Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Brief Summary: This study is an NIH-funded clinical trial conducted at Duke University Medical Center and Ohio State University. The purpose of this study is to examine the effects of a telephone-based, care-giver assisted, coping skills training (CST) program in patients with Chronic Obstructive Pulmonary Disease (COPD) and their caregivers. This may help COPD patients and their caregivers to deal better with the stress of lung disease. This study will test 3 primary hypotheses: 1) That enhanced CST will be more effective in improving quality of life compared to a Usual Medical Care plus COPD education and symptom management control group; 2) That enhanced CST will be associated with better medical outcomes (i.e., greater survival and fewer COPD-related physician visits or hospitalizations) compared to Controls over a follow-up period of up to 4 years; and 3) That improvements in quality of life and survival will be mediated by increased functional capacity and better coping.

This proposed study builds upon our prior research by: a) adapting and refining our CST protocol, which was effective in improving psychosocial adjustment in patients awaiting lung transplantation, to a broader population of patients with COPD who are not immediate candidates for lung transplantation; b) enhancing our intervention to improve functional capacity, reduce somatic symptoms, and improve survival; c) examining the impact of CST on medical expenditures; and d) including caregivers in an enhanced CST intervention.


Options:
A: Arm Label: 18 mcg tiotropium; Type: ACTIVE_COMPARATOR; Interventions: Drug: Tiotropium | Arm Label: Placebo; Type: PLACEBO_COMPARATOR; Interventions: Drug: Placebo | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: DRUG; Name: Tiotropium; Assigned to Arm(s): 18 mcg tiotropium | Intervention Type: DRUG; Name: Placebo; Assigned to Arm(s): Placebo
B: Arm Label: Pulmonary Rehabilitation; Type: EXPERIMENTAL; Interventions: Behavioral: Pulmonary Rehabilitation | Arm Label: Control; Type: NO_INTERVENTION; Interventions: N/A | Intervention Type: BEHAVIORAL; Name: Pulmonary Rehabilitation; Assigned to Arm(s): Pulmonary Rehabilitation
C: Arm Label: CST; Type: EXPERIMENTAL; Interventions: Behavioral: Telephone-based Enhanced Coping Skills Training (CST) | Arm Label: UMC; Type: OTHER; Interventions: Other: Usual Medical Care and COPD education and symptom monitoring (UMC) | Intervention Type: BEHAVIORAL; Name: Telephone-based Enhanced Coping Skills Training (CST); Assigned to Arm(s): CST | Intervention Type: OTHER; Name: Usual Medical Care and COPD education and symptom monitoring (UMC); Assigned to Arm(s): UMC
D: Arm Label: Inspiratory Muscle Training; Type: EXPERIMENTAL; Interventions: Procedure: Inspiratory Muscle Training | Arm Label: Sham IMT; Type: PLACEBO_COMPARATOR; Interventions: Procedure: Inspiratory Muscle Training | Intervention Type: PROCEDURE; Name: Inspiratory Muscle Training; Assigned to Arm(s): Inspiratory Muscle Training, Sham IMT

Answer: C