Virtual Care Optimization for COPD Management

(VC-OPTIONS Trial)

Not yet recruiting at 1 trial location

Overseen By Saige M Calkins, MA BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Prior participation, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 5

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help people with chronic obstructive pulmonary disease (COPD) manage their condition using virtual care services. The study employs a program called VC-OPTIONS (a virtual care optimization program) to send information via text messages, assisting participants in learning about digital tools for health management. It suits U.S. veterans with COPD who use VA healthcare and have a phone capable of receiving texts. The trial seeks to demonstrate that this approach is user-friendly and beneficial in enhancing access to virtual care. As an unphased trial, it provides participants the opportunity to explore innovative virtual care solutions tailored to their needs.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems focused on virtual care services for managing COPD, so it's likely you can continue your current treatment, but you should confirm with the trial organizers.

What prior data suggests that this protocol is safe for COPD management?

A previous study showed that virtual care (VC) services help manage chronic conditions like chronic obstructive pulmonary disease (COPD). However, few people have started using these services. This trial tests the VC-OPTIONS plan, which aims to increase awareness and use of these services. As a feasibility trial, its main goal is to determine if the approach is practical and acceptable for patients.

The VC-OPTIONS plan itself poses no specific safety concerns, as it primarily involves sharing information about existing virtual services through the Annie texting program. This program empowers patients by increasing their knowledge about VC services, which have been safely used in managing other chronic conditions. The trial is in an early phase, focusing on how well this strategy is received rather than identifying safety risks.

Overall, previous research supports that virtual care can be a safe and effective tool for managing chronic conditions, including COPD, without introducing new safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about VC-OPTIONS because it offers a fresh approach to managing COPD by using virtual care. Unlike traditional treatments that often require in-person visits and medication adjustments, VC-OPTIONS leverages the Annie texting protocol to provide real-time support and monitoring for patients. This method could lead to more personalized care and quicker adjustments to treatment plans, improving overall patient outcomes and convenience.

What evidence suggests that the VC-OPTIONS protocol is effective for COPD management?

Research shows that virtual care can effectively manage long-term illnesses like COPD, a lung disease that makes breathing difficult. Studies have found that early treatment through digital healthcare helps people with COPD manage their symptoms better. However, many people remain unaware of or do not use these virtual care services. This trial will enroll participants in the VC-OPTIONS program, which aims to change this by providing information through the Annie texting service. This approach is expected to help more people access and benefit from virtual care for managing COPD. Initial findings suggest that increasing awareness of these services can greatly improve COPD management. ^{4 5 6 7 8}

Who Is on the Research Team?

Stephanie Robinson, PhD

Principal Investigator

VA Bedford HealthCare System, Bedford, MA

Are You a Good Fit for This Trial?

This trial is for US Veterans who are users of the Veterans Health Administration (VHA), have been diagnosed with COPD, can communicate in English, and own a text-enabled phone. It's not open to those who've already taken part in research preparing for this intervention.

Inclusion Criteria

the ability to speak and understand English

This criterion is not clear. Can you please provide more context or specify what "VHA user" refers to in this context?

I have been diagnosed with COPD.

Exclusion Criteria

Prior participation in preparatory research for the development of the intervention

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive educational content about virtual care for COPD via Annie text messaging

12 weeks

Text messages up to 5 times per week

Follow-up

Participants are monitored for changes in awareness and intention to adopt virtual care services

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• VC-OPTIONS

Trial Overview The study is testing VC-OPTIONS, an approach designed to increase virtual care use for managing COPD. It involves sending information through VA's Annie texting program to educate patients about virtual services available for their condition.

How Is the Trial Designed?

Group I: VC-OPTIONS Experimental Treatment 1 Intervention

Participants will be enrolled in the Annie texting VC-OPTIONS protocol

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Published Research Related to This Trial

A pilot study involving 10 COPD patients showed that a long-term telerehabilitation program, including home exercise training and telemonitoring, was feasible and maintained participant engagement over more than a year with no drop-outs.

The program led to a significant 27% reduction in COPD-related hospital costs, indicating potential benefits in healthcare utilization and positive feedback from participants about the service.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term telerehabilitation of COPD patients in their homes: interim results from a pilot study in Northern Norway. Zanaboni, P., Lien, LA., Hjalmarsen, A., et al.[2013]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05986214

Developing an Intervention to Optimize Virtual Care ... VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8894614/

Digital healthcare in COPD management: a narrative review ... Early therapy improves outcomes of exacerbations of chronic obstructive pulmonary disease. Am J Respir Crit Care Med 2004; 169: 1298–1303. [DOI] [PubMed] ...

3. mdedge.com mdedge.com/fedprac/article/272294/pulmonology/open-clinical-trials-patients-chronic-obstructive-pulmonary-disease

Open Clinical Trials for Patients With Chronic Obstructive ... This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to ...

4. publications.ersnet.org publications.ersnet.org/content/erj/51/2/1701531

Effectiveness versus efficacy trials in COPD: how study design ... Comparison of the Salford Lung Study with other chronic obstructive pulmonary disease efficacy randomised controlled trials on effectiveness and safety outcomes ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7005599/

Management of chronic obstructive pulmonary disease Notably, compared with LABA/ICS, LAMA/LABA combination therapy significantly reduced the rate of COPD exacerbations by 31% and 11%, respectively, in patients ...

6. emedicine.medscape.com emedicine.medscape.com/article/297664-treatment

Chronic Obstructive Pulmonary Disease (COPD) Treatment ... Two 12-week exercise/lung function studies provided supportive lung function data and contributed to safety data. Revefenacin.

7. sciencedirect.com sciencedirect.com/science/article/pii/S1555415522001246

Best Practice Management of Patients With Chronic ... The management of patients with COPD aims to minimize and control symptoms, prevent exacerbations, and improve quality of life.

8. jtd.amegroups.org jtd.amegroups.org/article/view/29614/html

Update on management of stable chronic obstructive ... Studies have shown that early respiratory rehabilitation following hospitalization for acute COPD exacerbation improves mortality [relative risk (RR) 0.58, 10% ...