Clinical trial NCT02413684: PackHealth: Asthma Engagement Tool
Official title: Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-04-10
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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

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.

Primary outcomes:
measure: Rate of Asthma Exacerbations
timeFrame: 12 weeks prior to baseline
measure: Rate of Asthma Exacerbations
timeFrame: baseline to week 13
Secondary outcomes:
measure: Change in Asthma Control
timeFrame: baseline, 13 weeks
measure: Change in Asthma Symptoms
timeFrame: baseline, 13 weeks
measure: Change in Pulmonary Function Tests
timeFrame: baseline, 13 weeks
measure: Number of Emergency Department and Hospitalization Visits
timeFrame: Prior Year
measure: Number of Emergency Department and Hospitalization Visits
timeFrame: 13 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Asthma Allergy and Airway Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Njira Lugogo, MD
role: PRINCIPAL_INVESTIGATOR
References: