Patient-Centred Perioperative Mobile Application

Cesarean Delivery Clinical Trial

Official title:

Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03746678
• Other study ID #: IWK1023201
• Status: Recruiting
• Start date: November 19, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: November 2018
• Source: IWK Health Centre
• Contact: Janny X Ke, MD
• Phone: (902) 470-7473
• Email: AnesthesiaResearch[@]iwk.nshealth.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: April 1, 2019
• Est. primary completion date: March 1, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cesarean Delivery

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Women's and Obstetric Anesthesia, IWK Health Centre	Halifax	Nova Scotia

Sponsors (1)

Lead Sponsor	Collaborator
IWK Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median number of information topics viewed per participant	Quantitative mobile application usage data	30 days
Primary	Median number of self-monitoring questionnaires completed per participant	Quantitative mobile application usage data	30 days
Primary	Median number of total visits to the mobile application per participant	Quantitative mobile application usage data	30 days
Primary	Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)	Quantitative responses from survey	2 to 3 weeks
Primary	Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery	Quantitative responses from survey	2 to 3 weeks
Primary	Percentage of self-monitoring questionnaires completed (out of 5) per participant	Quantitative mobile application usage data	30 days
Secondary	Which topics were viewed the most (rank by topic name and by postoperative day)	Quantitative mobile application usage data	30 days
Secondary	Which self-monitoring questionnaires were filled the most (rank by postoperative day number)	Quantitative mobile application usage data	30 days
Secondary	Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)	Quantitative mobile application usage data	30 days
Secondary	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	Quantitative mobile application usage data	30 days
Secondary	Time of the day patient filled out the questionnaire	Quantitative mobile application usage data	30 days
Secondary	Number of visits vs. postoperative day	Quantitative mobile application usage data	30 days
Secondary	Median duration (number of days starting from delivery date until the last day of visit) patient interacted with application.	Quantitative mobile application usage data	30 days
Secondary	% participant who responded "yes" to the question that C-Care App provided them with knowledge about Cesarean delivery and anesthesia	Quantitative responses from survey	2 to 3 weeks
Secondary	% participant who responded "yes" to the question that C-Care App provided them with knowledge about potential complications to monitor for	Quantitative responses from survey	2 to 3 weeks
Secondary	% participant who responded "yes" to the question that C-Care App provided them with knowledge about the recovery process after Cesarean delivery	Quantitative responses from survey	2 to 3 weeks
Secondary	Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?	Qualitative responses from survey	2 to 3 weeks
Secondary	If the patient did not use the mobile application, what were the reasons?	Qualitative responses from survey	2 to 3 weeks
Secondary	How could we make the mobile application more helpful for the patient?	Qualitative responses from survey	2 to 3 weeks
Secondary	What do patients think about the name of this App, "C-Care"? Do they have any other suggestions for our name/logo?	Qualitative responses from survey	2 to 3 weeks
Secondary	Any other comments and/or suggestions	Qualitative responses from survey	2 to 3 weeks

External Links

•   C-Care mobile application prototype