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Chronic Obstructive Pulmonary DiseaseVC-OPTIONSNCT05986214

Developing an Intervention to Optimize Virtual Care Adoption for COPD Management

A study testing VC-OPTIONS in people with Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 2 sites in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Chronic Obstructive Pulmonary Disease
What is being tested?
VC-OPTIONS
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesUnited States
Study dates
2 Sep 2027to 31 Aug 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • VHA user
  • US Veteran
  • Chronic obstructive pulmonary disease (COPD) diagnosis
  • The ability to speak and understand English
  • Own a text-enabled phone

Who cannot join

  • Prior participation in preparatory research for the development of the intervention

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Stephanie Robinson, PhD contact

(781) 687-4766

stephanie.robinson5@va.gov

Saige M Calkins, MA BA contact

(781) 687-4414 ext. 4414

saige.calkins@va.gov

United States2 sites
  • VA Bedford HealthCare System, Bedford, MA

    Bedford, Massachusetts, 01730-1114

    Stephanie Robinson, PhD, (781) 687-4766, stephanie.robinson5@va.gov

    Saige M Calkins, MA BA, (781) 687-4414 ext. 4414, saige.calkins@va.gov

  • VA Boston Healthcare System Jamaica Plain Campus, Jamaica Plain, MA

    Boston, Massachusetts, 02130-4817

    Renda Wiener, MD, renda.wiener@va.gov

    Marilyn Moy, MD, Marilyn.Moy@va.gov

Other trials in United States

About this study

Official title: Developing an Intervention to Optimize Virtual Care Adoption for COPD Management (CDA 21-187)

VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This feasibility trial will pilot the VC-OPTIONS implementation strategy to assess feasibility and acceptability and gather preliminary effectiveness data to inform a larger hybrid effectiveness-implementation trial. The core component of VC-OPTIONS will be the provision of information via VA's Annie texting program to empower patients with knowledge about the array of VC services and how they can be used to support COPD management. It is hypothesized that this strategy will be acceptable and feasible. This work will improve patient and team awareness of and communication about VC services, and support patient access to VC services for COPD management.

Read the detailed description

VA is a leader in virtual care (VC), including the patient portal, mobile apps, and telehealth programs. VC has great utility for managing chronic conditions like chronic obstructive pulmonary disease (COPD). However, adoption of many VC services has been slow. Lack of awareness about these services is one of the most prominent patient- and healthcare team-facing barriers to adopting VC. This study will develop, refine, and pilot a stakeholder-informed multicomponent implementation strategy to support adoption of VC, referred to as VC-OPTIONS (Virtual Care for Chronic Obstructive Pulmonary Disease Adoption Support). This single-arm pilot will assess the feasibility and acceptability of VC-OPTIONS, as well as engagement and preliminary effectiveness specific to VC adoption, such as change in patient awareness of VC services. The investigators hypothesize that developing educational content about VC that can be delivered via text messaging will be an effective way to empower Veterans with knowledge and support them in their decision to adopt VC if they are interested.

Setting and design.

This feasibility pilot will be conducted at the VA Bedford and/or Boston Healthcare Systems. This pilot study will use quantitative data to assess patient and team perceptions of feasibility and acceptability, and preliminary effectiveness of the intervention. VC-OPTIONS will include patient- and team-facing strategies. The core component will be the delivery of educational content about VC for COPD via Annie text messaging. Other patient- and healthcare team-facing strategies will be refined in prior, preparatory aims.

Patient level. 40 eligible and interested Veterans will be assigned to the core patient-facing implementation strategy, the Annie texting protocol. Preparatory work will shape final length of protocol, content, and frequency of messages. The texting protocol as currently envisioned will span 12 weeks (1 module [Appendix 5] with up to 5 messages per week, and 2 messages every 4 weeks that ask about behavioral intention). Participants will receive compensation for initial baseline assessments and additional compensation after completion of the follow-up assessments.

Team-level. Pre-implementation meetings with local clinical team stakeholders (e.g., leadership, clinical team members, local telehealth/connected care coordinators) will be held to discuss site-level needs and contextual factors. Potential team-facing strategy components, developed during preparatory aims, will be presented and discussed to reach consensus and finalize the team-facing strategy components that are tailored to the site-level needs and resources.

Data collection. Patient-level. Recruitment procedures will be evaluated to inform a subsequent larger trial by examining how many potential participants agreed to participate in the intervention (feasibility and acceptability), and documenting reasons Veterans declined to participate. Participants will complete a baseline survey in person or over the phone to gather participant characteristics, VC awareness, current use of VC, and intent to use VC. Using Annie's two-way texting feature and dashboard, objective data will be collected on participant engagement during the protocol (i.e., how frequently participants respond to the texts, which patients received which modules, and completion rates). Engagement will also be assessed via survey at the post-evaluation. After completion of the texting protocol and clinical visit, data will be obtained via survey on the feasibility and acceptability of the core implementation component using the Feasibility of Intervention, Acceptability of Intervention, and Intervention Appropriateness measures. Preliminary effectiveness data will be gathered via surveys and clinical chart review on participants' awareness of VC, intention to adopt one or more VC options, intention to discuss VC with their clinical team, occurrence of patient-team communication about VC, and impact on COPD management.

