AsthmaNCT02413684
PackHealth: Asthma Engagement Tool
A study testing Patient engagement toolkit in people with Asthma, run by Duke University at 1 site in United States.
Trial summary
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Asthma
- What is being tested?
- Patient engagement toolkit
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2015to Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Who cannot join
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Asthma Allergy and Airway Center
Durham, North Carolina, 27705
About this study
Official title: Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.
Read the detailed description
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
- Conditions
- Asthma
- Being tested
- Patient engagement toolkit
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient engagement toolkitBehavioural
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care
| Study group | Role | What they receive |
|---|---|---|
| Asthma Patients | Other | Patient engagement toolkit Receives: Behavioral: Patient engagement toolkit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Asthma Exacerbations
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
Measured: 12 weeks prior to baseline
Rate of Asthma Exacerbations
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
Measured: baseline to week 13
Secondary outcomes (5)
Change in Asthma Control
Measured by the Asthma Control Test (ACT), patient self-administered tool for identifying those with poorly controlled asthma. The ACT assesses the frequency of dyspnea and general asthma symptoms, use of rescue medications, the effect of asthma on daily functioning, and overall self-assessment of asthma control. 5 items with 4-week recall. The score range is 5-25 with >19 representing good control and <18 representing poor control.
Measured: baseline, 13 weeks
Change in Asthma Symptoms
Measured by asthma symptom utility index (ASUI). The Asthma Symptom utility Index (ASUI) is a brief, interviewer-administered, patient preference-based scale assessing frequency and severity of asthma-related symptoms and treatment side effects. Number of items 11 items with 2 week recall.
Scores range from 0 (worst possible symptoms) to 1 (no symptoms) Minimal Clinically Important Difference (MCID) > 0.09
Measured: baseline, 13 weeks
Change in Pulmonary Function Tests
Measured by spirometry. We measured forced expiratory volume in one second (FEV1) and forced vital capacity both in liters. FEV1 is a measure of airflow obstruction. The change in lung function is the change in these measurements compared to baseline.
Measured: baseline, 13 weeks
Number of Emergency Department and Hospitalization Visits
Number of emergency department and hospitalizations visits will be recorded that occurred within the prior year.
Measured: Prior Year
Number of Emergency Department and Hospitalization Visits
Number of emergency department and hospitalization visits will be recorded
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2015 (estimated)
- Study startAug 2015
- Primary completionSep 2016
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Njira Lugogo, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02413684
- Sponsor's protocol ID
- Pro00057939
- Status last verified
- Dec 2017
- First submitted
- 2 Apr 2015
- Last updated
- 9 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Impact of a Patient-Clinician Engagement Tool on Patient Reported Outcomes and Engagement in Asthma
- ClinicalTrials.gov ID
- NCT02413684
- Acronym / sponsor ID
- Pro00057939
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 10 Apr 2015 (estimated)
- Results
- Posted 9 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to test the impact of an innovative patient engagement solution on patient's quality of life and asthma-related outcomes, and evaluate the correlation between a patient reported outcome measure and clinical outcomes.
Detailed description
Patient engagement is a critical part of improving patient care and outcomes. Current patient engagement strategies only focus on the patient-physician interaction and have been shown to be ineffective.
The need for a comprehensive approach to patient engagement is no different among patients with asthma as it is in any other chronic condition. Patients with asthma must make complicated health decisions daily that impact their social and occupational activities, quality of life, and treatment adherence. Obtaining, communicating, processing, and understanding non- biased health information are crucial in making appropriate and informed treatment decisions.
Pack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care. Each Pack draws on the science of change management and patient activation and contains three categories of materials
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Asthma Patients | Other | Behavioral: Patient engagement toolkitPatient engagement toolkit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with a physician diagnosis of asthma for at least the previous 12 months.
- Asthma that is not well controlled by NAEPP guidelines.
- Ability and willingness to provide informed consent
Key exclusion criteria (4 listed)
- Significant alcohol consumption of more than three alcoholic drinks per day or active substance abuse.
- Chronic disease (other than asthma) that in the opinion of the investigator would prevent participation in the trial or put the participant at risk by participation e.g. chronic diseases of the lung (other than asthma), heart, liver, kidney, endocrine or nervous system or immunodeficiency that are not well addressed or controlled.
- A diagnosis of cancer with ongoing treatment.
- Any terminal illness or conditions that results in a life expectancy less than one year.
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 |
|---|---|---|
| Patient engagement toolkitPack Health LLC and Duke will develop a patient engagement toolkit known as "Packs" to help empower and engage patients. These disease-specific, evidence-based kits are scientifically designed to improve patient involvement in their own care | Behavioural | Asthma Patients |
Primary outcome
Rate of Asthma Exacerbations
Time frame: 12 weeks prior to baseline
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations that occurred 12 weeks before baseline.
Rate of Asthma Exacerbations
Time frame: baseline to week 13
The average number of asthma events requiring treatment with oral corticosteroids, emergency room visits or hospitalizations from baseline to week 13
5 secondary outcomes
Change in Asthma Control
Time frame: baseline, 13 weeks
Change in Asthma Symptoms
Time frame: baseline, 13 weeks
Change in Pulmonary Function Tests
Time frame: baseline, 13 weeks
Number of Emergency Department and Hospitalization Visits
Time frame: Prior Year
Number of Emergency Department and Hospitalization Visits
Time frame: 13 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Njira Lugogo, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient engagement toolkit in people with Asthma, run by Duke University 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 3 inclusion and 4 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 9 Oct 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?
Yes. Results are posted in the registry (first posted 9 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Rate of Asthma Exacerbations (time frame: 12 weeks prior to baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Oct 2018.