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Aides in Respiration Health Coaching for COPD (AIR)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02234284
Recruitment Status : Completed
First Posted : September 9, 2014
Results First Posted : June 10, 2019
Last Update Posted : June 10, 2019
Sponsor:
Collaborator:
Patient-Centered Outcomes Research Institute
Information provided by (Responsible Party):
University of California, San Francisco

Brief 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. 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

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease (COPD) Behavioral: Health Coaching Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 192 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Actual Study Start Date : November 12, 2014
Actual Primary Completion Date : May 4, 2017
Actual Study Completion Date : May 4, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arm Intervention/treatment
Experimental: Health Coaching
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
Behavioral: Health Coaching
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.

No Intervention: Usual care
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.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Rate of COPD Exacerbations Per Year [ Time Frame: Over 9 month study period ]
    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.

  2. Exercise Capacity (6-minute Walk Test) [ Time Frame: 9 months ]
    Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.

  3. Self-efficacy to Manage Chronic Disease Scale [ Time Frame: 9 months ]
    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.


Other Outcome Measures:
  1. Short Version of the Patient Assessment of Quality of Care (PACIC) [ Time Frame: 9 months ]
    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.

  2. COPD Assessment Test [ Time Frame: 9 months ]
    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.

  3. Percent of Predicted Force Expiratory Volume at 1 Second (FEV1) [ Time Frame: 9 months ]
    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.

  4. Proportion (%) of Participants Reporting Current Cigarette Use [ Time Frame: 9 months ]
    Current cigarette use is defined as any use in the past 30 days.

  5. COPD-related Function (Bed Days Due to Respiratory Problems) [ Time Frame: 9 months ]
    Number of days in past 4 weeks where COPD keep participant in bed all or most of the day.

  6. Proportion (%) of Participants Demonstrating Adequate Inhaler Use [ Time Frame: 9 months ]
    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.

  7. Proportion (%) of Participants With Correct Answer to Knowledge Question 1 [ Time Frame: 9 months ]
    Okay to get short of breath while exercising

  8. Proportion (%) of Participants With Correct Answer to Knowledge Question 2 [ Time Frame: 9 months ]
    beneficial to stop smoking

  9. Proportion (%) of Participants With Correct Answer to Knowledge Question 3 [ Time Frame: 9 months ]
    Okay to be on oxygen for long period

  10. Proportion (%) of Participants With Correct Answer to Knowledge Question 4 [ Time Frame: 9 months ]
    Smoking does not help breathing

  11. Rate of Outpatient Visits [ Time Frame: Over 9 month study period ]
    Number of outpatient visits per patient per year

  12. Rate of ED Visits for COPD [ Time Frame: Over 9 month study period ]
    Number of ED visits for COPD per patient per year over 9 month study period

  13. Rate of ED Visits Not for COPD [ Time Frame: Over 9 month study period ]
    Number of visits to emergency department other than for COPD related reason per patient per year during 9 month study period

  14. Rate of Hospitalization for COPD [ Time Frame: Over 9 month study period ]
    Number of hospitalizations for COPD per patient per year over 9 month study period

  15. Rate of Hospitalizations Not for COPD [ Time Frame: Over 9 month study period ]
    Number of hospitalizations other than for COPD per patient per year during 9 month study period



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02234284


Locations
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United States, California
San Francisco Departmen of Public Health Community Clinics
San Francisco, California, United States, 94110
Sponsors and Collaborators
University of California, San Francisco
Patient-Centered Outcomes Research Institute
Investigators
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Principal Investigator: David H Thom, MD, PhD University of California, San Francisco
  Study Documents (Full-Text)

Documents provided by University of California, San Francisco:
Study Protocol  [PDF] September 8, 2014
Statistical Analysis Plan  [PDF] September 8, 2014


Publications of Results:
Other Publications:
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT02234284    
Other Study ID Numbers: PCORI AD-1306-03900
First Posted: September 9, 2014    Key Record Dates
Results First Posted: June 10, 2019
Last Update Posted: June 10, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University of California, San Francisco:
Chronic Obstructive Pulmonary Disease
Health Coaching
Health Disparities
Self-management
Chronic Disease Model
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases