- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07725224
Use of a Smartphone App to Support Pre- and Post-Surgical Preparedness and to Improve Clinical Outcomes in Patients Undergoing Shoulder Arthroscopy
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.
연구 개요
상태
정황
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Richard L Skolasky, Sc.D.
- 전화번호: 410-502-7975
- 이메일: rskolas1@jhmi.edu
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- scheduled for shoulder arthroscopy with participating surgeon
Exclusion Criteria:
-
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: Written Patient Instructions
Written patient instructions
|
Written Patient Instructions
|
|
실험적: Smartphone App-based Digital Patient Instructions
Smartphone app-based digital patient instructions
|
Smartphone App-based Digital Patient Instructions
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Information Retention
기간: 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
|
공동 작업자 및 조사자
협력자
수사관
- 수석 연구원: Richard Skolasky, Sc.D., Johns Hopkins University
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- IRB00475783
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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어깨 관절경에 대한 임상 시험
-
University Hospital, Angers모병
Written Patient Instructions에 대한 임상 시험
-
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-
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-
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