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Supporting Evidence-based Responses to Emotional Needs in Emphysema

NCT06600126 · University of Pennsylvania
In plain English

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About this study
Social environments, including family structure and function, shape patients' care and outcomes. Yet the role of family caregivers in chronic illness care is often unrecognized or undervalued even when critically relevant. For example, psychological distress is highly prevalent among patients with chronic obstructive pulmonary disease (COPD). COPD affects more than 212 million people worldwide, annual US medical costs are over $49 billion, and groups experiencing health disparities are most affected. Family caregivers, patients, and clinicians identify emotional symptoms and coping as critical priorities in COPD care. Psychological distress is strongly associated with poor quality of life and clinical outcomes for patients with COPD, such as more frequent exacerbations and higher post-discharge mortality. Yet affected patients rarely receive psychological care, particularly patients who face barriers to behavioral health care access. Integrating families into approaches to reduce patients' psychological distress is likely to improve outcomes and equity. The investigators' overarching objective is to reduce the burden of chronic illness on patients and families. The central hypothesis is that improving patients' coping skills and caregivers' ability to coach patients in use of these skills will improve patients' outcomes. The existing evidence amongst patients with COPD is strongest for non- pharmacological interventions for psychological distress, but fails to represent diverse study populations. High-quality family relationships (i.e., cohesion, problem solving, and communication) are associated with better clinical outcomes. Among patients with COPD, better family relationship quality is associated with reduced psychological distress and improved self-management and dyspnea. Coping Skills Training is a scalable intervention that uses cognitive-behavioral skills to teach patient-caregiver dyads how to respond to the many emotional, physical, functional, and psychosocial consequences of COPD. In an NIH-funded trial of 326 dyads, Coping Skills Training improved patients' psychological and health-related quality of life more than an educational control. Yet, the mechanisms of the intervention's success remain unknown and the prior work underrepresented groups experiencing health disparities. Filling these critical knowledge gaps is an urgent need that will allow the investigators to refine and scale effective and efficient interventions addressing this critical need. The investigators propose a randomized clinical trial to test putative treatment mechanisms through which the Coping Skills Training program administered to patients with COPD and their family caregivers improves outcomes. Outpatients with COPD who screen positive for psychological distress will be randomized in a 2:1 ratio to participate in a 12-week program with a caregiver, either a Coping Skills Training program (i.e., weekly 30-minute protocolized sessions delivered by a behavioral health specialist) or COPD Education program (i.e., weekly 10-minute sessions without coping skills).
Eligibility criteria
Inclusion Criteria: Patients * Be at least 18 years of age * Have a documented diagnosis of COPD and confirmation of obstructive lung disease by spirometry (American Thoracic Society/European Respiratory Society guidelines) or radiology (imaging report indicating emphysematous changes) * Score greater than or equal to 8 during baseline screening using the PHQ-8 * Identify an adult caregiver to participate with them * Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 sessions of the study intervention * Spoken proficiency in Spanish and/or English Caregivers * Be at least 18 years of age * Have the ability to access a telephone or videoconferencing call up to once weekly (for approximately 30 minutes) for 12 weeks Exclusion Criteria: Patients * Has significant dementia or cognitive impairment * Documentation in the EHR that the COPD diagnosis has not yet been disclosed to the patient * Is under the ongoing care of a licensed behavioral health clinician * Requires immediate referral to specialized behavioral health management Caregivers * Has significant dementia or cognitive impairment
Study design
Enrollment target: 750 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2024-09-30
Estimated completion: 2028-03-05
Last updated: 2026-01-30
Interventions
Behavioral: Coping Skills TrainingBehavioral: COPD Education
Primary outcomes
  • Patient Psychological Distress (Baseline, 14 weeks)
Sponsor
University of Pennsylvania · other
With: National Institute of Nursing Research (NINR), Henry Ford Health System, Thomas Jefferson University
Contacts & investigators
ContactJoanna Hart, MD, MSHP · contact · Joanna.Hart@pennmedicine.upenn.edu · 267-271-0665
ContactDaniel Carter, PhD · contact · Daniel.Carter@pennmedicine.upenn.edu · 215-573-7082
InvestigatorJoanna Hart, MD, MSHP · principal_investigator, University of Pennsylvania
All locations (2)
Henry Ford Health SystemRecruiting
Detroit, Michigan, United States
University of PennsylvaniaRecruiting
Philadelphia, Pennsylvania, United States
Supporting Evidence-based Responses to Emotional Needs in Emphysema · TrialPath