Implementation of Telemonitoring in the Management of Acute Exacerbations of Chronic Heart Failure and Respiratory Failure/Chronic Obstructive Pulmonary Disease
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 85
- Locations
- 2
- Primary Endpoint
- Time to first event
Study Overview
Brief Summary
The aims of the study are to:
- 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.
- 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.
- 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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
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.
Intervention: CE marked Philips Motiva system (Device)
Outcomes
Primary Outcomes
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 Outcomes
- Compliance with telemonitoring(averaged over the expected 6 month period)
- 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)
- Chronic Respiratory Disease Questionnaire (CRQ)(0, 3, 6, 9 and 12 months)
- Self Efficacy(0, 3, 6, 9 and 12 months)
- Minnesota Living with Heart Failure questionnaire(0, 3, 6, 9 and 12 months)
- The EuroQOL five dimensions questionnaire (EQ 5D)(0, 3, 6, 9 and 12 months)