Chronic Obstructive Pulmonary Disease (COPD)AIRNCT02234284
Aides in Respiration Health Coaching for COPD
A study testing Health Coaching in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of California, San Francisco at 1 site in United States.
Trial summary
This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Read more about this study
- Who is it for?
- Ages 40 to 95 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease (COPD)
- What is being tested?
- Health Coaching
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 192 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2014to 4 May 2017
- 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 40 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
- Age 40 and older
- Speaking English or Spanish
- Plan to continue to be seen at current clinic and to not leave the area for >2 months anytime in the next 9 months or to be absent at 9 or 15 months
- COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) <.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
- Willingness to attempt spirometry
Show all 16Show fewer
- At least moderate COPD, defined as at least one of the following:
- Ever Forced Expiratory Volume in 1 second (FEV1) < 80% predicted
- 1 or more emergency department (ED) visit for COPD exacerbation in past 12 months
- 1 or more hospital stays for COPD exacerbation in past 12 months
- 1 or more prescriptions for oral prednisone for a COPD exacerbation in past 12 months
- Ever on home oxygen therapy
- Ever outpatient percutaneous oxygen saturation of </=88%
- Ever outpatient partial pressure of oxygen (ppO2) by arterial blood gas (ABG) of </=55mm Hg
- At least 3 outpatient visits for COPD in past 12 months AND (a current COPD Assessment Test (CAT) score of >/=10 OR an modified Medical Research Council (mMRC) score of >/=2).
- Currently using tiotropium inhaler or combination inhaled corticosteroid and long-acting beta agonist
Who cannot join
- Unable to participate in the study due to mental or physical impairment
- Severe or terminal illness that precludes focus on COPD
- No phone
Trial locations and contacts
1 site in 1 country.
United States1 site
San Francisco Departmen of Public Health Community Clinics
San Francisco, California, 94110
About this study
Official title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months
Read the detailed description
Health coaching is a promising model for improving evidence-based care for patients with COPD which had not been evaluated at the time the current study began in 2014. Health coaching by health workers or peers trained as coaches, has emerged as an effective model to improve these management domains for children with asthma and adults with diabetes, and hypertension receiving care in urban safety-net clinics. The role of the health coach includes many of the activities also provided by patient navigators, patient educators, and community health workers. Health coaching is a patient-centered model that recognizes that that people living with chronic disease are the primary decision-makers in their care; it is a tailored approach that builds on the strengths and expertise of patients and helps to ensure that they have the knowledge and skills to be active participants within the medical encounter and to effectively manage their conditions. Incorporating health coaches into care delivery fits well with the of integrated care model recommended by the American Thoracic Society which is based on the Chronic Care Mode. Health coaching can work on several components of the Chronic Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote patient goals. Health coaches provide decision support by helping execute customized care plans jointly developed by patients and providers. Coaches track care targets and conduct 'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the support they need by facilitating access to community, clinic, and specialist support, improving communication between patients and providers, working with patients to set goals and develop action plans to reach those goals. The goal of our study was to evaluate the effectiveness of a health coach model for improving outcomes for low-income urban patients with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual care (health coached arm) to usual care (usual care arm) alone for patients with moderate to severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of the study were:
Specific Aim 1. To compare disease specific quality of life for patients randomized to receive 9 months of health coaching plus usual care to those randomized to usual care alone. Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients in the health-coached arm when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the health coached arm to those in the usual care arm during the 9 month period starting at enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer exacerbations when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached arm to those in the usual care arm. Our hypothesis was that patients in the health-coached arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the health coached arm when tested against the null hypothesis of no difference in self-efficacy between health-coached and usual care patients.
- Being tested
- Health Coaching
- Keywords
- Chronic Obstructive Pulmonary Disease, Health Coaching, Health Disparities, Self-management, Chronic Disease Model
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health CoachingBehavioural
Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers.
| Study group | Role | What they receive |
|---|---|---|
| Health Coaching | Experimental | Patients randomized to the health coaching intervention would work with a trained health coach who would provide patient education self-management support, use action planning to help patient make changes to reach goals, as well as help coordinate patient care between the primary care provider and pulmonary specialist, identify gaps in care, and help patient access needed services Receives: Behavioral: Health Coaching |
| Usual care | No intervention | Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score
The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.
Measured: 9 months
Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)
The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.
Measured: 9 months
Secondary outcomes (3)
Rate of COPD Exacerbations Per Year
A COPD exacerbation was defined as a COPD-related emergency department visit or hospitalization, or the outpatient prescription of oral steroids and/or antibiotic for COPD-related diagnosis, as documented in the medical record over the 9 month trial period. The rate of COPD exacerbation was calculated as the mean number of exacerbations per participant per year.
Measured: Over 9 month study period
Exercise Capacity (6-minute Walk Test)
Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
Measured: 9 months
Self-efficacy to Manage Chronic Disease Scale
The Self-efficacy to Manage Chronic Disease Scale is a validated measure of of patient self-efficacy for managing a specific chronic disease (in this case, COPD). The Self-efficacy to Manage Chronic Disease Scale has 6 items asking about patients' self-confidence dealing with 6 aspects off self-management. Each item is answered on a scale of 1 to 10 with 1="not at all confident" and 10='totally confident". The score is the mean of all 10-items. Mean scores range for 1 to 10, with a higher score indicating greater self-efficacy for managing COPD.
