Aides in Respiration Health Coaching for COPD

Not Applicable

Completed

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Behavioral: Health Coaching

• Registration Number: NCT02234284
• Lead Sponsor: 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

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 Timeline

• Study First Submitted: 2014-08-12
• Study First Submitted QC: 2014-09-08
• Study First Posted: 2014-09-09
• Study Start: 2014-11-12
• Primary Completion: 2017-05-04
• Study Completion: 2017-05-04
• Results First Submitted: 2018-02-20
• Status Verified: 2019-03
• Results First Submitted QC: 2019-03-08
• Last Update Submitted: 2019-03-08
• Results First Posted: 2019-06-10
• Last Update Posted: 2019-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 192

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Health Coaching	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

Primary Outcome Measures

Name	Time	Method
Short Form Chronic Respiratory Disease Questionnaire (CRQ-SF) Total Score	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)	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

Name	Time	Method
Rate of COPD Exacerbations Per Year	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.
Exercise Capacity (6-minute Walk Test)	9 months	Distance walked, in meters, over 6 minutes. Higher number indicates greater exercise capacity.
Self-efficacy to Manage Chronic Disease Scale	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.

Trial Locations

Locations (1)

San Francisco Departmen of Public Health Community Clinics; 🇺🇸 San Francisco, California, United States