Enhancing Collaboration Between Doctors and Patients to Improve Asthma

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT00201188
First received: September 16, 2005
Last updated: March 7, 2013
Last verified: March 2013
  Purpose

The purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by using reports of peak flow monitoring to prompt communication between patients and their doctors.


Condition Intervention
Asthma
Lung Diseases
Behavioral: Status Reports

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cueing Patient-Clinician Collaboration to Improve Asthma

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • Adherence to ICS medication [ Time Frame: Measured on a monthly basis ] [ Designated as safety issue: No ]

Enrollment: 139
Study Start Date: December 2003
Study Completion Date: February 2008
Primary Completion Date: February 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Participants will receive feedback and peak flow monitoring reports from their doctors.
Behavioral: Status Reports
Interpreted Analysis of Peak-Flow Monitoring Trends
No Intervention: 2
Participants will receive usual care.

Detailed Description:

BACKGROUND:

Asthma is a chronic, potentially life-threatening disease that affects 17 million people in the United States. Asthma leads to millions of lost work days and thousands of hospitalizations annually. For the millions of people with this disease, it is chronic but controllable. Corticosteroids are the most effective medication for the long-term treatment of persistent asthma, and inhaling the medication minimizes the potential for systemic side effects. Despite convincing evidence of the benefits of inhaled corticosteroids (ICS), both patients and doctors seem reluctant to use them regularly. Many people who are prescribed ICS either never take them, or take them less frequently (e.g., once rather than twice daily), less regularly (e.g., "as needed" rather than daily), or at lower doses than prescribed. Doctors agree that at least 50% of people who are prescribed ICS fail to benefit fully because of poor adherence. The many reasons for non-adherence are not fully understood. The relationship between the doctor and patient, an area in which potential impact can be made, is believed to be the strongest predictor of medication adherence. Providing pertinent information about asthma related lung function should prompt communication between the patient and doctor to improve adherence to ICS.

DESIGN NARRATIVE:

The overall purpose of this study is to improve anti-inflammatory medication adherence and asthma outcomes by encouraging communication between patients and their doctor. The specific aims of the study include the following: 1) improve adherence to ICS medication by encouraging patient-doctor communication with feedback of objective information about airflow obstruction to reinforce medication-taking behavior; and 2) document the impact that the encouragement of communication has on health care outcomes, including health care utilization, pulmonary function, need for rescue courses of oral steroids, and functional impact. The hypothesis of the study is that informing patients and their primary care doctors about the degree of airflow obstruction will prompt interaction between them resulting in greater adherence to ICS medication over one year than will occur in a control group of similar patients who do not receive feedback. Promoting communication between adults with asthma and their doctors in a primary care clinical setting has not yet been studied. All doctors within three general medicine practices and their adult patients with moderate to severe asthma will be enrolled and assigned to either the intervention or usual care. Feedback of interpreted peak flow graphs in relation to current medication therapy will prompt the communication. The intent is to encourage and support the relationship between the doctor and patient rather than to directly intervene. The power of encouraging communication lies in the ensuing dialogue between the doctor and patient. Improvement of adherence to ICS among people with moderate or severe asthma has been shown to decrease morbidity of asthma and improve health outcomes.

  Eligibility

Ages Eligible for Study:   18 Years to 72 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Asthma
  • Currently using ICS
  • Planning to live in the San Francisco Bay Area in the year following study entry

Exclusion Criteria:

  • Diagnosis of any lung disease other than asthma
  • Has a smoking history greater than or equal to 15 pack-years
  • Psychological problems that may make monthly study visits impossible
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201188

Locations
United States, California
University of California, San Francisco, Parnassus Campus
San Francisco, California, United States, 94143
Sponsors and Collaborators
University of California, San Francisco
Investigators
Study Chair: Susan L. Janson, DNSc,ANP,RN University of California, San Francisco
  More Information

No publications provided by University of California, San Francisco

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00201188     History of Changes
Other Study ID Numbers: 279, R01HL073098, R01 HL73098
Study First Received: September 16, 2005
Last Updated: March 7, 2013
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Asthma
Lung Diseases
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 11, 2014