Evaluation of Remote Patient Monitoring.

This study has been withdrawn prior to enrollment.
(Nottingham PCT withdrew for financial reasons)
Sponsor:
Collaborator:
Nottingham City Primary Care Trust
Information provided by (Responsible Party):
Malcolm Clarke, Brunel University
ClinicalTrials.gov Identifier:
NCT00789100
First received: November 10, 2008
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

Nottingham Primary Care Trust has launched telemonitoring to support: independent living and self-management ability of people with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities; and reduce the health care utilisation associated with these patients, including the number of hospitalisations, GP visits and community matron and specialist community nurse home visits.

The Multidisciplinary Assessment of Technology Centre for Healthcare (MATCH) will evaluate the technology and its impact of this telemonitoring system on quality of care (i.e. process measures), patient outcomes and direct healthcare costs from an NHS perspective.


Condition
Congestive Heart Failure
Chronic Obstructive Pulmonary Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of a Home-based Telemonitor Service

Resource links provided by NLM:


Further study details as provided by Brunel University:

Primary Outcome Measures:
  • Hospitalizations, hospital days, encounters with health professionals [ Time Frame: Collected until end date ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: February 2009
Study Completion Date: February 2011
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Group provided with home-based monitor
2
Group receives no home-based monitor

Detailed Description:

The study is designed to evaluate the impact of home-based monitoring to support community based nursing services and care matrons in the management of patients with CHF and COPD and co-morbidities. The main issue is to design a study that will determine the impact of the use of the technology independent of other factors. A randomised controlled trial has been chosen in which equal numbers of participants with and without home-based monitoring will be followed over the study to determine differences in utilisation of healthcare services including number of hospitalisations, length of stay in hospital, GP visits and community matron and specialist community nurse home visits.

The ethical issue is how to determine those that will receive home-based monitoring and those that will be denied. The study requires that participants are matched for severity of their condition in each arm and this could deny some from the potential benefits of monitoring. However, as only a limited number of home-based monitors are available and all participants will continue to receive normal health care services, we believe that those denied monitoring will not receive care that is different to patients not in the study and the ethical issues are acceptable.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients with congestive heart failure (CHF), chronic obstructive pulmonary disease (COPD) and co-morbidities referred to the community specialist nurse or care matron

Criteria

Inclusion Criteria:

  • Participants selected will be those: diagnosed with CHF, COPD or co-morbidities and referred to the community management service by its selection procedure for severity of the condition; are considered eligible for home-based telemonitoring; consent to receiving telemonitoring; have an active phone connection; are able to read and speak English (language of the equipment); are capable and willing to use the home monitoring device.

Exclusion Criteria:

  • Patients are considered ineligible: if they have psychological or psychiatric disorders; if they have a cognitive deficiency that makes them unable to participate in their self-treatment; if they have a visual or motor deficiency that renders them incapable of using the telemonitoring device (unless a spouse or an informal caregiver is able to help); if they are currently scheduled for a hospital admission; if their life expectancy is shorter than 2 years; or if they already participate in another study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789100

Locations
United Kingdom
Nottingham PCT
Nottingham, Nottinghamshire, United Kingdom
Sponsors and Collaborators
Brunel University
Nottingham City Primary Care Trust
Investigators
Principal Investigator: Malcolm Clarke, PhD Brunel University
  More Information

No publications provided

Responsible Party: Malcolm Clarke, Reader, Brunel University
ClinicalTrials.gov Identifier: NCT00789100     History of Changes
Other Study ID Numbers: Nottingham-001
Study First Received: November 10, 2008
Last Updated: July 15, 2014
Health Authority: United Kingdom: National Health Service

Keywords provided by Brunel University:
telehealth
telemonitor
telemedicine
Co-morbidities

Additional relevant MeSH terms:
Heart Failure
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 20, 2014