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Sviluppo di un intervento per ottimizzare l'adozione di cure virtuali per la gestione della BPCO (VC-OPTIONS)

24 settembre 2026 aggiornato da: VA Office of Research and Development

Sviluppo di un intervento per ottimizzare l'adozione di cure virtuali per la gestione della BPCO (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.

Panoramica dello studio

Stato

Non ancora reclutamento

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Interventistico

Iscrizione (Stimato)

40

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

    • Massachusetts
      • Bedford, Massachusetts, Stati Uniti, 01730-1114
        • VA Bedford HealthCare System, Bedford, MA
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Stephanie Robinson, PhD
      • Boston, Massachusetts, Stati Uniti, 02130-4817

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

40 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

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

Exclusion Criteria:

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: N / A
  • Modello interventistico: Assegnazione di gruppo singolo
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: VC-OPTIONS

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

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

Altri nomi:
  • Intervento di sms

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility
Lasso di tempo: 12 Weeks

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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Acceptability
Lasso di tempo: 12 Weeks

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.

12 Weeks
Appropriateness
Lasso di tempo: 12 Weeks

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.

12 Weeks
Awareness of Virtual Care
Lasso di tempo: 12 Weeks

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?

12 Weeks
Intention to Adopt Virtual Care
Lasso di tempo: Baseline and 12 weeks

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?

Baseline and 12 weeks
Intent to Communicate about Virtual Care
Lasso di tempo: Baseline and 12 weeks

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."

Baseline and 12 weeks
Impact of Chronic Obstructive Pulmonary Disease (COPD) Management
Lasso di tempo: 12 weeks

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.

12 weeks

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Investigatore principale: Stephanie Robinson, PhD, VA Bedford HealthCare System, Bedford, MA

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

2 settembre 2027

Completamento primario (Stimato)

31 agosto 2028

Completamento dello studio (Stimato)

31 agosto 2028

Date di iscrizione allo studio

Primo inviato

31 luglio 2023

Primo inviato che soddisfa i criteri di controllo qualità

9 agosto 2023

Primo Inserito (Effettivo)

14 agosto 2023

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

29 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

24 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • CDX 23-001
  • CDA 21-187 (Altro numero di sovvenzione/finanziamento: VA HSR&D)
  • 1IK2HX003532-01A2 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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