NCT00940355

Brief Summary

The purpose of this study is to determine the effectiveness of an intervention conducted by a pulmonary nurse in patients with COPD. The hypothesis is that in a sample of COPD patients with clinically relevant problems in health status (physiological functioning, symptoms, functional impairment and quality of life), a motivational intervention conducted by a pulmonary nurse will lead to patient-tailored treatment and an improved health status.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
303

participants targeted

Target at P75+ for not_applicable chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2007

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

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

September 1, 2007

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 16, 2009

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
Last Updated

January 20, 2010

Status Verified

July 1, 2009

Enrollment Period

2.1 years

First QC Date

July 15, 2009

Last Update Submit

January 19, 2010

Conditions

Chronic Obstructive Pulmonary DiseaseHealth Status

Keywords

COPDHealth StatusInterventionSecondary preventionpatient-tailored treatment

Outcome Measures

Primary Outcomes (5)

  • Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • The number of additional treatments

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

Secondary Outcomes (5)

  • Smoking status

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Patient satisfaction with treatment

    T1 (after 6 months) T2 (after 12 months). T1: group II/III T2 group I/II/III

  • Sociodemographic variables (i.e. sex, age, education, personal situation, work situation)

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization)

    T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III

  • Accuracy of diagnostic properties of the PatientProfileChart

    T0 (baseline), T0: group I/II/III

Study Arms (2)

Intervention pulmonary nurse

EXPERIMENTAL

group III: intervention conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, increasing motivation to engage in additional treatment, and improving health status.

Behavioral: Intervention pulmonary nurse

Usual care

NO INTERVENTION

group II: usual care as delivered by the outpatient clinic.

Interventions

Intervention pulmonary nurseBEHAVIORAL

The intervention is conducted by a pulmonary nurse, directed at increasing awareness of problems in health status, and increasing motivation to engage in additional treatment, and improving health status.

Intervention pulmonary nurse

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of COPD
  • Written informed consent

You may not qualify if:

  • Not able to adhere to study protocol
  • Not competent enough in understanding Dutch language
  • Participation in pulmonary rehabilitation program within previous 6 months
  • Current participation in other research study in COPD

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Nijmegen Medical Center, department of Pulmonary Diseases

Groesbeek, 6560 AB, Netherlands

Location

Related Publications (2)

  • Vercoulen JH, Daudey L, Molema J, Vos PJ, Peters JB, Top M, Folgering H. An Integral assessment framework of health status in chronic obstructive pulmonary disease (COPD). Int J Behav Med. 2008;15(4):263-79. doi: 10.1080/10705500802365474.

    PMID: 19005926BACKGROUND

  • Peters JB, Daudey L, Heijdra YF, Molema J, Dekhuijzen PN, Vercoulen JH. Development of a battery of instruments for detailed measurement of health status in patients with COPD in routine care: the Nijmegen Clinical Screening Instrument. Qual Life Res. 2009 Sep;18(7):901-12. doi: 10.1007/s11136-009-9502-2. Epub 2009 Jun 19.

    PMID: 19543807BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Leonie Daudey, MSc.

    Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases

    PRINCIPAL INVESTIGATOR

  • Jan Vercoulen, Dr.

    Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases

    STUDY DIRECTOR

  • Jan Vercoulen, Dr.

    Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases

    STUDY CHAIR

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

July 15, 2009

First Posted

July 16, 2009

Study Start

September 1, 2007

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

January 20, 2010

Record last verified: 2009-07

Locations

NL(1)