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2014 (estimated)
- Study start12 Nov 2014
- Primary completion4 May 2017
- Study completion4 May 2017
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.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary Disease (COPD)Studies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 192 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Responsible party
- Sponsor
- Investigators
- David H Thom, MD, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02234284
- Sponsor's protocol ID
- PCORI AD-1306-03900
- Acronym
- AIR
- Status last verified
- Mar 2019
- First submitted
- 12 Aug 2014
- Last updated
- 10 Jun 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3.
PubMed 28599636Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y.
PubMed 30791871Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
PubMed 30130430Willard-Grace R, Chirinos C, Wolf J, DeVore D, Huang B, Hessler D, Tsao S, Su G, Thom DH. Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial. Ann Fam Med. 2020 Jan;18(1):5-14. doi: 10.1370/afm.2461.
PubMed 31937527
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
- ClinicalTrials.gov ID
- NCT02234284
- Acronym / sponsor ID
- AIR / PCORI AD-1306-03900
- Keywords
- Chronic Obstructive Pulmonary Disease, Health Coaching, Health Disparities, Self-management, Chronic Disease Model
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 192 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- Patient-Centered Outcomes Research Institute
- Study start
- 12 Nov 2014 (actual)
- Primary completion
- 4 May 2017 (actual)
- Study completion
- 4 May 2017 (actual)
- First posted
- 9 Sep 2014 (estimated)
- Results
- Posted 10 Jun 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examined whether health coaches can improve the management of chronic obstructive pulmonary disease (COPD) in a population of vulnerable patients cared for in 'safety-net' clinics. The study is designed as a randomized controlled trial for patients with moderate to severe COPD. Patients were randomized into a health coaching group and a usual care group. Those in the health coaching group received 9 months of active health coaching. Outcome variables were measured at baseline and after 9 months
Detailed description
Health coaching is a promising model for improving evidence-based care for patients with COPD which had not been evaluated at the time the current study began in 2014. Health coaching by health workers or peers trained as coaches, has emerged as an effective model to improve these management domains for children with asthma and adults with diabetes, and hypertension receiving care in urban safety-net clinics. The role of the health coach includes many of the activities also provided by patient navigators, patient educators, and community health workers. Health coaching is a patient-centered model that recognizes that that people living with chronic disease are the primary decision-makers in their care; it is a tailored approach that builds on the strengths and expertise of patients and helps to ensure that they have the knowledge and skills to be active participants within the medical encounter and to effectively manage their conditions. Incorporating health coaches into care delivery fits well with the of integrated care model recommended by the American Thoracic Society which is based on the Chronic Care Mode. Health coaching can work on several components of the Chronic Care Model as it applies to COPD to enhance the effectiveness of care delivery and promote patient goals. Health coaches provide decision support by helping execute customized care plans jointly developed by patients and providers. Coaches track care targets and conduct 'gap analysis' to identify areas which are sub-optimal. Coaches also help patients to get the support they need by facilitating access to community, clinic, and specialist support, improving communication between patients and providers, working with patients to set goals and develop action plans to reach those goals. The goal of our study was to evaluate the effectiveness of a health coach model for improving outcomes for low-income urban patients with COPD. We conducted a randomized trial comparing 9 months of health coaching plus usual care (health coached arm) to usual care (usual care arm) alone for patients with moderate to severe COPD cared for at 7 federally qualified health centers (FQHCs). The specific aims of the study were:
Specific Aim 1. To compare disease specific quality of life for patients randomized to receive 9 months of health coaching plus usual care to those randomized to usual care alone. Our hypothesis was that mean quality of life, assessed by the Chronic Respiratory Disease Questionnaire total score and dyspnea domain score at 9 months, would be greater in patients in the health-coached arm when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 2. To compare the number of exacerbations of COPD experienced by patients in the health coached arm to those in the usual care arm during the 9 month period starting at enrollment. COPD exacerbation was defined as an emergency department visit or hospitalization for COPD-related diagnosis or the outpatient prescription of oral steroids for COPD-related diagnosis. Our hypothesis was patients in the health-coached arm would experience fewer exacerbations when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 3. To compare exercise capacity at 9 months for patients in the health-coached arm to those in the usual care arm. Our hypothesis was that patients in the health-coached arm would have greater exercises capacity as measured by the 6-minute Walk Test when tested against the null hypothesis of no difference between health-coached and usual care patients.
