Telehealth Evaluation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Brunel University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Nottingham City PCT
Information provided by:
Brunel University
ClinicalTrials.gov Identifier:
NCT00789100
First received: November 10, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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 ]

Estimated Enrollment: 500
Study Start Date: February 2009
Estimated Study Completion Date: February 2011
Estimated 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00789100

Contacts
Contact: Malcolm Clarke, PhD +44 1895 265053 malcolm.clarke@brunel.ac.uk

Locations
United Kingdom
Nottingham PCT Not yet recruiting
Nottingham, Nottinghamshire, United Kingdom
Contact: Malcolm Clarke, PhD    +44 1895 265053    malcolm.clarke@brunel.ac.uk   
Principal Investigator: Malcolm Clarke, PhD         
Sponsors and Collaborators
Brunel University
Nottingham City PCT
Investigators
Principal Investigator: Malcolm Clarke, PhD Brunel University
  More Information

No publications provided

Responsible Party: Malcolm Clarke, Brunel University
ClinicalTrials.gov Identifier: NCT00789100     History of Changes
Other Study ID Numbers: Nottingham-001
Study First Received: November 10, 2008
Last Updated: November 10, 2008
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
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Heart Diseases
Cardiovascular Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on April 15, 2014