Phase 3
N=182
Home-HF: Evaluation of Patients With Heart Failure Using Home Telemonitoring
Heart Failure
Bottom Line
View on ClinicalTrials.gov: NCT00312884 ↗Enrolled (actual)
182
Serious AEs
30.8%
Results posted
May 2016
Primary outcome: Primary: Days Alive and Outside of Hospital — 180; 178 Days
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- HomMed Telemonitoring System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Imperial College London
- Primary completion
- Sep 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days Alive and Outside of Hospital |
180; 178 | — |
| PRIMARY Patients Hospitalised (All Cause) |
23; 33 | — |
| PRIMARY Number of Days Spent in Hospital |
17; 13 | — |
| PRIMARY Number of Hospitalisations (All Cause) |
39; 44 | — |
Summary
This project, using home monitoring for the signs and symptoms of heart failure, aims to empower patients to be actively involved in their care and provide rapid access to healthcare services and advice when needed. The telemonitoring system is easy to use and ensures the accurate transfer of information from the home to the hospital. The information is then screened and if important changes are seen, the patient will be contacted by a heart failure nurse who will offer advice and may arrange a clinic visit or suggest alterations to the medication. The project uses modern technology to provide disease management, links the patient in their home with the hospital and reinforces education and self-care behaviour. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital, reduces anxiety, improves quality of life following a hospital admission for heart failure and whether this represents good value for money in terms of the health benefits it provides.
Hypothesis:
Patients using home telemonitoring of signs and symptoms of heart failure following discharge from hospital with chronic heart failure have a reduced risk of all-cause re-hospitalisation when compared with usual care.
Eligibility Criteria
Inclusion Criteria
- NYHA class II - IV (i.e. breathlessness at rest or on mild-moderate exercise) at time of randomisation (hospital discharge)
- Proven diagnosis of heart failure, in line with the guidelines for management of chronic heart failure of the European Society of Cardiology or as determined by the cardiologist or physician caring for the patient
- Admission to hospital following a new diagnosis of heart failure or episode of acute decompensation of chronic heart failure
- Home telephone line
- Deemed fit for discharge home by the clinical team
Exclusion Criteria
- Dementia/confusion which is likely to interfere with the use of the HomMed telemonitoring equipment.
- < 18 years of age
- Lack of home telephone line
Data sourced from ClinicalTrials.gov (NCT00312884). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.