Clinical trial NCT00736268: Coping Skills for Patients With Chronic Obstructive Pulmonary Disease (COPD) and Their Caregivers
Official title: Telephone-based Intervention for Patients With COPD and Their Caregivers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Lung Disease
Chronic Bronchitis
Emphysema
Caregiver stress
COPD
Chronic Obstructive Pulmonary Disease
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2008-08-15
Enrollment: 746
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Composite measure of psychological quality of life, composite index of all cause mortality and COPD-related hospitalization.
timeFrame: 4 years
Secondary outcomes:
measure: Composite measure of somatic quality of life
timeFrame: 4 months and up to 4 years
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Columbus
country: United States
facility: Ohio State University
state: Ohio
Study officials:
References:
citation: Blumenthal JA, Babyak MA, Keefe FJ, Davis RD, Lacaille RA, Carney RM, Freedland KE, Trulock E, Palmer SM. Telephone-based coping skills training for patients awaiting lung transplantation. J Consult Clin Psychol. 2006 Jun;74(3):535-44. doi: 10.1037/0022-006X.74.3.535.
citation: Martinu T, Babyak MA, O'Connell CF, Carney RM, Trulock EP, Davis RD, Blumenthal JA, Palmer SM; INSPIRE Investigators. Baseline 6-min walk distance predicts survival in lung transplant candidates. Am J Transplant. 2008 Jul;8(7):1498-505. doi: 10.1111/j.1600-6143.2008.02264.x.
citation: Emery CF, Leatherman NE, Burker EJ, MacIntyre NR. Psychological outcomes of a pulmonary rehabilitation program. Chest. 1991 Sep;100(3):613-7. doi: 10.1378/chest.100.3.613.
citation: Blumenthal JA, Emery CF, Smith PJ, Keefe FJ, Welty-Wolf K, Mabe S, Martinu T, Johnson JJ, Babyak MA, O'Hayer VF, Diaz PT, Durheim M, Baucom D, Palmer SM. The effects of a telehealth coping skills intervention on outcomes in chronic obstructive pulmonary disease: primary results from the INSPIRE-II study. Psychosom Med. 2014 Oct;76(8):581-92. doi: 10.1097/PSY.0000000000000101.