Teen Asthma Control Encouraging a Healthier Lifestyle

Obesity Clinical Trial

— TAC  

Official title:

Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02575326
• Other study ID #: 8298
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: February 2018

Study information

• Verified date: February 2018
• Source: Henry Ford Health System
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Little guidance is given to physicians caring for obese adolescents with asthma, however, findings suggest that interventions designed to achieve asthma control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g., low self-esteem, depression, and low quality of life) successful interventions should incorporate a patient-centered approach. The proposed study design is a clinic-based, randomized controlled trial (RCT) in teens with a history of asthma and who are overweight or obese.

Description:

Asthma that has persisted in adolescents is likely to persist into adulthood. For 25-30% of Americans, adolescence is also the period at which they experience their greatest weight gain, particularly as they approach the final stages of puberty. Asthma management may be more of a challenge in the overweight adolescent compared to a normal weight youth. Asthma related morbidity is increased in overweight patients, reflected in higher health care utilization for this subgroup. Little guidance is given to physicians caring for obese adolescents with asthma, but findings suggest that interventions designated to achieve control in these patients are necessary. Because of the psychosocial factors often associated with obesity and asthma (e.g. low self-esteem, depression and low quality of life) successful interventions should incorporate a patient-centered approach.

Patient-centered care (or patient focused care) involves a partnership between the patient and the physician, shared discussion making, as well as productive communication and health promotion. The objective of this project is to collect the information necessary to develop a tailored discussion guide for use by the physician caring for the obese teen with asthma. Project results will provide an evidence base for the development and evaluation of additional patient-centered health interventions for obese adolescents with asthma. The investigators will conduct this study among patients whom eligibility can be determined using the electronic medical record (EMR). The specific aims of this proposal are to:

Qualitatively collect information on outcomes important to obese adolescents with asthma:

Create a tailored discussion guide that incorporates patient preferences and treatment goals that can be used by providers caring for overweight adolescents with asthma:

Conduct a randomized trial to determine if patient-centered and clinical outcomes improve for patients whose physicians use the tailored discussion guide compared to those who do not.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: February 2018
• Est. primary completion date: February 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 13 Years to 19 Years

Eligibility

Inclusion Criteria:

• BMI >85th Percentile & Diagnosed with asthma; using a modification of Healthcare Effectiveness Data and Information Set (HEDIS) criteria:

• At least one emergency department visit with a principal diagnosis of asthma, or

• At least one acute inpatient claim/encounter with asthma as the principal diagnosis or at least four outpatient visits with an asthma diagnosis and at least or

• At least four asthma four outpatient visit with an asthma diagnosis and at least two asthma medications dispensed, or

• At least four asthma medications dispensed in the last 12 month

Exclusion Criteria:

• Does not meet eligibility criteria for weight and/or asthma;

• Currently enrolled in another investigational asthma management /education/weight management trial.

Related Conditions & MeSH terms

• Asthma
• Obesity

Intervention

Other:
• Standard Control
Teens in the control group will receive standard or usual care as provided by their physician.

Behavioral:
• a provider administered, tailored discussion guide
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.

Locations

Country	Name	City	State
United States	Henry Ford System	Detroit	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
Henry Ford Health System

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Asthma Control Test	A validated measure of asthma control	12 months of enrollment
Secondary	Body Mass Index (BMI)	changes in participant weight	12 months of enrollment