PackHealth: Asthma Engagement Tool

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02413684
• Other study ID #: Pro00057939
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: September 2016

Study information

• Verified date: December 2017
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: September 2016
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Asthma

Intervention

Behavioral:
• Patient engagement toolkit
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

Locations

Country	Name	City	State
United States	Duke Asthma Allergy and Airway Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Asthma Exacerbations	The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.	12 weeks prior to baseline
Primary	Rate of Asthma Exacerbations	The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13	baseline to week 13
Secondary	Change in Asthma Control	Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control.	baseline, 13 weeks
Secondary	Change in Asthma Symptoms	Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall.; Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09	baseline, 13 weeks
Secondary	Change in Pulmonary Function Tests	Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline.	baseline, 13 weeks
Secondary	Number of Emergency Department and Hospitalization Visits	Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.	Prior Year
Secondary	Number of Emergency Department and Hospitalization Visits	Number of emergency department and hospitalization visits will be recorded	13 weeks