NCT05986214

Brief 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. 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.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable chronic-obstructive-pulmonary-disease

Timeline
24mo left

Started Sep 2026

Typical duration for not_applicable chronic-obstructive-pulmonary-disease

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2023

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
3.1 years until next milestone

Study Start

First participant enrolled

September 1, 2026

Expected
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2027

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2028

Last Updated

March 16, 2026

Status Verified

March 1, 2026

Enrollment Period

12 months

First QC Date

July 31, 2023

Last Update Submit

March 12, 2026

Conditions

Keywords

Pulmonary Disease, Chronic ObstructiveTelemedicineText MessagingImplementation ScienceCommunity-Based Participatory Research

Outcome Measures

Primary Outcomes (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.

    12 Weeks

Secondary Outcomes (6)

  • Acceptability

    12 Weeks

  • Appropriateness

    12 Weeks

  • Awareness of Virtual Care

    12 Weeks

  • Intention to Adopt Virtual Care

    Baseline and 12 weeks

  • Intent to Communicate about Virtual Care

    Baseline and 12 weeks

  • +1 more secondary outcomes

Study Arms (1)

VC-OPTIONS

EXPERIMENTAL

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

Other: VC-OPTIONS

Interventions

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

Also known as: Texting Intervention
VC-OPTIONS

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • VHA user
  • US Veteran
  • COPD diagnosis
  • the ability to speak and understand English
  • own a text-enabled phone

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Bedford HealthCare System, Bedford, MA

Bedford, Massachusetts, 01730-1114, United States

Location

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

Boston, Massachusetts, 02130-4817, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Stephanie Robinson, PhD

    VA Bedford HealthCare System, Bedford, MA

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stephanie Robinson, PhD

CONTACT

Saige M Calkins, MA BA

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: All patient participants will all be assigned to the VC-OPTIONS implementation strategy
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 31, 2023

First Posted

August 14, 2023

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2028

Last Updated

March 16, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

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.

Locations