title: Caregiver-assisted coping skills training for patients with COPD: background, design, and methodological issues for the INSPIRE-II study.
abstract: BACKGROUND
  Chronic Obstructive Pulmonary Disease (COPD) is a progressive illness characterized by airflow obstruction and dyspnea that afflicts over 12 million people and represents a leading cause of death in the United States. Not surprisingly, COPD is often associated with emotional distress and reduced psychosocial adjustment, which can negatively impact physical functioning and impair quality of life. However, the psychosocial consequences of COPD remain largely untreated. A previous randomized trial from our research team demonstrated that coping skills training (CST) can improve pulmonary-specific quality of life among pulmonary patients awaiting lung transplant (the INSPIRE study). To date, however, no studies have examined the effects of a caregiver-assisted CST intervention in patients with COPD with less severe disease.
  
  
  OBJECTIVE
  INSPIRE II is a randomized clinical trial (RCT) funded by the NHLBI to evaluate the effects of telephone-based enhanced CST for patients with COPD and their caregivers compared to standardized medical care (SMC) including COPD education and symptom monitoring on medical outcomes, physical functioning, and quality of life.
  
  
  METHODS
  Six hundred COPD patients and their respective caregivers recruited from Duke University and Ohio State University will be evaluated and randomized (in a 1:1 ratio) to enhanced CST (including sessions promoting physical activity, relaxation, cognitive restructuring, communication skills, and problem solving) or to SMC. The primary outcomes include all-cause mortality, COPD-related hospitalizations/ physician visits, and quality of life. These endpoints will be measured through self-report questionnaires, behavioral measures of functional capacity (i.e., accelerometer and six minute walk test) and pulmonary function tests (e.g., FEV(1)).
  
  
  RESULTS
  This article reviews prior studies in the area and describes the design of INSPIRE-II. Several key methodological issues are discussed including the delivery of CST over the telephone, encouraging physical activity, and inclusion of caregivers as patient coaches to enhance the effectiveness of the intervention.
  
  
  CONCLUSIONS
  We recognize that SMC does not adequately control for attention, support, and non-specific factors, and that, in theory, non-specific effects of the intervention could account for some, or all, of the observed benefits. However, our fundamental question is whether the telephone intervention produces benefits over-and-above the usual care that patients typically receive. The SMC condition will provide education and additional weekly telephone contact, albeit less than the attention received by the CST group. We recognize that this attention control condition may not provide equivalent patient contact, but it will minimize group differences due to attention. We considered several alternative designs including adding a third usual care only arm as well as an education only control arm. However, these alternatives would require more patients, reduce the power to detect significant effects of our primary medical endpoints, and add a significant additional expense to the cost of the study that would make such an undertaking neither scientifically or financially viable.
  
  
  CONCLUSIONS
  We believe that this novel approach to patient care in which caregivers are used to assist in the delivery of coping skills training to patients with COPD has the potential to change the way in which COPD patients are routinely managed in order to reduce distress, enhance quality of life, and potentially improve medical outcomes.
authors.affiliation: Department of Psychiatry and Behavioral Sciences, Duke University Medical Center, Durham, NC 27710, USA. Blume003@mc.duke.edu
authors.forename: James A
authors.initials: JA
authors.lastname: Blumenthal
authors.forename: Francis J
authors.initials: FJ
authors.lastname: Keefe
authors.forename: Michael A
authors.initials: MA
authors.lastname: Babyak
authors.forename: C Virginia
authors.initials: CV
authors.lastname: Fenwick
authors.forename: Julie M
authors.initials: JM
authors.lastname: Johnson
authors.forename: Kylie
authors.initials: K
authors.lastname: Stott
authors.forename: Rachel K
authors.initials: RK
authors.lastname: Funk
authors.forename: Meredith J
authors.initials: MJ
authors.lastname: McAdams
authors.forename: Scott
authors.initials: S
authors.lastname: Palmer
authors.forename: Tereza
authors.initials: T
authors.lastname: Martinu
authors.forename: Don
authors.initials: D
authors.lastname: Baucom
authors.forename: Philip T
authors.initials: PT
authors.lastname: Diaz
authors.forename: Charles F
authors.initials: CF
authors.lastname: Emery