Overview

This trial is active, not recruiting.

Condition chronic obstructive pulmonary disease (copd)
Treatment health coaching
Sponsor University of California, San Francisco
Collaborator Patient-Centered Outcomes Research Institute
Start date November 2014
End date April 2017
Trial size 190 participants
Trial identifier NCT02234284, PCORI AD-1306-03900

Summary

This proposed study will examine whether health coaches can improve the management of 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 will be randomized into a health coaching group and a usual care group. Those in the health coaching group will receive 9 months of active health coaching. Outcome variables will be measured at baseline and after 9 months

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose supportive care
Arm
(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
health coaching
Major health coach activities will be: Patient COPD education; Correct use of inhalers and nebulizers; Red flags and when to seek medical care; Dyspnea management; Use of oxygen; 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; Helping patient obtain prescriptions; Identifying gaps in care, areas where care not in line with care plan; Helping patients to make and keep appointments and obtain needed testing; 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 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 Outcomes

Measure
Change in Short Form Chronic Respiratory Disease Questionnaire total score
time frame: Baseline, 3, 6 and 9 months

Secondary Outcomes

Measure
Change in COPD Assessment Test (CAT) score
time frame: Baseline, 3, 6 and 9 months
Change in Patient Assessment of Chronic Illness Care (PACIC) score
time frame: Baseline and 9 months
Change in Self-efficacy for managing COPD score
time frame: Baseline and 9 months
Change in Number of exacerbations of COPD
time frame: Baseline, 3, 6 and 9 months
Change in 6 minute walk test distance
time frame: Baseline and 9 months
Chronic Respiratory Disease Questionnaire (CRQ) dyspnea domain score
time frame: Baseline, 3, 6 and 9 months

Eligibility Criteria

Male or female participants from 40 years up to 95 years old.

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 - 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 at least 40 mg per day for at least 5 days in past 12 months - Ever on home oxygen therapy - Ever outpatient percutaneous oxygen saturation 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

Additional Information

Official title Health Coaching to Reduce Disparities for Patients With Chronic Obstructive Pulmonary Disease (COPD)
Principal investigator David H Thom, MD, PhD
Description None as would duplicate information recorded elsewhere
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University of California, San Francisco.