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Implementation of Telemonitoring in Chronic Heart or Lung Failure (TELECRAFT)

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ClinicalTrials.gov Identifier: NCT02180919
Recruitment Status : Completed
First Posted : July 3, 2014
Last Update Posted : July 3, 2014
Sponsor:
Collaborator:
National Institute for Health Research, United Kingdom
Information provided by (Responsible Party):
Royal Brompton & Harefield NHS Foundation Trust

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.

Condition or disease Intervention/treatment Phase
COPD Heart Failure Respiratory Failure Device: CE marked Philips Motiva system Phase 1

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
Study Start Date : June 2010
Actual Primary Completion Date : August 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: Control period
All 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.
Experimental: Telemonitoring
telemonitoring 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.
Device: CE marked Philips Motiva system
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.




Primary Outcome Measures :
  1. Time to first event [ Time Frame: at 6 months ]
    Acute admission coded as due to acute exacerbation of heart failure/COPD, respiratory failure or mortality from heart failure/respiratory failure/COPD.


Secondary Outcome Measures :
  1. Compliance with telemonitoring [ Time Frame: averaged over the expected 6 month period ]
    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.

  2. Self Efficacy [ Time Frame: 0, 3, 6, 9 and 12 months ]
    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.

  3. Focus interviews [ Time Frame: 6 and 12 months after completion of the study ]
    Focus structured interviews will be carried out individually in the patient's home or at Royal Brompton Hospital after 6 and 12 months.

  4. Health care contacts [ Time Frame: 0,1,2,3,4,5,6,7,8,9,10,11 and 12 months ]
    GP consultations, emergency room visits will be recorded monthly in a self reported questionnaire

  5. Hospital Anxiety and Depression Score (HADS) [ Time Frame: 0, 3, 6, 9 and 12 months ]
    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.

  6. Minnesota Living with Heart Failure questionnaire [ Time Frame: 0, 3, 6, 9 and 12 months ]
    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

  7. The EuroQOL five dimensions questionnaire (EQ 5D) [ Time Frame: 0, 3, 6, 9 and 12 months ]
    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).

  8. Chronic Respiratory Disease Questionnaire (CRQ) [ Time Frame: 0, 3, 6, 9 and 12 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02180919


Locations
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United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6NP
West Middlesex University Hospita
London, United Kingdom
Sponsors and Collaborators
Royal Brompton & Harefield NHS Foundation Trust
National Institute for Health Research, United Kingdom
Investigators
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Principal Investigator: Anita K Simonds, MD Royal Brompton & Harefield NHS Foundation Trust

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Royal Brompton & Harefield NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT02180919     History of Changes
Other Study ID Numbers: 10/H0704/19
10/H0704/19 ( Other Identifier: Royal Brompton Hospital REC/research office )
First Posted: July 3, 2014    Key Record Dates
Last Update Posted: July 3, 2014
Last Verified: May 2010

Keywords provided by Royal Brompton & Harefield NHS Foundation Trust:
Telemonitoring
COPD
Heart failure
Exacerbation
Respiratory failure
Prevention
Self monitoring

Additional relevant MeSH terms:
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Heart Failure
Respiratory Insufficiency
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases