Questa pagina è stata tradotta automaticamente e l'accuratezza della traduzione non è garantita. Si prega di fare riferimento al Versione inglese per un testo di partenza.

Use of a Smartphone App to Support Pre- and Post-Surgical Preparedness and to Improve Clinical Outcomes in Patients Undergoing Shoulder Arthroscopy

21 luglio 2026 aggiornato da: Johns Hopkins University

This study is testing whether a smartphone app can help patients better follow instructions before and after shoulder surgery, compared to the usual paper instructions.

People from all backgrounds sometimes have trouble understanding or remembering everything needed to prepare for surgery and recover safely - things like when to stop certain medications, how to shower with a special soap before surgery, or how to care for a wound afterward. Missing these steps can lead to surgery being delayed or canceled, or to problems during recovery. These difficulties can be greater for patients facing barriers such as limited health information, language differences, or lack of support at home.

This study includes adults having planned shoulder arthroscopy (a type of shoulder surgery) at Johns Hopkins. Participants will be randomly assigned to one of two groups: one will receive the standard printed instructions currently used in clinic, and the other will receive the same instructions through an app on the smartphone. The app also pulls basic information from the patient's electronic health record - surgery type, date, surgeon, and medications - so instructions can be tailored to each patient. Patients using the app confirm when each step is completed, such as taking a medication or showering before surgery, and also report on how the participant is doing after surgery, which is shared with the patient's care team.

The goal is to see whether the app helps patients follow instructions more closely, improves the patient's experience and recovery, and reduces the workload on nurses and clinic staff - particularly for patients who face more barriers to care.

Panoramica dello studio

Descrizione dettagliata

Disparities in surgical outcomes between marginalized and non-marginalized populations are well documented and are driven in part by systemic factors such as provider bias, limited health literacy, and inadequate patient support. These factors contribute to poor adherence to pre- and post-operative instructions, which in turn is associated with worse clinical outcomes, higher rates of day-of-surgery delay or cancellation, and increased healthcare costs, disproportionately affecting underserved patients. Patients with fewer resources often face additional difficulty navigating complex perioperative instructions without adequate guidance or support.

A smartphone application has been developed to improve patient adherence to complex medical instructions, with a particular focus on perioperative care. The application digitizes patient education materials that are otherwise delivered on paper, converting instructions into discrete, trackable tasks that patients acknowledge as completed. The application is linked, on a read-only basis, to the patient's electronic health record (EHR) to retrieve procedure type, procedure date, treating physician, and current medications, allowing instructions to be lightly personalized without requiring manual data entry by clinical staff. With the exception of medication information, the content delivered through the application is the same as that currently provided on paper. Prior non-research deployments of the application have suggested it may improve adherence and reduce administrative and clinical staff burden, though this has not been formally evaluated in a controlled study.

This is a proof-of-concept, randomized clinical trial designed to evaluate the feasibility, acceptability, and preliminary effectiveness of smartphone-based patient education compared to standard paper-based patient education in adults undergoing planned shoulder arthroscopy.

The primary objective is to assess the feasibility and acceptability of implementing the smartphone application in this clinical population, evaluated through study-tracked implementation metrics (e.g., enrollment, retention, app engagement) and participant self-report.

Secondary objectives are to: (1) evaluate whether the application, by delivering EHR-linked, updated patient instructions, improves patient adherence to pre- and post-operative instructions, assessed via application usage data and self-report; (2) evaluate whether the application improves patient experience and health outcomes, assessed via self-reported satisfaction and patient-reported outcome measures; and (3) evaluate whether the application reduces burden on nursing and office staff, assessed through post-study staff interviews.

Approximately 100 adults scheduled for planned shoulder arthroscopy will be recruited. Potentially eligible patients will be identified from the clinic schedule by the research team and contacted by email in advance of the scheduled clinic visit to describe the study and provide research team contact information for those interested in learning more. At the scheduled visit, the treating surgeon will confirm surgical candidacy as a clinical decision, separate from the decision of whether the patient wishes to participate in the research study. For patients expressing interest, the research team will describe the study in detail, answer questions, and the treating surgeon will obtain informed consent.

Enrolled participants will be randomized to one of two arms: (1) standard paper-based patient instructions, reflecting current clinical practice, or (2) the same instructional content delivered through a smartphone application. Participants randomized to the application arm will be provided a link to install the application on the participant's personal smartphone (Apple or Android operating system) and will register within the application to enable linkage to EHR, with assistance from a research coordinator as needed. These participants will be instructed to log into the application daily to review pre- and post-operative instructions and confirm completion of individual tasks (for example, pre-operative antiseptic showers, medication holds, fasting instructions, daily medications, and post-operative wound care), with prioritization given to actions associated with risk of day-of-surgery delay or cancellation and post-operative complications. The application will also collect patient-reported outcome measures, which will be shared with the treatment team through a separate portal. Participants will be instructed to contact the treating surgeon's office for clinical questions and the research team for study-related questions throughout study participation.

Tipo di studio

Interventistico

Iscrizione (Stimato)

100

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

  • Nome: Richard L Skolasky, Sc.D.
  • Numero di telefono: 410-502-7975
  • Email: rskolas1@jhmi.edu

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

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • scheduled for shoulder arthroscopy with participating surgeon

Exclusion Criteria:

-

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: Altro
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Written Patient Instructions
Written patient instructions
Written Patient Instructions
Sperimentale: Smartphone App-based Digital Patient Instructions
Smartphone app-based digital patient instructions
Smartphone App-based Digital Patient Instructions

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Information Retention
Lasso di tempo: 6 weeks, 6 months
Self-report of retention of patient instruction information. Participants will rate their retention of key information using a 6 item scale with a score range from 0 - 12 with higher numbers indicating greater retention.
6 weeks, 6 months

Collaboratori e investigatori

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

Collaboratori

Investigatori

  • Investigatore principale: Richard Skolasky, Sc.D., Johns Hopkins University

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)

15 settembre 2026

Completamento primario (Stimato)

31 gennaio 2028

Completamento dello studio (Stimato)

31 marzo 2028

Date di iscrizione allo studio

Primo inviato

21 luglio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 luglio 2026

Primo Inserito (Effettivo)

24 luglio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

24 luglio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

21 luglio 2026

Ultimo verificato

1 luglio 2026

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • IRB00475783

Piano per i dati dei singoli partecipanti (IPD)

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

NO

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

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 .

Prove cliniche su Written Patient Instructions

Sottoscrivi