Evaluation of Remote Patient Monitoring.

NCT ID: NCT00789100

Last Updated: 2014-07-17

Basic Information

• Recruitment Status: WITHDRAWN
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-02-28

Brief Summary

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.

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.

Conditions

Congestive Heart Failure; Chronic Obstructive Pulmonary Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

1

Group provided with home-based monitor

No interventions assigned to this group

2

Group receives no home-based monitor

No interventions assigned to this group

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nottingham City Primary Care Trust

UNKNOWN

Sponsor Role: collaborator

Brunel University

OTHER

Sponsor Role: lead

Responsible Party

Malcolm Clarke

Reader

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Malcolm Clarke, PhD

Role: PRINCIPAL_INVESTIGATOR

Brunel University

Locations

Nottingham PCT

Nottingham, Nottinghamshire, United Kingdom

Countries

United Kingdom

Other Identifiers

Nottingham-001

Identifier Type: -

Identifier Source: org_study_id