Implementation of Telemonitoring in Chronic Heart or Lung Failure

NCT02180919 | Completed Phase 1

• 1 other identifier: 10/H0704/19
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 2

Brief Summary

The aims of the study are to:

1. 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. 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. 3.Understand the impact of telemonitoring on a variety of care pathways.

Conditions

COPD; Heart Failure; Respiratory Failure

Keywords

Telemonitoring; COPD; Heart failure; Exacerbation; Respiratory failure; Prevention; Self monitoring

Outcome Measures

Primary Outcomes (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.

  at 6 months

Secondary Outcomes (8)

• Compliance with telemonitoring

  averaged over the expected 6 month period

• Self Efficacy

  0, 3, 6, 9 and 12 months

• Focus interviews

  6 and 12 months after completion of the study

• Health care contacts

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

• Hospital Anxiety and Depression Score (HADS)

  0, 3, 6, 9 and 12 months

Study Arms (2)

Control period

NO INTERVENTION

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.

Telemonitoring

EXPERIMENTAL

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

Interventions

CE marked Philips Motiva system DEVICE

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.

Telemonitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• National Institute for Health Research, United Kingdom: collaborator

Study Sites (2)

Royal Brompton Hospital

London, SW3 6NP, United Kingdom

Location

West Middlesex University Hospita

London, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 26962013 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Heart Failure; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Heart Diseases; Cardiovascular Diseases; Respiration Disorders

Study Officials

• Anita K Simonds, MD

  Royal Brompton & Harefield NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2014
• First Posted: July 3, 2014
• Study Start: June 1, 2010
• Primary Completion: August 1, 2012
• Study Completion: August 1, 2012
• Last Updated: July 3, 2014

Record last verified: 2010-05

Locations

GB (2)