Teen Asthma Control Encouraging a Healthier Lifestyle (TAC)
Primary Purpose
Asthma, Obesity
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Standard Control
a provider administered, tailored discussion guide
Sponsored by
About this trial
This is an interventional other trial for Asthma focused on measuring Asthma, Body Mass Idex, BMI, Overweight, Obesity
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.
Sites / Locations
- Henry Ford System
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Standard Control
Intervention
Arm Description
Teens in the control group will receive standard or usual care as provided by their physician.
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
Outcomes
Primary Outcome Measures
Asthma Control Test
A validated measure of asthma control
Secondary Outcome Measures
Body Mass Index (BMI)
changes in participant weight
Full Information
NCT ID
NCT02575326
First Posted
October 12, 2015
Last Updated
August 2, 2018
Sponsor
Henry Ford Health System
1. Study Identification
Unique Protocol Identification Number
NCT02575326
Brief Title
Teen Asthma Control Encouraging a Healthier Lifestyle
Acronym
TAC
Official Title
Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
February 2018 (Actual)
Study Completion Date
February 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Henry Ford Health System
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Obesity
Keywords
Asthma, Body Mass Idex, BMI, Overweight, Obesity
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Physicians are randomized. Eligible youth that present to the participating physician assume the assignment of that physician
Allocation
Randomized
Enrollment
44 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard Control
Arm Type
Other
Arm Description
Teens in the control group will receive standard or usual care as provided by their physician.
Arm Title
Intervention
Arm Type
Other
Arm Description
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
Intervention Type
Other
Intervention Name(s)
Standard Control
Intervention Description
Teens in the control group will receive standard or usual care as provided by their physician.
Intervention Type
Behavioral
Intervention Name(s)
a provider administered, tailored discussion guide
Intervention Description
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
Primary Outcome Measure Information:
Title
Asthma Control Test
Description
A validated measure of asthma control
Time Frame
12 months of enrollment
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI)
Description
changes in participant weight
Time Frame
12 months of enrollment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
13 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christine Joseph, PhD
Organizational Affiliation
Henry Ford Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Henry Ford System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
34462008
Citation
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.
Results Reference
derived
Learn more about this trial
Teen Asthma Control Encouraging a Healthier Lifestyle
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