Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Primary Purpose
Chronic Obstructive Pulmonary Disease, Health Status
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Intervention pulmonary nurse
Sponsored by
About this trial
This is an interventional supportive care trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, Health Status, Intervention, Secondary prevention, patient-tailored treatment
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of COPD
- Written informed consent
Exclusion Criteria:
- 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
Sites / Locations
- Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention pulmonary nurse
Usual care
Arm Description
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.
group II: usual care as delivered by the outpatient clinic.
Outcomes
Primary Outcome Measures
Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI
Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue
Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social
Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation
The number of additional treatments
Secondary Outcome Measures
Smoking status
Patient satisfaction with treatment
Sociodemographic variables (i.e. sex, age, education, personal situation, work situation)
Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization)
Accuracy of diagnostic properties of the PatientProfileChart
Full Information
NCT ID
NCT00940355
First Posted
July 15, 2009
Last Updated
January 19, 2010
Sponsor
Radboud University Medical Center
Collaborators
PICASSO: Partners in Care Solutions for COPD
1. Study Identification
Unique Protocol Identification Number
NCT00940355
Brief Title
Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
Secondary Prevention of Problems in Health Status in Patients With COPD by Early Detection, Motivational Intervention to Engage in Treatment by the Patient, and by Individualized Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
July 2009
Overall Recruitment Status
Completed
Study Start Date
September 2007 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
October 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Radboud University Medical Center
Collaborators
PICASSO: Partners in Care Solutions for COPD
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Chronic Obstructive Pulmonary Disease (COPD) is a disease state characterized by airflow that is not fully reversible. Besides problems in physiological functioning, the patient also can experience symptoms, functional impairment and a diminished quality of life (see Vercoulen et al., 2008). Problems in the three latter domains of health status are hardly recognized in usual care, and remain untreated until escalated. This is mainly caused by two phenomena: doctor delay and patient delay. Doctor delay: the physician does not directly identify symptoms, functional impairment, and problems in quality of life. Patient delay: the patient does not report problems in these health status domains.
What is necessary is a screening instrument that can be used in routine care and identifies patients with problems in the four domains of health status. If clinically relevant problems exists, and additional treatment is recommended, an intervention by the pulmonary nurse is indicated. This intervention is directed at increasing awareness of existing problems and motivating the patient for additional treatment. By means of the screening and intervention, problems in health status are detected and treated early, before escalation. Treatment is patient-tailored, based on the existing problems in the four domains of health status, eventually leading to an improved health status.
A randomized controlled trial is conducted to test the hypothesis described above. Based on the independent clinical interpretation of the PatientProfileChart (see Peters et al., 2009) by three professionals, patients are assigned to one of the following groups: 1. Patients with no clinically relevant problems in health status (group I), and 2. Patients with clinically relevant problems in health status (group II/III). Patients with clinically relevant problems in health status are randomized to a control group (group II: usual care as delivered by the outpatient clinic) and the experimental group (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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease, Health Status
Keywords
COPD, Health Status, Intervention, Secondary prevention, patient-tailored treatment
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
303 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention pulmonary nurse
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
group II: usual care as delivered by the outpatient clinic.
Intervention Type
Behavioral
Intervention Name(s)
Intervention pulmonary nurse
Intervention Description
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.
Primary Outcome Measure Information:
Title
Physiological Functioning: TLC% predicted, RV% predicted, FEV1% predicted, BMI
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Symptoms: Physical Activity Rating Scale Dyspnoea- Global Dyspnoea Activity and Global Dyspnoea Burden, Dyspnoea Emotions Questionnaire - Frustration and Anxiety, Checklist Individual Strength - Fatigue
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Quality of Life: Beck Depression Inventory Primary Care, Satisfaction with Life Scale, Satisfaction Physical, Satisfaction Future, Satisfaction Spouse and Satisfaction Social
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Functional Impairment: Quality of Life for Respiratory Illness Questionnaire - General Activities, Sickness Impact Profile - Home Management and Ambulation
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
The number of additional treatments
Time Frame
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 Outcome Measure Information:
Title
Smoking status
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Patient satisfaction with treatment
Time Frame
T1 (after 6 months) T2 (after 12 months). T1: group II/III T2 group I/II/III
Title
Sociodemographic variables (i.e. sex, age, education, personal situation, work situation)
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Clinical variables (i.e. comorbidity, previous and current treatments, hospitalization)
Time Frame
T0 (baseline), T1 (after 6 months) T2 (after 12 months). T0: group I/II/III T1: group II/III T2 group I/II/III
Title
Accuracy of diagnostic properties of the PatientProfileChart
Time Frame
T0 (baseline), T0: group I/II/III
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of COPD
Written informed consent
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonie Daudey, MSc.
Organizational Affiliation
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jan Vercoulen, Dr.
Organizational Affiliation
Radboud University Nijmegen Medical Center, department of Medical Psychology & department of Pulmonary Diseases
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Jan Vercoulen, Dr.
Organizational Affiliation
Radboud University NIjmegen Medical Center, Department of Medical Psychology & department of Pulmonary Diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Radboud University Nijmegen Medical Center, department of Pulmonary Diseases
City
Groesbeek
ZIP/Postal Code
6560 AB
Country
Netherlands
12. IPD Sharing Statement
Citations:
PubMed Identifier
19005926
Citation
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.
Results Reference
background
PubMed Identifier
19543807
Citation
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.
Results Reference
background
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Secondary Prevention of Problems in Health Status in Patients With Chronic Obstructive Pulmonary Disease (COPD)
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