Team-level. Clinical team perceptions of feasibility and acceptability will be measured quantitatively, such as through a brief survey to clinical team members who were exposed to the implementation components (e.g., those who attended the educational meetings, those who participated in clinical visits with participants who were enrolled in the texting protocol). Engagement will be measured by examining attendance of educational meetings. Preliminary effectiveness outcomes data will also be collected, including survey and chart-review to identify occurrence of conversations with patients about VC services (anticipated primary outcome of future IIR) and referrals to the Virtual Health Resource Centers or telehealth services and surveys to evaluate awareness of VC services before/after strategy deployment.

Data analysis. Summary statistics will be used to examine measurements and assess for perceptions of feasibility, acceptability, and preliminary effectiveness of the implementation strategy. The strategy components (the texting protocol, recruitment, and data collection procedures) will further be refined based on what is learned. Inferential analyses (paired t-tests or Wilcoxon signed rank tests) will be used to estimate effect sizes of changes between pre/post timepoints within individual participant. This feasibility pilot is not intended or powered to detect statistically significant changes in outcomes. Additionally, this pilot with no prospective control arm cannot definitively ascertain whether VC-OPTIONS causes leads to changes in effectiveness. These preliminary analyses seek to inform the design and generate effect size estimates.

Being tested
VC-OPTIONS
Keywords
Pulmonary Disease, Chronic Obstructive, Telemedicine, Text Messaging, Implementation Science, Community-Based Participatory Research
Medical subject headings
Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VC-OPTIONSOther

    Also called Texting Intervention

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

Study groups in NCT05986214
Study groupRoleWhat they receive
VC-OPTIONSExperimentalParticipants will be enrolled in the Annie texting VC-OPTIONS protocol
Receives: Other: VC-OPTIONS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Feasibility

    The feasibility of the core implementation component will be assessed with the Feasibility of Intervention Measure (FIM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): I can see other Veterans receiving these messages; I was able to respond to the text messages; texting with Annie was easy; the amount of messages I received from Annie was just right.

    Measured: 12 Weeks

Secondary outcomes (6)
  1. Acceptability

    The acceptability of the core implementation component will be assessed with the Acceptability of Intervention Measure (AIM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): I approved of the text messages I received; the text messages I received were appealing to me; I liked receiving and responding to the text messages I received; I welcomed the text messages I received.

    Measured: 12 Weeks

  2. Appropriateness

    The appropriateness of the core implementation component will be assessed with the Intervention Appropriateness Measure (IAM). This is a publicly available, psychometrically sound scale designed to be used in pilot studies as an indicator of implementation success. Participants will be asked to indicate the extent to which they agree with the following statements on a scale from 1 (completely disagree) to 5 (completely agree): the text messages were fitting; the text messages were suitable, the text messages were applicable to me; the text messages were a good match with my COPD management needs.

    Measured: 12 Weeks

  3. Awareness of Virtual Care

    Change between baseline and 12 weeks in awareness of Virtual Care services will be assessed via survey, pre and post intervention, through the following question: which of the following VA services are you aware of?

    Measured: 12 Weeks

  4. Intention to Adopt Virtual Care

    Change between baseline and 12 weeks in awareness of Virtual Care services will be assessed via survey through the following question: which of the following VA services are you interested in trying out?

    Measured: Baseline and 12 weeks

  5. Intent to Communicate about Virtual Care

    Change between baseline and 12 weeks will assess intent to communicate about Virtual Care from baseline to post-intervention (12 weeks) through the following questions: how interested are you in discussing these different services with your healthcare team; and how prepared do you feel to discuss these different services with your healthcare team? Participants will indicate on a 4-point scale from "not very" to "very."

    Measured: Baseline and 12 weeks

  6. Impact of Chronic Obstructive Pulmonary Disease (COPD) Management

    Participants will be asked to describe via free text any impacts participation in this study has had on how they use technology to manage their COPD. This will be qualitative data.

    Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2023
  2. Study start2 Sep 2027 (estimated)
  3. Primary completion31 Aug 2028 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
All patient participants will all be assigned to the VC-OPTIONS implementation strategy
Masking
None (open label)
Enrolment
40 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05986214
Sponsor's protocol ID
CDX 23-001
Other IDs
1IK2HX003532-01A2, CDA 21-187
Acronym
VC-OPTIONS
Status last verified
Sep 2026
First submitted
31 Jul 2023
Last updated
29 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: There is not a plan to make IPD available. Data will be used by the research team only to inform manuscripts and future grant submissions.

Questions about this trial

What is this clinical trial studying?

A study testing VC-OPTIONS in people with Chronic Obstructive Pulmonary Disease, run by VA Office of Research and Development at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Stephanie Robinson, PhD ((781) 687-4766, stephanie.robinson5@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility (time frame: 12 Weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026; AzTrials last refreshed its copy on 28 Oct 2026.

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