Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||18 Years - 99 Years|
Inclusion Criteria:- Veterans enrolled in VA Eastern Colorado Health Care System or VA Puget - Sound Health Care System - Diagnosis of CHF, pulmonary fibrosis, or COPD in 2 years prior to enrollment - High risk for hospitalization and death - Poor quality of life - Symptomatic - Primary care or other provider who is willing to facilitate intervention medical recommendations - Able to read and understand English - Consistent access to and able to use a standard telephone
Exclusion Criteria:- Previous diagnosis of dementia - Active substance abuse - Comorbid metastatic cancer - Nursing home resident - Heart or lung transplant or left ventricular assist device (LVAD) - Currently receiving hospice, palliative or home-based primary care - Currently pregnant - Currently a prisoner
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
|VA Office of Research and Development|
The person who is responsible for the scientific and technical direction of the entire clinical study.
|David Bekelman, MD MPH|
|Principal Investigator Affiliation||Rocky Mountain Regional VA Medical Center, Aurora, CO|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Heart Failure, Pulmonary Disease, Chronic Obstructive, Emphysema, Pulmonary Fibrosis, Interstitial Lung Disease|
Chronic heart failure (CHF), chronic obstructive pulmonary disease (COPD) and interstitial lung disease (i.e., pulmonary fibrosis) have commonalities that make them ideal for early palliative care provided alongside disease-specific treatments. Quality of life is reduced in these illnesses because, despite disease-specific treatments, the same symptoms (e.g., shortness of breath, fatigue) often persist in these illnesses. Quality of life is also reduced because between 50-60% of people with either illness have clinically significant depressive symptoms. Finally, while CHF, COPD, and interstitial lung disease are leading causes of hospitalization and mortality, few people with these illnesses engage in advance care planning. Providing palliative care concomitantly with other medical care offers an important opportunity to improve quality of life and advance care planning for people with CHF, COPD, or interstitial lung disease. For other conditions such as lung cancer, when provided early, prior to the end of life, palliative care improves quality of life, depressive symptoms, and survival while reducing health care utilization. While palliative care has been well-studied in patients with advanced cancer, it has not been adequately studied in CHF, COPD, or interstitial lung disease. The goal of this project is to determine whether the benefits of early palliative care extend to CHF, COPD or interstitial lung disease. The investigators developed and demonstrated early success with a patient-centered palliative care intervention to improve quality of life (i.e., symptoms, function) and advance care planning in CHF and COPD. The intervention consists of the following components:
- (1) algorithm-guided management of breathlessness, fatigue, and pain, provided by a nurse; the algorithms supplement disease-focused treatments with palliative and behavioral treatments; (2) a 6-session psychosocial care program targeting adjustment to illness and depression, provided by a social worker; and (3) engagement of patients and providers in advance care planning.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.