NCT00411346

Brief Summary

The objective of this study was to investigate if a nurse-led telemonitoring programme is effective and cost-effective in asthmatic outpatients, aged seven years and older.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Jan 2003

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

Study Start

First participant enrolled

January 1, 2003

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2004

Completed
2.1 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 14, 2006

Completed
Last Updated

December 14, 2006

Status Verified

December 1, 2006

First QC Date

December 13, 2006

Last Update Submit

December 13, 2006

Conditions

Asthma

Keywords

AsthmaSelf-MonitoringCost-effectiveness

Outcome Measures

Primary Outcomes (1)

  • Asthma-specific quality of life at one year.

Secondary Outcomes (4)

  • Asthma symptoms at one year

  • generic quality of life at one year

  • direct and indirect costs during one year

  • satisfaction with and feasibility of the intervention at one year.

Interventions

Nurse-led telemonitoringPROCEDURE

Eligibility Criteria

Age7 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • Asthma severity of stage I - III as described in the GINA guidelines
  • Must be competent to use an asthma monitor
  • Must possess a household phone connection

You may not qualify if:

  • Respiratory co-morbidity

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Maastricht

Maastricht, Limburg, 6202 AZ, Netherlands

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Emiel FM Wouters, MD PhD

    Department of Respiratory Medicine

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 13, 2006

First Posted

December 14, 2006

Study Start

January 1, 2003

Study Completion

November 1, 2004

Last Updated

December 14, 2006

Record last verified: 2006-12

Locations

NL(1)