Aides in Respiration Health Coaching for COPD

NCT02234284 | Completed Results DMC

• 1 other identifier: PCORI AD-1306-03900
• Study Type: interventional
• Target: 192
• Locations: 1 country
• Sites: 1

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

Conditions

Chronic Obstructive Pulmonary Disease (COPD)

Keywords

Chronic Obstructive Pulmonary Disease; Health Coaching; Health Disparities; Self-management; Chronic Disease Model

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (3)

• Rate of COPD Exacerbations Per Year

  Over 9 month study period

• Exercise Capacity (6-minute Walk Test)

  9 months

• Self-efficacy to Manage Chronic Disease Scale

  9 months

Other Outcomes (15)

• Short Version of the Patient Assessment of Quality of Care (PACIC)

  9 months

• COPD Assessment Test

  9 months

• Percent of Predicted Force Expiratory Volume at 1 Second (FEV1)

  9 months

Study Arms (2)

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

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.

Interventions

Health Coaching BEHAVIORAL

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.

Health Coaching

Eligibility Criteria

• Age: 40 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• or more emergency department (ED) visit for COPD exacerbation in past 12 months
• or more hospital stays for COPD exacerbation in past 12 months
• 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).

You may not qualify if:

• Unable to participate in the study due to mental or physical impairment
• Severe or terminal illness that precludes focus on COPD
• No phone

Sponsors & Collaborators

• University of California, San Francisco: lead
• Patient-Centered Outcomes Research Institute: collaborator

Study Sites (1)

San Francisco Departmen of Public Health Community Clinics

San Francisco, California, 94110, United States

Location

Related Publications (4)

• 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.

  PMID: 28599636 BACKGROUND

• 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.

  PMID: 30791871 BACKGROUND

• 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;15(10):1159-1168. doi: 10.1513/AnnalsATS.201806-365OC.

  PMID: 30130430 RESULT

• Willard-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.

  PMID: 31937527 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Target sample size was reduced from 250 to 190 due difficulties with recruitment. The outcome of medication adherence, measured by the Morisky Medication Adherence Scale, was deleted because we did not realized it required a license.

Results Point of Contact

• Title: Dr. David Thom
• Organization: University of California San Francisco

David.Thom@UCSF.edu

415-206-2278

Study Officials

• David H Thom, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 12, 2014
• First Posted: September 9, 2014
• Study Start: November 12, 2014
• Primary Completion: May 4, 2017
• Study Completion: May 4, 2017
• Last Updated: June 10, 2019
• Results First Posted: June 10, 2019

Record last verified: 2019-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)