PackHealth: Asthma Engagement Tool

NCT ID: NCT02413684

Last Updated: 2018-10-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2016-09-30

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

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Asthma Patients

Patient engagement toolkit

Group Type: OTHER

Patient engagement toolkit

Intervention Type: 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

Interventions

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

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Njira Lugogo, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Duke Asthma Allergy and Airway Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

Pro00057939

Identifier Type: -

Identifier Source: org_study_id