Specific Aim 4. To compare self-efficacy for management of their COPD for health-coached versus usual care patients at 9 months. Our hypothesis was that mean self-efficacy, as measured by Stanford Chronic Disease Self-Efficacy Scale would be greater in patients in the health coached arm when tested against the null hypothesis of no difference in self-efficacy between health-coached and usual care patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Health Coaching | Experimental | Behavioral: Health CoachingPatients randomized to the health coaching intervention would work with a trained health coach who would provide patient education self-management support, use action planning to help patient make changes to reach goals, as well as help coordinate patient care between the primary care provider and pulmonary specialist, identify gaps in care, and help patient access needed services |
| Usual care | No intervention | –Usual care was chosen as the comparison group to provide maximum generalizability of the study, as usual care is the practical alternative for the target population. Usual care includes patient education classes, smoking cessation classes, psychosocial medicine and nutritional counseling. |
Who may qualify
- Ages
- 40 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patient at one of the participating primary care clinics (at least 1 visit in past 12 months)
- Age 40 and older
- Speaking English or Spanish
- Plan to continue to be seen at current clinic and to not leave the area for >2 months anytime in the next 9 months or to be absent at 9 or 15 months
- COPD defined as ever having had a post-bronchodilator Forced Expiratory Volume in 1 second/Forced Vital Capacity (FEV1/FVC) <.70 of FEV1/FVC of .70 to .74 and diagnosis of COPD by the study pulmonologist
Key exclusion criteria (3 listed)
- Unable to participate in the study due to mental or physical impairment
- Severe or terminal illness that precludes focus on COPD
- No phone
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 |
|---|---|---|
| Health CoachingPatient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Patient decision making and action plans around, exercise, smoking cessation; nutrition, exacerbations; Ensuring appropriate preventive services (pneumovax, flu); Depression screening; Reinforcing clinician education and use of treatment guidelines by primary care providers; Identifying gaps in care, areas where care not in line with care plan; Facilitating communication between patients, pulmonary specialists and primary care providers; Connecting with community resources; Access to psychosocial services; Working with pulmonary specialist to provide recommended exercise program; Working with patient family members and caregivers. | Behavioural | Health Coaching |
Primary outcome
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score
Time frame: 9 months
The Chronic Respiratory Disease Questionnaire assesses disease-related quality of in 4 domains (dyspnea, fatigue, physical function and mastery). The 8-item Short Form version has been validated against the original full version. Each item is answered on a 7-point response scale where a higher score indicates a higher quality of life. The measure is scored as the mean response score (range 1 to 7) for each domain and for the total score, with the higher score indicating higher quality of life.
Dyspnea Domain Score of the Short Form of the Chronic Respiratory Disease Questionnaire (CRQ-SF)
Time frame: 9 months
The CRQ-SF is the short-form version of the original Chronic Respiratory Disease Questionnaire. The CRQ-SF has a total of 8 items asking about the frequency of COPD-related symptoms in 4 domains (2 questions per domain): Dyspnea, Fatigue, Emotional Function and Mastery. Each item is answered on a 7-point Likert-type scale with 1=none of the time and 7=all of the time. The dyspnea score is reported as the mean of the two items asking about shortness of breath. Mean scores range for 1 to 7, with a higher score indicating a worse quality of life related to dyspnea.
3 secondary outcomes
Rate of COPD Exacerbations Per Year
Time frame: Over 9 month study period
Exercise Capacity (6-minute Walk Test)
Time frame: 9 months
Self-efficacy to Manage Chronic Disease Scale
Time frame: 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28599636Huang B, Willard-Grace R, De Vore D, Wolf J, Chirinos C, Tsao S, Hessler D, Su G, Thom DH. Health coaching to improve self-management and quality of life for low income patients with chronic obstructive pulmonary disease (COPD): protocol for a randomized controlled trial. BMC Pulm Med. 2017 Jun 9;17(1):90. doi: 10.1186/s12890-017-0433-3.
- Background: PubMed 30791871Huang B, De Vore D, Chirinos C, Wolf J, Low D, Willard-Grace R, Tsao S, Garvey C, Donesky D, Su G, Thom DH. Strategies for recruitment and retention of underrepresented populations with chronic obstructive pulmonary disease for a clinical trial. BMC Med Res Methodol. 2019 Feb 21;19(1):39. doi: 10.1186/s12874-019-0679-y.
- Results publication: PubMed 30130430Thom DH, Willard-Grace R, Tsao S, Hessler D, Huang B, DeVore D, Chirinos C, Wolf J, Donesky D, Garvey C, Su G. Randomized Controlled Trial of Health Coaching for Vulnerable Patients with Chronic Obstructive Pulmonary Disease. Ann Am Thorac Soc. 2018 Oct;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.
- Derived from this study: PubMed 31937527Willard-Grace R, Chirinos C, Wolf J, DeVore D, Huang B, Hessler D, Tsao S, Su G, Thom DH. Lay Health Coaching to Increase Appropriate Inhaler Use in COPD: A Randomized Controlled Trial. Ann Fam Med. 2020 Jan;18(1):5-14. doi: 10.1370/afm.2461.
- Individual participant dataSharing planned: No
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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.
David H Thom, MD, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Health Coaching in people with Chronic Obstructive Pulmonary Disease (COPD), run by University of California, San Francisco 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 16 inclusion and 3 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 10 Jun 2019. 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 10 Jun 2019). 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?
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score (time frame: 9 months). 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?
On the ClinicalTrials.gov record for NCT02234284, which also lists 4 linked publications.
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 10 Jun 2019.