Integrated Care Program for Chronic Obstructive Pulmonary Disease

NCT01045213 | Completed Phase 3

• 2 other identifiers: 08-058809 FLA 000317
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic obstructive pulmonary disease; COPD

Outcome Measures

Primary Outcomes (1)

• Quality of Life measured by the St. Georges Respiratory Questionnaire

  3 months

Secondary Outcomes (7)

• Guideline-based medical care

  3 months

• Oxygen utilization and pre/post exercise oxygen saturations

  3 months

• Smoking status

  3 months

• Exercise status measured by the 6 minute walk test

  3 months

• Symptoms including cough, sputum production and dyspnea (measured by the modified Medical Research Council (MMRC) dyspnea scale)

  3 months

Study Arms (1)

Proactive Integrated Care

EXPERIMENTAL

COPD education, self-management education, remote monitoring (Health Buddy, pulse oximeter, pedometer, spirometer) and enhance communication with cell phone contact with a coordinator.

Other: Integrated Care

Interventions

Integrated Care OTHER

Study looking at the efficacy of a combination of Guideline-based COPD education, self-management training, remote telemonitoring and enhanced communication with a coordinator.

Proactive Integrated Care

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Delivery of Health Care, Integrated

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Delivery of Health Care; Patient Care Management; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• William Vandivier, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2010
• First Posted: January 8, 2010
• Study Start: October 1, 2008
• Primary Completion: March 1, 2009
• Study Completion: June 1, 2009
• Last Updated: October 5, 2012

Record last verified: 2012-10

Locations

US (1)