AsthmaTACNCT02575326
Teen Asthma Control Encouraging a Healthier Lifestyle
A study testing a provider administered, tailored discussion guide in people with Asthma and Obesity, run by Henry Ford Health System at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 13 to 19 yearsHealthy volunteers can take part
- What is being tested?
- a provider administered, tailored discussion guide
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 19 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- Does not meet eligibility criteria for weight and/or asthma;
- Currently enrolled in another investigational asthma management /education/weight management trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- Standard Control, a provider administered, tailored discussion guide
- Keywords
- Asthma, Body Mass Idex, BMI, Overweight, Obesity
- Medical subject headings
- Asthma, Obesity, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard ControlOther
Teens in the control group will receive standard or usual care as provided by their physician.
a provider administered, tailored discussion guideBehavioural
Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques.
| Study group | Role | What they receive |
|---|---|---|
| Standard Control | Other | Teens in the control group will receive standard or usual care as provided by their physician. Receives: Other: Standard Control |
| Intervention | Other | Teens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques. Receives: Behavioral: a provider administered, tailored discussion guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma Control Test
A validated measure of asthma control
Measured: 12 months of enrollment
Secondary outcomes (1)
Body Mass Index (BMI)
changes in participant weight
Measured: 12 months of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2015 (estimated)
- Study startAug 2015
- Primary completionFeb 2018
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Henry Ford Health SystemThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Henry Ford Health System
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Joseph, Henry Ford Health System
- Investigators
- Christine Joseph, PhD, Principal investigator, Henry Ford Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02575326
- Sponsor's protocol ID
- 8298
- Acronym
- TAC
- Status last verified
- Feb 2018
- First submitted
- 12 Oct 2015
- Last updated
- 6 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 34462008
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Patient-Centered Approaches to Asthma Management in Obese Adolescents
- ClinicalTrials.gov ID
- NCT02575326
- Acronym / sponsor ID
- TAC / 8298
- Keywords
- Asthma, Body Mass Idex, BMI, Overweight, Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Henry Ford Health SystemUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Feb 2018 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 14 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Control | Other | Other: Standard ControlTeens in the control group will receive standard or usual care as provided by their physician. |
| Intervention | Other | Behavioral: a provider administered, tailored discussion guideTeens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques. |
Who may qualify
- Ages
- 13 to 19 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Does not meet eligibility criteria for weight and/or asthma;
- Currently enrolled in another investigational asthma management /education/weight management trial.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard ControlTeens in the control group will receive standard or usual care as provided by their physician. | Other | Standard Control |
| a provider administered, tailored discussion guideTeens in the intervention group will receive a provider administered, tailored discussion guide based on motivational interviewing techniques. | Behavioural | Intervention |
Primary outcome
Asthma Control Test
Time frame: 12 months of enrollment
A validated measure of asthma control
1 secondary outcome
Body Mass Index (BMI)
Time frame: 12 months of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2018.
- Derived from this study: PubMed 34462008Joseph 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Joseph, PhD principal investigator
Henry Ford Health System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing a provider administered, tailored discussion guide in people with Asthma and Obesity, run by Henry Ford Health System at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma Control Test (time frame: 12 months of enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02575326, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.