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Shoulder ArthroscopyNCT07725224

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

A study testing Smartphone App-based Digital Patient Instructions and Written Patient Instructions in people with Shoulder Arthroscopy, run by Johns Hopkins University.

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

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Shoulder Arthroscopy
What is being tested?
Smartphone App-based Digital Patient Instructions and Written Patient Instructions
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
100 participants
Where
No sites listed yet
Study dates
15 Nov 2026to 30 May 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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • scheduled for shoulder arthroscopy with participating surgeon

Who cannot join

  • -

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

Richard L Skolasky, Sc.D. contact

410-502-7975

rskolas1@jhmi.edu

About this study

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.

Read more

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.

Read the detailed description

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.

Being tested
Smartphone App-based Digital Patient Instructions, Written Patient Instructions

What participants receive

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

  • Smartphone App-based Digital Patient InstructionsBehavioural

    Smartphone App-based Digital Patient Instructions

  • Written Patient InstructionsBehavioural

    Written Patient Instructions

Study groups in NCT07725224
Study groupRoleWhat they receive
Written Patient InstructionsPlacebo comparatorWritten patient instructions
Receives: Behavioral: Written Patient Instructions
Smartphone App-based Digital Patient InstructionsExperimentalSmartphone app-based digital patient instructions
Receives: Behavioral: Smartphone App-based Digital Patient Instructions

What is being measured

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

  1. Information Retention

    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.

    Measured: 6 weeks, 6 months

Timeline

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

  1. First posted24 Jul 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion31 Mar 2028 (estimated)
  4. Study completion30 May 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
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
100 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07725224
Sponsor's protocol ID
IRB00475783
Status last verified
Sep 2026
First submitted
21 Jul 2026
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Smartphone App-based Digital Patient Instructions and Written Patient Instructions in people with Shoulder Arthroscopy, run by Johns Hopkins University.

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 1 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 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Richard L Skolasky, Sc.D. (410-502-7975, rskolas1@jhmi.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Information Retention (time frame: 6 weeks, 6 months). 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 17 Sep 2026.

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