Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers

Duke University

Status: Completed

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Behavioral: Telephone-based Enhanced Coping Skills Training (CST); Other: Usual Medical Care and COPD education and symptom monitoring (UMC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00736268

2R01HL065503-06A1 (U.S. NIH Grant/Contract)

Pro00003707

Details and patient eligibility

About

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.

Full description

Overall, 746 participants (patients and caregivers) were consented for participation into this study from both Duke University Medical Center and Ohio State University. Of these, 326 patients were randomized and participated in the study intervention along with 252 consented participants who acted as a caregiver; in total 578 participants (patients and caregivers) were involved with the study intervention.

Enrollment: 746 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• male or female outpatients 21 years of age or older
• a diagnosis of COPD
• FEV1 25%-80% of predicted value
• FEV1/FVC <70%
• capacity to give informed consent and follow study procedures

Exclusion criteria

• dementia
• psychotic features including delusions or hallucinations
• acute suicide or homicide risk
• other illness (e.g., cancer) that is likely to cause death within 3 years
• unstable angina
• congestive heart failure stage III - IV by NYHA classification
• active involvement in pulmonary rehabilitation or a formal exercise program

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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746 participants in 2 patient groups

CST

Experimental group

Description:

Telephone-based Enhanced Coping Skills Training (CST)

Treatment:

Behavioral: Telephone-based Enhanced Coping Skills Training (CST)

UMC

Other group

Description:

Usual Medical Care and COPD education and symptom monitoring (UMC)

Treatment:

Other: Usual Medical Care and COPD education and symptom monitoring (UMC)