NCT00189852

Brief Summary

The primary objective of this project is to investigate whether, in a pilot randomised controlled trial, the use of telecare (remote monitoring) technologies reduces the frequency of hospital admissions for people with chronic heart failure (CHF) and to inform the design of a larger randomised controlled trial of telecare for CHF. Secondary objectives are:

  1. 1.To investigate whether there are benefits to users
  2. 2.To understand the impact on carers in terms of carer stress
  3. 3.To investigate whether there are benefits to the NHS and other statutory provisions
  4. 4.To investigate which users receive the greatest benefits
  5. 5.To inform whether remote monitoring of CHF patients should be provided as part of hospital discharge for a set period of time or whether it should be provided long term and be used in a preventative manner
  6. 6.To investigate whether CHF episodes can be detected and predicted based on lifestyle changes
  7. 7.To determine whether lifestyle monitoring equipment can be correlated with the information from the CHF monitoring system to determine the potential to detect deteriorating health.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P25-P50 for not_applicable heart-failure

Timeline
Completed

Started Nov 2005

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 13, 2005

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2005

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2009

Completed
Last Updated

February 19, 2016

Status Verified

February 1, 2016

Enrollment Period

1.8 years

First QC Date

September 13, 2005

Last Update Submit

February 18, 2016

Conditions

Heart Failure

Keywords

Telecarechronicolder peopleheart failure

Outcome Measures

Primary Outcomes (1)

  • Different number of hospital admissions between groups

Secondary Outcomes (2)

  • Benefits to users

  • Impact on carers

Study Arms (2)

Docobo

EXPERIMENTAL

telemonitoring at home system for heart failure

Device: Chronic heart failure monitoring systemDevice: Lifestyle monitoring system

Control

NO INTERVENTION

No telemonitoring system in place

Interventions

Chronic heart failure monitoring systemDEVICE
Docobo
Lifestyle monitoring systemDEVICE
Docobo

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Participants identified as having chronic heart failure
  • Over the age of 60
  • New York Heart Association (NYHA) functional classification 2, 3, or 4.

You may not qualify if:

  • Ejection fraction more than 40%
  • Under the age of 60
  • Class 1 as determined by the NYHA

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Barnsley Hospital NHS Foundation Trust

Barnsley, Yorkshire, S75 2EP, United Kingdom

Location

MeSH Terms

Conditions

Heart FailureBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Mark Hawley

    Barnsley Hospital NHS Foundation Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 19, 2005

Study Start

November 1, 2005

Primary Completion

September 1, 2007

Study Completion

February 1, 2009

Last Updated

February 19, 2016

Record last verified: 2016-02

Locations

GB(1)