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Clinical Trials/NCT02413684
NCT02413684
Completed
Not Applicable

Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma

Duke University1 site in 1 country53 target enrollmentAugust 2015
ConditionsAsthma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Asthma
Sponsor
Duke University
Enrollment
53
Locations
1
Primary Endpoint
Rate of Asthma Exacerbations
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.

Detailed Description

Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective. The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions. Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
September 2016
Last Updated
7 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Patients with a physician diagnosis of asthma for at least the previous 12 months.
  • Asthma that is not well controlled by NAEPP guidelines.
  • Ability and willingness to provide informed consent

Exclusion Criteria

  • Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
  • Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
  • A diagnosis of cancer with ongoing treatment.
  • Any terminal illness or conditions that results in a life expectancy less than one year.

Outcomes

Primary Outcomes

Rate of Asthma Exacerbations

Time Frame: baseline to week 13

The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13

Secondary Outcomes

  • Change in Asthma Control(baseline, 13 weeks)
  • Change in Pulmonary Function Tests(baseline, 13 weeks)
  • Number of Emergency Department and Hospitalization Visits(13 weeks)
  • Change in Asthma Symptoms(baseline, 13 weeks)

Study Sites (1)

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