Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— AIROfficial title:
Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Verified date | March 2019 |
Source | University of California, San Francisco |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
Status | Completed |
Enrollment | 192 |
Est. completion date | May 4, 2017 |
Est. primary completion date | May 4, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 95 Years |
Eligibility |
Inclusion Criteria: - 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 - 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 Exclusion Criteria: - Unable to participate in the study due to mental or physical impairment - Severe or terminal illness that precludes focus on COPD - No phone |
Country | Name | City | State |
---|---|---|---|
United States | San Francisco Departmen of Public Health Community Clinics | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, San Francisco | Patient-Centered Outcomes Research Institute |
United States,
Huang 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. — View Citation
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. Erratum in: BMC Pulm Med. 2019 May 21;19(1):96. — View Citation
Thom 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;1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Short Version of the Patient Assessment of Quality of Care (PACIC) | Patient Assessment of Chronic Illness Care (PACIC) is a patient reported measure of having received services recommended by Chronic Care Model. The short version of the PACIC has 11 items asking the patient the proportion of time he or she received a specific service. Each item is answered on a 5-point Likert-type scale with 1=None of the time and 5=Always. The total score is the mean of all 11-items. Mean scores range for 1 to 5, with a higher score indicating higher quality of care. | 9 months | |
Other | COPD Assessment Test | The COPD Assessment Test (CAT) is an 8-item measure of severity of COPD symptoms, with responses from 1 to 5 . It is scored as the sum of item scores, with a range from 8 to 40, with a higher score indicating greater level of symptoms. | 9 months | |
Other | Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) | Volume of air exhaled, using maximal force, over 1 second, divided by the volume expected for health person of same age and gender. Larger volume indicates better lung function. | 9 months | |
Other | Proportion (%) of Participants Reporting Current Cigarette Use | Current cigarette use is defined as any use in the past 30 days. | 9 months | |
Other | COPD-related Function (Bed Days Due to Respiratory Problems) | Number of days in past 4 weeks where COPD keep participant in bed all or most of the day. | 9 months | |
Other | Proportion (%) of Participants Demonstrating Adequate Inhaler Use | Observational measure using a check list to document mistakes in using inhalers. Adequate use defined as correctly performing all necessary steps for every inhaler used. Definition of necessary steps varies by type of inhaler. | 9 months | |
Other | Proportion (%) of Participants With Correct Answer to Knowledge Question 1 | Okay to get short of breath while exercising | 9 months | |
Other | Proportion (%) of Participants With Correct Answer to Knowledge Question 2 | beneficial to stop smoking | 9 months | |
Other | Proportion (%) of Participants With Correct Answer to Knowledge Question 3 | Okay to be on oxygen for long period | 9 months | |
Other | Proportion (%) of Participants With Correct Answer to Knowledge Question 4 | Smoking does not help breathing | 9 months | |
Other | Rate of Outpatient Visits | Number of outpatient visits per patient per year | Over 9 month study period | |
Other | Rate of ED Visits for COPD | Number of ED visits for COPD per patient per year over 9 month study period | Over 9 month study period | |
Other | Rate of ED Visits Not for COPD | Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period | Over 9 month study period | |
Other | Rate of Hospitalization for COPD | Number of hospitalizations for COPD per patient per year over 9 month study period | Over 9 month study period | |
Other | Rate of Hospitalizations Not for COPD | Number of hospitalizations other than for COPD per patient per year during 9 month study period | Over 9 month study period | |
Primary | 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. | 9 months | |
Primary | 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. | 9 months | |
Secondary | 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. | Over 9 month study period | |
Secondary | Exercise Capacity (6-minute Walk Test) | Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity. | 9 months | |
Secondary | 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. | 9 months |
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