The Development of an Integrated Physical Activity and Mental Health Intervention for Veterans With COPD, Emotion Distress, and Low Physical Activity

Launched by VA OFFICE OF RESEARCH AND DEVELOPMENT · Jun 28, 2021

Keywords

ClinConnect Summary

This clinical trial is looking at how to help Veterans who have Chronic Obstructive Pulmonary Disease (COPD), along with feelings of depression and anxiety, to become more physically active. COPD is a lung disease that can make it hard to breathe, and it often comes with emotional challenges. The main goal of this study is to create and test a program that combines physical activity with mental health support, making it easier for Veterans to improve their overall health. The program will be delivered online, so participants can join from home, which is especially helpful for those who have trouble getting to a hospital.

To be eligible for this trial, participants need to be at least 40 years old, have a diagnosis of COPD, and experience some level of emotional distress, like anxiety or depression. They should also be able to communicate, have internet access, and be willing to wear devices like a Fitbit to track their activity. Participants will take part in virtual appointments and may be asked to complete questionnaires about their health. This study is currently recruiting, and it's an exciting opportunity for Veterans looking to improve their physical and mental well-being in a supportive environment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Any gender-identified, greater than or equal to 40 years of age
• • Clinical diagnosis of COPD defined as the presence of emphysema on a CT scan and one piece of clinical evidence of COPD (defined as a ratio of FEV1 to forced vital capacity \< 0.70, \> 10 pack-year cigarette smoking history, overall assessment of COPD in their problem list or in Pulmonary/Primary Care notes, or on bronchodilators (specifically antimuscarinics such as Tiotropium or Ipratropium). If there is no evidence of emphysema, or no CT on scan in their medical chart, three pieces of clinical evidence of COPD will suffice for a clinical diagnosis of COPD.
• • Ability to communicate
• • Able to participate in in-person study appointment at the VA
• • English speaking
• • Competent to provide informed consent
• • Emotional distress. Clinically significant depression and/or anxiety defined as PHQ-8 \> 10 and/or Beck Anxiety Inventory \> 13
• • Wireless Internet connection and Bluetooth capability
• • Participants with \> 90% accuracy of device Fitbit to manual step counts
• • Agreeable to audio record study session
• • Agreeable to wearing an ActiGraphy device and Fitbit and downloading the Fitbit app
• • Email user for VVC visits links
• • Either owns a smartphone or iPad compatible with the Fitbit app and enabled with Bluetooth or agreeable to using a study-issued iPad with Wi-Fi and Bluetooth capabilities
• • Medical clearance from healthcare provider to participate in a physical activity program
• Exclusion Criteria:
• • COPD exacerbation in the previous 1 month
• • Inability to ambulate
• • Regular use of a rollator, walker, or wheelchair for ambulation
• • Inability to complete questionnaires
• • Inability to collect at least 4 valid days of 7-day baseline step count data
• • Positive screening on the Mini-Cog defined as \< 3 indicating possible cognitive impairment or dementia or major neurocognitive disorder diagnosis in electronic medical chart or refusal to complete the assessment
• • Currently enrolled in another interventional study targeting exercise, physical activity, or mental health
• • Average baseline step counts of greater than or equal to 10,000 steps per week
• • Suicide flag in chart
• • Oxygen saturation after 6-Minute Walk Test documented to be \<85%