PackHealth: Asthma Engagement Tool

NCT02413684 | Completed Results

• 1 other identifier: Pro00057939
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (5)

• Change in Asthma Control

  baseline, 13 weeks

• Change in Asthma Symptoms

  baseline, 13 weeks

• Change in Pulmonary Function Tests

  baseline, 13 weeks

• Number of Emergency Department and Hospitalization Visits

  Prior Year

• Number of Emergency Department and Hospitalization Visits

  13 weeks

Study Arms (1)

Asthma Patients

OTHER

Patient engagement toolkit

Behavioral: Patient engagement toolkit

Interventions

Patient engagement toolkit BEHAVIORAL

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

Asthma Patients

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Results Point of Contact

• Title: Njira Lugogo
• Organization: Duke Asthma, Airway and Allergy Center

njira.lugogo@duke.edu

919-613-5707

Study Officials

• Njira Lugogo, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2015
• First Posted: April 10, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2016
• Last Updated: October 9, 2018
• Results First Posted: October 9, 2018

Record last verified: 2017-12

Locations

US (1)