Heart Failure
Conditions
Keywords
telemonitoring, heart failure, randomised, hospitalisation, HomMed
Brief 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.
Detailed description
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. This innovative programme will be tested to see if it reduces the risk of re-admission to hospital. In addition economic evaluation will assess whether this represents good value for money in terms of the health benefits it provides. After fulfilling the inclusion criteria and being consented into the study, the patients will be randomised into either the control or intervention group in a 1:1 ratio. Intervention Group: Prior to hospital discharge the patient and carer/family will be shown how to use the HomMed Telemonitoring equipment. Within two working days of discharge the equipment will be installed in their home by the study nurse who will remind them of its use. They will be provided with a written management plan and advice regarding self-monitoring.They will be asked to monitor signs and symptoms of their disease daily using the HomMed telemonitoring system connected to their home phone line. The data will be reviewed every working day by a study nurse and examined for variance from the agreed parameters. If clinically significant changes are noted a standard protocol will be used to guide the management. Control group: Within two working days of discharge the study nurse will visit patients in the control group and provide them with a written management plan and advice regarding self-monitoring. They will receive usual care for that centre which will consist of a recommendation to visit their GP on hospital discharge and a subsequent review in the outpatient clinic. Informal support offered through the hospital heart failure nurse will continue and this contact will be recorded. Within both groups the Hospital Anxiety and Depression (HAD) questionnaire, the Minnesota Living with Heart Failure(MLWHF) tool and the Euroqol (EQ-5D) questionnaire will be completed at randomisation, and again at 3 and 6 months following hospital discharge. They will be asked to return completed questionnaires in a pre-paid envelope. Data on patients' use of healthcare services will be collected from both groups using a combination of retrospective questionnaires and prospective health diaries, which will be returned at 3 and 6 months after randomisation. Drug optimisation will be assessed through review of medication prescription, and drug utilisation through patient self-report.These data will also be collected at 3 and 6 months. Patients within both groups will be involved in the study for a period of 6 months.
Interventions
DEVICEHomMed Telemonitoring System
The HomMed telemonitoring system allows for patients to monitor their weight, blood pressure, oxygen saturation and symptoms of dyspnoea on a daily basis from their home
Sponsors
Honeywell HomMed
Imperial College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Days Alive and Outside of Hospital | From date of randomisation for 180 days | Days alive and outside of hospital (i.e. not admitted) |
| Patients Hospitalised (All Cause) | From randomisation date to 180 days | — |
| Number of Days Spent in Hospital | From randomisation date for 180 days | — |
| Number of Hospitalisations (All Cause) | from randomisation for 180 days | — |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Usual Care Recieved usual follow-up care | 91 |
| Intervention Arm Received daily home monitoring | 91 |
| Total | 182 |
Baseline characteristics
| Characteristic | Intervention Arm | Usual Care | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 61 Participants | 61 Participants | 122 Participants |
| Age, Categorical Between 18 and 65 years | 30 Participants | 30 Participants | 60 Participants |
| Age, Continuous | 70 years STANDARD_DEVIATION 12.8 | 72 years STANDARD_DEVIATION 10.4 | 71 years STANDARD_DEVIATION 11 |
| Region of Enrollment United Kingdom | 91 participants | 91 participants | 182 participants |
| Sex: Female, Male Female | 29 Participants | 32 Participants | 61 Participants |
| Sex: Female, Male Male | 62 Participants | 59 Participants | 121 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 10 / 91 | 17 / 91 |
| serious Total, serious adverse events | 23 / 91 | 33 / 91 |
Outcome results
Primary
Days Alive and Outside of Hospital
Days alive and outside of hospital (i.e. not admitted)
Time frame: From date of randomisation for 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Days Alive and Outside of Hospital | 180 Days |
| Intervention Arm | Days Alive and Outside of Hospital | 178 Days |
Primary
Number of Days Spent in Hospital
Time frame: From randomisation date for 180 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Usual Care | Number of Days Spent in Hospital | 17 days |
| Intervention Arm | Number of Days Spent in Hospital | 13 days |
Primary
Number of Hospitalisations (All Cause)
Time frame: from randomisation for 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Number of Hospitalisations (All Cause) | 39 Number of hospitalisations |
| Intervention Arm | Number of Hospitalisations (All Cause) | 44 Number of hospitalisations |
Primary
Patients Hospitalised (All Cause)
Time frame: From randomisation date to 180 days
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Usual Care | Patients Hospitalised (All Cause) | 23 participants |
| Intervention Arm | Patients Hospitalised (All Cause) | 33 participants |