Skip to main content
OpenTrials
Completed

NCT Number: NCT00736268

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Obstructive Pulmonary Disease Behavior Behavioral Symptoms Bronchial Diseases Bronchitis Bronchitis, Chronic Caregiver Burden Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections Stress, Psychological

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke University Medical Center, Durham, North Carolina, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Telephone-based Enhanced Coping Skills Training (CST)

Behavioral

Telephone-based Enhanced Coping Skills Training (CST) intervention will systematically train participants (and caregivers) in the use of coping skills for symptom management (i.e. activity pacing, pleasant activity scheduling, communications, relaxation, goal setting, imagery, calming self-statements, problem solving, and preventing and dealing with setbacks). Participants in the CST condition will receive 12 weekly 30 minute telephone sessions followed by 2 bi-weekly booster sessions for training in symptom management strategies. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.

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

Other

COPD usual care plus education and symptom monitoring control condition will participate in a weekly 15 minute phone call followed by 2 bi-weekly phone calls, assessing their health status and providing them with support and COPD education. COPD Education topics include types of lung disease, oxygen use, medication management, preventing infection, managing daily activities, and nutrition. Participants and caregivers will be evaluated at baseline, at the conclusion of 4 months of treatment, and at annual follow-up intervals for up to 4 years.

Primary outcomes

  1. Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization.

    Time frame: 4 years

Secondary outcomes

  1. Composite measure of somatic quality of life

    Time frame: 4 months and up to 4 years

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Telephone-based Intervention for Patients With COPD and Their Caregivers

Important dates

Study start
2008
Primary completion
2013
First posted
Aug 15, 2008
Registry last updated
Aug 7, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.