Clinical trial NCT02180919: Implementation of Telemonitoring in Chronic Heart or Lung Failure
Official title: Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: COPD
Heart Failure
Respiratory Failure
Keywords: Telemonitoring
COPD
Heart failure
Exacerbation
Respiratory failure
Prevention
Self monitoring
Lead sponsor: Royal Brompton & Harefield NHS Foundation Trust
Sponsor class: OTHER
Collaborators: name: National Institute for Health Research, United Kingdom
First posted: 2014-07-03
Enrollment: 85
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: The aims of the study are to:

1. Implement a telemonitoring programme in heart failure and obstructive pulmonary disease (COPD) /chronic respiratory patients by assessing the real world impact of on readmissions, consults, home visits, quality of life and economic endpoints.
2. Explore the effects of telemonitoring across heart and respiratory groups with respect to i) factors that influence how patients integrate telemonitoring into their daily routines and self care behaviour and ii) how healthcare professionals use telemonitoring to aid decision- making.
3. Understand the impact of telemonitoring on a variety of care pathways.

Detailed description: BACKGROUND

Heart failure exacerbations consume 60-70% of costs for the condition and COPD exacerbations lead to 1:8 admissions so are costly to the NHS. The roll-out of telemonitoring in chronic disease is in line with NHS policy (Building Telecare in England; High Quality Care for All, national health service (NHS) next stage Darzi review).

Despite systematic reviews, the Whole System Demonstrator programme and randomised control trial (RCT) evidence in heart failure, the outcome of implementing telemonitoring is unclear, the evidence base in COPD is less consistent, and few studies have included economic analysis or investigated cross speciality implementation. An Italian trial found that telemedicine reduces chronic respiratory admissions by a third, but the Italian health service differs from the united kingdom (UK) system. The european union (EU) Commission Communication on telemedicine 2009 has stressed the need for new deployments to contribute to the evidence base in respiratory disease, and include a detailed analysis of the process changes that determine success. Our group has previously shown that telemonitoring reduces unplanned admissions in heart failure patients, and that elderly patients were able to cope well with the equipment. The investigators have also had experience with telesupport in chronic respiratory patients.

RATIONALE FOR CURRENT STUDY

The study will assess the implementation of a telemonitoring programme to demonstrate

1. whether home telemonitoring alerts patients and health professionals to exacerbations and reduces admissions,
2. if it can be reasonably implemented cross specialty,
3. the impact on quality of life of patients,
4. interaction between healthcare professionals, robustness of algorithms and self efficacy in patients.

The cross-over design allows sustained effects on self care and admissions to be assessed after removal of telemonitoring at 6 months in first groups treated. The acceptability of telemonitoring to healthcare workers and factors aiding and limiting integration into care pathways will be explored. Results should inform the commissioning of telemonitoring locally/nationally, facilitate buy-in from secondary and primary care teams, and optimise cost.

OVERALL DESIGN

Design: Crossover implementation study with patients allocated randomly 1:1 to telemonitoring or delayed entry to telemonitoring (after 6 months). All patients with receive standard optimal medical care according to European Society of Cardiology (ESC) Heart Failure guidelines, National Institute for Health and Care Excellence (NICE) COPD guidelines or other best practice care pathways as relevant to their condition. Each patient will receive home telemonitoring for 6 months. Comparisons will be carried out between patients with delayed entry (controls) and active telemonitoring. In the group receiving telemonitoring in first 6 month period the investigators will be able to assess impact of withdrawal in subsequent 6 months ie longer term benefit.

TELEMONITORING

Data from the monitors are delivered to the health care team members personal computer (PCs) using a dedicated broad band line which is installed in the patients home and is routed via a secure Philips Server. Each patient receives education in using the device until he or she and/or family/carer are fully confident. Via information displayed on their television screen each day patients are requested to answer interactive questions on level of breathlessness, sleep quality, phlegm production, wheeze. These results from each patient is used to create a warning system such that if all parameters are satisfactory this will appear as a green light; or for example, if a drop in arterial oxygen saturation and increase in wheeze, or increase in weight and increased breathlessness is seen the Motiva system will generate a red light for that patient which needs to be acted upon. It is an interactive system and therefore the healthcare team member can advise the patient through their screen (eg. increase dose of diuretic or oxygen flow rate, start antibiotic and steroids), or provide educational material eg. on inhaler use or exercise, and patients can respond. Patients will also be asked several questions once a week on whether they have consulted their general practitioner (GP), visited an Accident and Emergency Dept or been admitted to hospital.

Eligibility criteria: Inclusion Criteria:

* Heart failure patients: age \> 18 years who were in New York Heart Association class II-IV at time of discharge diagnosed by ESC guidelines.
* Respiratory patients: age \> 18 years with diagnosis of COPD or respiratory insufficiency due to chronic respiratory disorder diagnosed by Consultant Respiratory Physician (eg. bronchiectasis, chest wall disease, neuromuscular disorder) and arterial oxygen saturation value during most recent admission for exacerbation of 90% or below (or partial pressure of oxygen in arterial blood (PaO2) 8.0 kilopascal (kPa) or below) on air, or who fulfill criteria for, and receive long term oxygen therapy.

Exclusion Criteria:

* Age \<18 years.
* Cognitive impairment sufficient to interfere with use of telemonitoring system.

Primary outcomes:
measure: Time to first event
timeFrame: at 6 months
Secondary outcomes:
measure: Compliance with telemonitoring
timeFrame: averaged over the expected 6 month period
measure: Self Efficacy
timeFrame: 0, 3, 6, 9 and 12 months
measure: Focus interviews
timeFrame: 6 and 12 months after completion of the study
measure: Health care contacts
timeFrame: 0,1,2,3,4,5,6,7,8,9,10,11 and 12 months
measure: Hospital Anxiety and Depression Score (HADS)
timeFrame: 0, 3, 6, 9 and 12 months
measure: Minnesota Living with Heart Failure questionnaire
timeFrame: 0, 3, 6, 9 and 12 months
measure: The EuroQOL five dimensions questionnaire (EQ 5D)
timeFrame: 0, 3, 6, 9 and 12 months
measure: Chronic Respiratory Disease Questionnaire (CRQ)
timeFrame: 0, 3, 6, 9 and 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Royal Brompton Hospital
city: London
country: United Kingdom
facility: West Middlesex University Hospita
Study officials:
affiliation: Royal Brompton & Harefield NHS Foundation Trust
name: Anita K Simonds, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chatwin M, Hawkins G, Panicchia L, Woods A, Hanak A, Lucas R, Baker E, Ramhamdany E, Mann B, Riley J, Cowie MR, Simonds AK. Randomised crossover trial of telemonitoring in chronic respiratory patients (TeleCRAFT trial). Thorax. 2016 Apr;71(4):305-11. doi: 10.1136/thoraxjnl-2015-207045.