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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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.
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.
- Conditions
- Shoulder Arthroscopy
- 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 group | Role | What they receive |
|---|---|---|
| Written Patient Instructions | Placebo comparator | Written patient instructions Receives: Behavioral: Written Patient Instructions |
| Smartphone App-based Digital Patient Instructions | Experimental | Smartphone 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.
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.
- First posted24 Jul 2026
- Study start15 Nov 2026 (estimated)
- Primary completion31 Mar 2028 (estimated)
- Study completion30 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder ArthroscopyStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Frontive
- Responsible party
- Sponsor
- Investigators
- Richard Skolasky, Sc.D., Principal investigator, Johns Hopkins University
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of a Smartphone App to Support Pre- and Post-Surgical Preparedness and to Improve Clinical Outcomes in Patients Undergoing Shoulder Arthroscopy
- ClinicalTrials.gov ID
- NCT07725224
- Acronym / sponsor ID
- IRB00475783
- Conditions
- Shoulder Arthroscopy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Frontive
- Study start
- 15 Nov 2026 (estimated)
- Primary completion
- 31 Mar 2028 (estimated)
- Study completion
- 30 May 2028 (estimated)
- First posted
- 24 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Written Patient Instructions | Placebo comparator | Behavioral: Written Patient InstructionsWritten patient instructions |
| Smartphone App-based Digital Patient Instructions | Experimental | Behavioral: Smartphone App-based Digital Patient InstructionsSmartphone app-based digital patient instructions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- scheduled for shoulder arthroscopy with participating surgeon
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone App-based Digital Patient InstructionsSmartphone App-based Digital Patient Instructions | Behavioural | Smartphone App-based Digital Patient Instructions |
| Written Patient InstructionsWritten Patient Instructions | Behavioural | Written Patient Instructions |
Primary outcome
Information Retention
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Richard Skolasky, Sc.D. principal investigator
Johns Hopkins University
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.