Patient-Centred Perioperative Mobile Application
November 19, 2018 updated by: IWK Health Centre
Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
With increasingly more complex surgical patients and the trend toward decreased hospital stay after operations, continuity of care and prompt management of symptoms and side effects perioperatively are ever more crucial.
The investigators' goal is to improve perioperative care with a patient-centred mobile application, starting with a pilot in patients undergoing elective Cesarean delivery.
The investigators have completed a research study where they created a prototype based on feedback from patients and anesthesiologists.
In this study, the investigators would like to learn about how patients use our mobile application after delivery and how the mobile application can be integrated into daily practice.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Observational
Enrollment (Anticipated)
36
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Nova Scotia
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Halifax, Nova Scotia, Canada, B3K 6R8
- Recruiting
- Women's and Obstetric Anesthesia, IWK Health Centre
-
Contact:
- Janny X Ke, MD
-
Sub-Investigator:
- Ronald B George, MD FRCPC
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Sub-Investigator:
- Lori Wozney, PhD
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
Elective Cesarean delivery patients at the IWK Health Centre
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Median number of information topics viewed per participant
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Median number of self-monitoring questionnaires completed per participant
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Median number of total visits to the mobile application per participant
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)
Time Frame: 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
Time Frame: 2 to 3 weeks
|
Quantitative responses from survey
|
2 to 3 weeks
|
|
Percentage of self-monitoring questionnaires completed (out of 5) per participant
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Which topics were viewed the most (rank by topic name and by postoperative day)
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
Time Frame: 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)
Time Frame: 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
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Time of the day patient filled out the questionnaire
Time Frame: 30 days
|
Quantitative mobile application usage data
|
30 days
|
|
Number of visits vs. postoperative day
Time Frame: 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.
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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?
Time Frame: 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?
Time Frame: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
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How could we make the mobile application more helpful for the patient?
Time Frame: 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?
Time Frame: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
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Any other comments and/or suggestions
Time Frame: 2 to 3 weeks
|
Qualitative responses from survey
|
2 to 3 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 19, 2018
Primary Completion (Anticipated)
March 1, 2019
Study Completion (Anticipated)
April 1, 2019
Study Registration Dates
First Submitted
November 5, 2018
First Submitted That Met QC Criteria
November 19, 2018
First Posted (Actual)
November 20, 2018
Study Record Updates
Last Update Posted (Actual)
November 20, 2018
Last Update Submitted That Met QC Criteria
November 19, 2018
Last Verified
November 1, 2018
More Information
Terms related to this study
Other Study ID Numbers
- IWK1023201
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.