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:

For COPD subjects: Male or female, age of 40 years or older, smoking history \>10 pack-years, symptomatic defined as baseline dyspnea index focal score of 9 or more and / or daily cough with production of sputum for three months per year during at least two consecutive years, diagnosis of early stage COPD according to: post-bronchodilator FEV1/FVC ratio \<70%., FEV1 \>/=50% post-bronchodilator predicted normal, and a decreased Inspiratory Capacity during exercise. For Age / Gender Matched Controls: Male or female, age of 40 years or older, nonsmoker, with no significant diseases.

Exclusion criteria:

Patients with a significant disease other than COPD; a significant disease is defined as a disease which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the study, (ii) influence the results of the study, or (iii) cause concern regarding the patient's ability to participate in the study.

Patients with a history of asthma, Patients requiring the use of supplemental oxygen therapy, Patients who have a limitation of exercise performance as a result of factors other than fatigue or exertional dyspnoea, such as arthritis in the leg, angina pectoris, claudication or other conditions, or Patients with contraindications to exercise.

Note: Additional exclusion criteria for Age / Gender Matched Controls: Patients with a significant disease including COPD.
B: Inclusion Criteria:

Clinically stable patients with COPD will be recruited from the academic centers' Outpatient Clinic on the following entry criteria:

1. a post-bronchodilator forced expiratory volume in one second (FEV1) \<70% predicted without significant reversibility (\<12% change of the initial FEV1 value or \<200 ml) and
2. optimal medical therapy according to Global Initiative for Chronic Obstructive Lung Disease (GOLD) (6).

Exclusion Criteria:

1. Orthopedic, neurological, and other musculoskeletal complaints that could impair normal movement patterns,
2. respiratory diseases other than COPD (e.g. asthma),
3. hospital admission or COPD exacerbations within the previous 4 weeks
4. patients not on optimal pharmacotherapy.
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:

* Patients with COPD
* Eligible to participate in a exercise training intervention of 8 weeks
* Pi,max \<60cmH2O or \<50% of the predicted normal value

Exclusion Criteria:

* Major comorbidities preventing successful participation in an 8 week exercise training intervention

Answer: C