Teen Asthma Control Encouraging a Healthier Lifestyle

NCT ID: NCT02575326

Last Updated: 2018-08-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2018-02-28

Brief 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.

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.

Conditions

Asthma; Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Standard Control

Teens in the control group will receive standard or usual care as provided by their physician.

Group Type: OTHER

Standard Control

Intervention Type: OTHER

Teens in the control group will receive standard or usual care as provided by their physician.

Intervention

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

Group Type: OTHER

a provider administered, tailored discussion guide

Intervention Type: BEHAVIORAL

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

Interventions

Standard Control

Teens in the control group will receive standard or usual care as provided by their physician.

Intervention Type: OTHER

a provider administered, tailored discussion guide

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Henry Ford Health System

OTHER

Sponsor Role: lead

Responsible Party

Christine Joseph

Senior Epidemiologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christine Joseph, PhD

Role: PRINCIPAL_INVESTIGATOR

Henry Ford Health System

Locations

Henry Ford System

Detroit, Michigan, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34462008 (View on PubMed)

Other Identifiers

8298

Identifier Type: -

Identifier Source: org_study_id