- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03746678
Patient-Centred Perioperative Mobile Application
Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
연구 개요
상세 설명
The objective of this cohort study is to build the mobile application and evaluate its feasibility in providing patient education and reminders for self-monitoring for cesarean delivery patients. The investigators will measure the extent of patient engagement with our application through in-app usage data, as well as receive quantitative and qualitative feedback regarding feasibility. By understanding user behavior and needs through questionnaires and application usage data, the investigators could design more effective and tailored interventions for patients. Results of this study will help further development and implementation of an interdisciplinary mobile monitoring and communication platform for perioperative care.
This study is funded by the Dalhousie University Department of Anesthesia, Pain Management & Perioperative Medicine.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Janny X Ke, MD
- 전화번호: (902) 470-7473
- 이메일: AnesthesiaResearch@iwk.nshealth.ca
연구 연락처 백업
- 이름: Ronald B George, MD FRCPC
- 전화번호: (902) 470-7473
- 이메일: AnesthesiaResearch@iwk.nshealth.ca
연구 장소
-
-
Nova Scotia
-
Halifax, Nova Scotia, 캐나다, B3K 6R8
- 모병
- Women's and Obstetric Anesthesia, IWK Health Centre
-
연락하다:
- Janny X Ke, MD
-
부수사관:
- Ronald B George, MD FRCPC
-
부수사관:
- Lori Wozney, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
Part 1 (screened by asking nurse)
- Patient scheduled for elective Cesarean delivery
- Age equal or greater than 18
- American Society of Anesthesiologists (ASA) Physical Status I-III (i.e. not in life-threatening situation)
Part 2 (screened in person)
- Possesses an iOS Smartphone with active data plan and access to WiFi, and self-reported use of it on a regular basis (at this stage in development, the mobile application prototype is only available on iOS)
- Self-reported proficiency with Smartphone and mobile applications
- Reported fluency in English
Exclusion Criteria:
Self-reported physical or psychiatric condition that may impair the ability to use the mobile application, answer questionnaires and surveys, and/or provide insights representative of the general population, such as blindness, under current influence of recreational drugs or alcohol.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
C-Care Mobile Application
|
C-care is a mobile application developed based on previous research at the IWK Health Centre.
It contains topics relevant to Cesarean delivery and the recovery process, which the patient could access at anytime.
Patient engagement with the application will be monitored anonymously for 30 days after delivery.
On days one to five after delivery, patients will receive a short self-monitoring questionnaire (approximately 1 minute).
At the end of two weeks (14 days), patients will complete an online survey regarding overall satisfaction, potential impact on care, usability and feasibility problems.
At any point during the study, patients can email us to report any problems with the application.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Median number of information topics viewed per participant
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Median number of self-monitoring questionnaires completed per participant
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Median number of total visits to the mobile application per participant
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)
기간: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery
기간: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
Percentage of self-monitoring questionnaires completed (out of 5) per participant
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Which topics were viewed the most (rank by topic name and by postoperative day)
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Time of the day patient visited site (scatter plot of Nova Scotia time vs. # visits) - one visit = at least one interaction within app, e.g. opening a topic, navigating within app
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Time of the day patient filled out the questionnaire
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Number of visits vs. postoperative day
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Median duration (number of days starting from delivery date until the last day of visit) patient interacted with application.
기간: 30 days
|
Quantitative mobile application usage data
|
30 days
|
% participant who responded "yes" to the question that C-Care App provided them with knowledge about Cesarean delivery and anesthesia
기간: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
% participant who responded "yes" to the question that C-Care App provided them with knowledge about potential complications to monitor for
기간: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
% participant who responded "yes" to the question that C-Care App provided them with knowledge about the recovery process after Cesarean delivery
기간: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?
기간: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
If the patient did not use the mobile application, what were the reasons?
기간: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
How could we make the mobile application more helpful for the patient?
기간: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
What do patients think about the name of this App, "C-Care"? Do they have any other suggestions for our name/logo?
기간: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
Any other comments and/or suggestions
기간: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
C-Care Mobile Application에 대한 임상 시험
-
KU Leuven완전한
-
Zealand University HospitalUniversity of Copenhagen; Steno Diabetes Center Copenhagen; Holbaek Sygehus모병