Clinical trial NCT01045213: Integrated Care Program for Chronic Obstructive Pulmonary Disease
Official title: Phase 3 Study of the Efficacy of Proactive Integrated Care in Advanced COPD Patients Located in Areas With High COPD-related Mortality
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic obstructive pulmonary disease
COPD
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
First posted: 2010-01-08
Enrollment: 100
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Integrated eHealth is an innovative, proactive approach to the management of patients with chronic cardiopulmonary disease. Our overall goal is to improve the health of patients by integrating guideline-based education, remote disease monitoring, coordinator-based disease management and healthcare provider-initiated therapy. Patients enrolled in the program receive a set of equipment, including a Health Buddy® telemonitor that connects to a normal telephone, as well as instruments to measure oxygen levels (pulse oximeter), lung function (spirometer) and activity (pedometer). Through the Health Buddy® patients receive guideline-based disease education in their own homes. The Health Buddy® also allows patients to transmit daily information about their symptoms, oxygen levels, lung function and ability to walk to program coordinators located at the University of Colorado Hospital. Our program coordinators are highly experienced nurses or respiratory therapists with expertise in the management of chronic obstructive pulmonary disease (COPD) and congestive heart failure (CHF). Through this remote disease education/monitoring program, patients learn to take a more active role in the management of their own disease. However, once the coordinators identify early warning signs of a potential problem, patients are contacted and connected to their primary healthcare provider for early intervention. By this integrated approach to care, patients learn self-management techniques, physician communication is enhanced, and early interventions for problems are possible. We propose to target the Integrated eHealth Program to areas of Colorado that are highly impacted by COPD.

Key Objectives: The key objectives are to improve COPD care in the 16 Colorado counties with high COPD mortality rates.

Target Population: We will target patients with severe or very severe COPD.

Expected Outcomes: We expect that this study will increase the use of evidence-based guidelines in the screening, diagnosis and treatment of COPD, resulting in improved quality-of-life and a reduction in healthcare utilization.


Eligibility criteria: Inclusion Criteria:

* COPD Diagnosis by Gold Guidelines
* Airflow obstruction on spirometry defined by an FEV1/FVC less than or equal to 70% and an FEV1 less than 50% predicted, or and FEV1 greater than or equal to 50% predicted with a history of a COPD exacerbation within one year, or an FEV1 greater than or equal to 50% predicted and on long-term oxygen therapy.
* Standard land-line telephone
* Legal US residency status residing in Adams, Alamosa, Bent, Crowley, Dolores, El Paso, Fremont, Kiowa, Logan, Morgan, Montezuma, Otero, Prowers, Rio Blanco, or Washington counties in Colorado

Exclusion Criteria:

* Asthma
* Co-existing conditions that are likely to cause death within two years. Patients with CXR evidence of interstitial lung disease, or other pulmonary diagnoses at the time of enrollment, aside from COPD-related bronchiectasis. Patients with end-stage liver, renal or muscle disease, HIV, or a diagnosis of dementia.
* Participation in another treatment study
* Inability or unwillingness to cooperate with self-monitoring and reporting components
* Prisoners, pregnant women, institutionalized patients
* Current alcohol or drug abuse
* Non-English speakers
* Inability to complete a consent
* Illegal alien, non-Colorado resident, or non-resident of targeted counties

Primary outcomes:
measure: Quality of Life measured by the St. Georges Respiratory Questionnaire
timeFrame: 3 months
Secondary outcomes:
measure: Guideline-based medical care
timeFrame: 3 months
measure: Oxygen utilization and pre/post exercise oxygen saturations
timeFrame: 3 months
measure: Smoking status
timeFrame: 3 months
measure: Exercise status measured by the 6 minute walk test
timeFrame: 3 months
measure: Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)
timeFrame: 3 months
measure: Body Mass Index, Obstruction, Dyspnoea, Exercise Capacity (BODE) Index
timeFrame: 3 months
measure: Healthcare utilization
timeFrame: 3 months
Other outcomes:
Locations:
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
Study officials:
affiliation: University of Colorado, Denver
name: William Vandivier, MD
role: PRINCIPAL_INVESTIGATOR
References: