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COPDPhase 1TELECRAFTNCT02180919

Implementation of Telemonitoring in Chronic Heart or Lung Failure

A Phase 1 study testing CE marked Philips Motiva system in people with COPD and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
COPD, Heart Failure, Respiratory Failure
What is being tested?
CE marked Philips Motiva system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
85 participants
Where
2 sitesUnited Kingdom
Study dates
Jun 2010to Aug 2012
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United Kingdom2 sites
  • Royal Brompton Hospital

    London, SW3 6NP

  • West Middlesex University Hospita

    London

Other trials in United Kingdom

About this study

Official title: Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease

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.
Read the 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.

Being tested
CE marked Philips Motiva system
Keywords
Telemonitoring, COPD, Heart failure, Exacerbation, Respiratory failure, Prevention, Self monitoring
Medical subject headings
Pulmonary Disease, Chronic Obstructive, Heart Failure, Respiratory Insufficiency

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CE marked Philips Motiva systemDevice

    Telemonitoring will be carried out in the patient's home using the CE marked Philips Motiva system which comprises weight scales, blood pressure and heart rate monitoring, finger pulse oximeter and provides question/answer prompts all of which is linked to the patient's television screen and can be tuned into just as like a TV channel. Measurements of blood pressure, heart rate and weight will be obtained from the heart failure patients daily. In the respiratory patients heart rate and oximetry will be measured daily, and blood pressure and weight once a week.

Study groups in NCT02180919
Study groupRoleWhat they receive
Control periodNo interventionAll patients with receive standard optimal medical care according to ESC Heart Failure guidelines, NICE COPD guidelines or other best practice care pathways as relevant to their condition.
TelemonitoringExperimentaltelemonitoring will be carried out in the patient's home using the conformity European (CE) marked Philips Motiva system which comprises weight scales, blood pressure and heart rate monitoring, finger pulse oximeter and provides question/answer prompts all of which is linked to the patient's television screen and can be tuned into just as like a television (TV) channel. Measurements of blood pressure, heart rate and weight will be obtained from the heart failure patients daily. In the respiratory patients heart rate and oximetry will be measured daily, and blood pressure and weight once a week.
Receives: Device: CE marked Philips Motiva system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to first event

    Acute admission coded as due to acute exacerbation of heart failure/COPD, respiratory failure or mortality from heart failure/respiratory failure/COPD.

    Measured: at 6 months

Secondary outcomes (8)
  1. Compliance with telemonitoring

    Daily input into the Motiva system will be collected Monday to Friday. At the end of the study period the compliance with inputting the data on a daily basis will be averaged. This information will provide compliance with telemonitoring data.

    Measured: averaged over the expected 6 month period

  2. Self Efficacy

    The COPD patients will be asked to complete the Bristol COPD Knowledge Questionnaire before and after the 6 month period of telemonitoring, and the heart failure patients invited to complete the Self Care of Heart Failure index before and after telemonitoring.

    Measured: 0, 3, 6, 9 and 12 months

  3. Focus interviews

    Focus structured interviews will be carried out individually in the patient's home or at Royal Brompton Hospital after 6 and 12 months.

    Measured: 6 and 12 months after completion of the study

  4. Health care contacts

    GP consultations, emergency room visits will be recorded monthly in a self reported questionnaire

    Measured: 0,1,2,3,4,5,6,7,8,9,10,11 and 12 months

  5. Hospital Anxiety and Depression Score (HADS)

    The HADS score determines the levels of anxiety and depression that a patient is experiencing. The HADS is a fourteen item scale that generates ordinal data. Seven of the items relate to anxiety and seven relate to depression.

    Measured: 0, 3, 6, 9 and 12 months

  6. Minnesota Living with Heart Failure questionnaire

    Minnesota Living with Heart Failure questionnaire measures the effects of symptoms, functional limitations, psychological distress on an individual's quality of life, the Minnesota Living with Heart Failure questionnaire asks each person to indicate using a 6-point, zero to five, Likert scale how much each of 21 facets prevented them from living as they desired

    Measured: 0, 3, 6, 9 and 12 months

  7. The EuroQOL five dimensions questionnaire (EQ 5D)

    The self-assessment questionnaire is self-reported description of the subject's current health in 5 dimensions i.e., mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The subject is asked to grade their own current level of function in each dimension into one of three degrees of disability (severe, moderate or none).

    Measured: 0, 3, 6, 9 and 12 months

  8. Chronic Respiratory Disease Questionnaire (CRQ)

    The CRQ is a self-reported, disease specific measurement tool to assess health related quality of life (HRQL) in patients with chronic respiratory disease. Consists of 20 items across four dimensions: dyspnea, fatigue, emotional function, and mastery.

    Measured: 0, 3, 6, 9 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jul 2014 (estimated)
  2. Study startJun 2010
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
85 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02180919
Sponsor's protocol ID
10/H0704/19
Other IDs
10/H0704/19
Acronym
TELECRAFT
Status last verified
May 2010
First submitted
19 Jun 2014
Last updated
3 Jul 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 26962013

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing CE marked Philips Motiva system in people with COPD and Heart Failure, run by Royal Brompton & Harefield NHS Foundation Trust at 2 sites in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to first event (time frame: at 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02180919, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2014.

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