Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)

Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Asthma
• Intervention / Treatment: Other: Standard Control; Behavioral: a provider administered, tailored discussion guide

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford System

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard Control; Teens in the control group will receive standard or usual care as provided by their physician.	Other: Standard Control; Teens in the control group will receive standard or usual care as provided by their physician.
Other: Intervention; Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Asthma Control Test	A validated measure of asthma control	12 months of enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body Mass Index (BMI)	changes in participant weight	12 months of enrollment

Collaborators and Investigators

• Sponsor: Henry Ford Health System
• Investigators: Principal Investigator: Christine Joseph, PhD, Henry Ford Health System

Publications and helpful links

General Publications

• Joseph CLM, Alexander GL, Lu M, Leatherwood SL, Kado R, Olden H, Melkonian C, Miree CA, Johnson CC. Pilot study of a brief provider and EMR-based intervention for overweight teens with asthma. Pilot Feasibility Stud. 2021 Aug 30;7(1):167. doi: 10.1186/s40814-021-00848-6.

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): February 1, 2018
• Study Completion (Actual): February 1, 2018

Study Registration Dates

• First Submitted: October 12, 2015
• First Submitted That Met QC Criteria: October 13, 2015
• First Posted (Estimate): October 14, 2015

Study Record Updates

• Last Update Posted (Actual): August 6, 2018
• Last Update Submitted That Met QC Criteria: August 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Asthma, Body Mass Idex, BMI, Overweight, Obesity
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 8298 (CTEP)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided