1395) tablet integrating the telemonitoring kit.
Eligibility Criteria
You may qualify if:
- the presence of CHF signs and symptoms such as dyspnoea and peripheral or pulmonary oedema requiring diuretic administration (New York Heart Association \[NYHA\] functional class II-IV); and
- ejection fraction (EF) under 40% combined or not with a left ventricular filling pattern supporting the presence of diastolic dysfunction, according to the American College of Cardiology/American Heart Association Guidelines for chronic heart failure.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital of North Norwaylead
- Helse Nordcollaborator
Study Sites (1)
University Hospital of North Norway
Tromsø, 9038, Norway
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Artur Serrano, PHD
Norwegian Centre for Integrated Care and Telemedicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2013
First Posted
January 29, 2014
Study Start
February 1, 2014
Primary Completion
January 1, 2015
Study Completion
January 1, 2015
Last Updated
June 22, 2021
Record last verified: 2014-01