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Completed

NCT Number: NCT02413684

PackHealth: Asthma Engagement Tool

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Asthma Allergy and Airway Center

Durham, North Carolina, 27705, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Rate of Asthma Exacerbations

    Time frame: 12 weeks prior to baseline

    The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.

  2. 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

  1. Change in Asthma Control

    Time frame: baseline, 13 weeks

    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.

  2. Change in Asthma Symptoms

    Time frame: baseline, 13 weeks

    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

  3. Change in Pulmonary Function Tests

    Time frame: baseline, 13 weeks

    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.

  4. Number of Emergency Department and Hospitalization Visits

    Time frame: Prior Year

    Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.

  5. Number of Emergency Department and Hospitalization Visits

    Time frame: 13 weeks

    Number of emergency department and hospitalization visits will be recorded

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 10, 2015
Registry last updated
Oct 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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