ClinicalTrials.gg
Status unknownNCT01921556CAROLUpdated Jun 20, 2016

The Improving Care in Chronic Obstructive Lung Disease Study A Cluster Randomized Trial

An interventional study of active comparator, QualiCCare education in COPD, sponsored by University of Zurich. Status unknown at 1 site in Switzerland. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2016-06-20.

Sponsored by University of Zurich · Not applicable, Interventional, and Health services research

The sponsor has not verified this record recently (last verified Jun 2016), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
216
Allocation
Randomized
Ages
45 Years to 85 Years
Sex
All
01

Study summary

Background The Swiss health ministry launched a national quality program "QualiCCare" in 2011 to improve healthcare for patients with COPD.

The aim of this study is to determine whether participation in the COPD quality initiative ("QualiCCare") improves adherence to recommended clinical processes and shows impact on patients COPD care and on quality of life in patients with COPD.

Read the detailed description

The care in obstructive lung disease study (CAROL) is a cluster-randomized controlled trial with randomization on the practice level. Thirty practices will be randomly assigned to equally sized intervention group or control group.

Each General Practioner (GP) of a practice will approach consecutively and regardless the reason for the current encounter, COPD patients diagnosed by spirometric evaluation (FEV1/ FVC \< 0.70), aged 45 years older, with a smoking history of = 10 pack-years (PY). GPs in the intervention group will receive "QualiCCare" education, which addresses knowledge, decision-making and behavioural aspects as well as delivery of care according to COPD quality indicators and evidence based key elements. In the control group no educational intervention will be applied and COPD patients will be treated as usual. The study period is one year.

The primary outcome measure is an aggregated score of relevant clinical processes defining elements in the care of patients with COPD: smoking cessation counseling, influenza vaccination, motivation for physical activity, appropriate pharmacotherapy, patient education and collaborative care.

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Conditions studied

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In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 216 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

University of Zurich is the lead sponsor of 1,048 studies on the registry; 132 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
45 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Males and females = 45yrs of age and
  • Smoker or ex-smoker (with at least 10 PY) and
  • Obstruction in spirometry FEV1/FVC\< 0.7

Exclusion criteria

Exclusion criteria:

  • No obstruction in spirometry (FEV1/FVC > 0.7) or
  • Patients with history of asthma or hay fever or
  • Other concomitant pulmonary disease or
  • Patients with malignancies of any other system and/or other severe disease with an estimated life expectancy of less than six months or
  • Insufficient German language skills or
  • Patients who contact the practice for emergencies only or as a substitute practice
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Study design

Phase
Not applicable
Primary purpose
Health services research
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
216 participants (estimated)

Study arms

  • Active comparator
    QualiCCare education

    "QualiCCare"education is a training workshop designed to educate professionals on the guidelines but also and particularly governing professional behavior by feedback, reminders and pathways that help to change their attitudes and care behavior. Based on behavioral and learning theory, QualiCCare intervention not only tries to increase knowledge but also internal motivation and decision making by stimuli and resources and by written instruments that guide evidence based decision support.

    Behavioral: active comparator, QualiCCare education

  • No intervention
    usual care

    The practices randomized to the control group apply care as usual

Interventions

  • Behavioralactive comparator, QualiCCare education

    Physicians randomized into the intervention group get a "QualiCCare" training workshop designed to educate professionals on the guidelines but also and particularly governing professional behavior by feedback, reminders and pathways that help to change their attitudes and care behavior. Based on behavioral and learning theory, QualiCCare intervention not only tries to increase knowledge but also internal motivation and decision making by stimuli and resources and by written instruments that guide evidence based decision support.

06

What researchers measure

Primary outcomes

  1. "Quality of care process"

    Difference in "quality of care process" (total increase in performed measures/fulfilled indicators) will be assessed after one year between COPD patients in the intervention and control group as reported by the patient

    Time frame: one year

Secondary outcomes

  1. Quality of life

    We use the COPD Assessment Test (CAT). The CAT provides clinicians and patients with a reliable measure of overall COPD-related health status for the assessment and long-term follow-up of individual patients. The CAT is a validated short and simple patient-completed questionnaire that has been developed for use in routine clinical practice to measure the health status and grading the impact of COPD on patients' life. The CAT has very similar discriminative properties to the much more complex SGRQ (St. Georges Respiratory Questionnaire), and is available in different languages. It compromises 8 simple questions, 8 items on a scale 0-5 with a total scoring range of 0-40. CAT score \<10 low impact, 10-20 medium impact \>30 very high impact of COPD on patients life

    Time frame: one year

07

Study locations

1 site
  • Institute of General Practice, University of Zurich
    Zurich, 8091, Switzerland
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References and documents

Publications

  • Steurer-Stey C, Markun S, Lana KD, Frei A, Held U, Wensing M, Rosemann T. The improving care in chronic obstructive lung disease study: CAROL improving processes of care and quality of life of COPD patients in primary care: study protocol for a randomized controlled trial. Trials. 2014 Mar 27;15:96. doi: 10.1186/1745-6215-15-96. PubMed 24670200 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 20, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01921556
Responsible party
Sponsor
First posted
Aug 13, 2013
Start date
Sep 2013
Primary completion
Jan 2017 (estimated)
Completion
Oct 2017 (estimated)
Last update
Jun 20, 2016

Study contacts

Thomas J. Rosemann, Prof MD
principal investigator · University Hospital Zurich, Institute of General Practice

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2016. You cannot join it, but the record below documents what was studied.

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