Please select the eligibility criteria that correspond 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: Inclusion Criteria:

* post-bronchodilator forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) ratio \< 70%
* age \> 40 years
* complaints of chronic cough
* smoking history of more than 20 years or 15 pack-years
* diagnosis of COPD as major functionally limiting disease and
* current use of bronchodilator therapy.

Exclusion Criteria:

* primary diagnosis of asthma
* primary diagnosis of cardiac disease
* presence of disease that could either effect mortality or participation in the study (e.g. confusional states).
B: Inclusion criteria:

* Admitted to the hospital with a diagnosis of an acute COPD exacerbation; OR has a previous COPD diagnosis\* AND receiving treatment to control COPD symptoms - (e.g. nebulizer treatment, prednisone course, ...) in the current hospitalization
* Age \> 40 and \>10 pack-yrs smoking
* English speaking
* Anticipated discharge back to home (rather than to Hospice or long term nursing home placement)

Exclusion criteria:

* Severe cognitive dysfunction
* Terminal illness (less than 6 months life expectancy) that is non-COPD related
* Homeless (no home address)
C: 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
D: Inclusion Criteria:

* Age 40 years and older at the time of randomization;
* Have a physician diagnosis of COPD
* Have moderate to severe COPD according to GOLD classification (Stages II - III)
* Understand spoken English or Spanish
* Urgent care event due to COPD within 4 weeks of enrollment
* Have no other member of the household enrolled in the study

Exclusion Criteria:

* Evidence that the patient may move from the study area before the completion of the study
* Impaired cognitive status as indicated by MMSE\<24
* Presence of any health condition, that would preclude participation (e.g., psychiatric diagnosis, unstable cardiovascular condition or physical disability)

Answer: C