Cesarean DeliveryNCT03746678
Patient-Centred Perioperative Mobile Application
An observational study of Cesarean Delivery, run by IWK Health Centre at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cesarean Delivery
- What is being tested?
- C-Care Mobile Application
- How many people
- 36 participants
- Where
- 1 siteCanada
- Study dates
- 19 Nov 2018to 1 Apr 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Elective Cesarean delivery patients at the IWK Health Centre
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Women's and Obstetric Anesthesia, IWK Health Centre
Halifax, Nova Scotia, B3K 6R8
Janny X Ke, MD
Ronald B George, MD FRCPC
About this study
Official title: 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.
Read the 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.
- Conditions
- Cesarean Delivery
- Being tested
- C-Care Mobile Application
- Keywords
- Cesarean delivery, Perioperative medicine, Mobile health
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
C-Care Mobile ApplicationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| C-Care Mobile Application | Not described Receives: Other: C-Care Mobile Application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Median number of information topics viewed per participant
Quantitative mobile application usage data
Measured: 30 days
Median number of self-monitoring questionnaires completed per participant
Quantitative mobile application usage data
Measured: 30 days
Median number of total visits to the mobile application per participant
Quantitative mobile application usage data
Measured: 30 days
Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)
Quantitative responses from survey
Measured: 2 to 3 weeks
Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery
Quantitative responses from survey
Measured: 2 to 3 weeks
Percentage of self-monitoring questionnaires completed (out of 5) per participant
Quantitative mobile application usage data
Measured: 30 days
Secondary outcomes (15)
Which topics were viewed the most (rank by topic name and by postoperative day)
Quantitative mobile application usage data
Measured: 30 days
Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
Quantitative mobile application usage data
Measured: 30 days
Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)
Quantitative mobile application usage data
Measured: 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
Quantitative mobile application usage data
Measured: 30 days
Time of the day patient filled out the questionnaire
Quantitative mobile application usage data
Measured: 30 days
Number of visits vs. postoperative day
Quantitative mobile application usage data
Measured: 30 days
Median duration (number of days starting from delivery date until the last day of visit) patient interacted with application.
Quantitative mobile application usage data
Measured: 30 days
% participant who responded "yes" to the question that C-Care App provided them with knowledge about Cesarean delivery and anesthesia
Quantitative responses from survey
Measured: 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
Quantitative responses from survey
Measured: 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
Quantitative responses from survey
Measured: 2 to 3 weeks
Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?
Qualitative responses from survey
Measured: 2 to 3 weeks
If the patient did not use the mobile application, what were the reasons?
Qualitative responses from survey
Measured: 2 to 3 weeks
How could we make the mobile application more helpful for the patient?
Qualitative responses from survey
Measured: 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?
Qualitative responses from survey
Measured: 2 to 3 weeks
Any other comments and/or suggestions
Qualitative responses from survey
Measured: 2 to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2018
- Study start19 Nov 2018 (estimated)
- Primary completion1 Mar 2019 (estimated)
- Study completion1 Apr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cesarean DeliveryStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03746678
- Sponsor's protocol ID
- IWK1023201
- Status last verified
- Nov 2018
- First submitted
- 5 Nov 2018
- Last updated
- 20 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ke JXC, George RB, Wozney L, Munro A. Perioperative mobile application for mothers undergoing Cesarean delivery: a prospective cohort study on patient engagement. Can J Anaesth. 2021 Apr;68(4):505-513. doi: 10.1007/s12630-020-01907-x. Epub 2021 Jan 9.
PubMed 33420678
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
- ClinicalTrials.gov ID
- NCT03746678
- Acronym / sponsor ID
- IWK1023201
- Conditions
- Cesarean Delivery
- Keywords
- Cesarean delivery, Perioperative medicine, Mobile health
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Study start
- 19 Nov 2018 (estimated)
- Primary completion
- 1 Mar 2019 (estimated)
- Study completion
- 1 Apr 2019 (estimated)
- First posted
- 20 Nov 2018 (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.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| C-Care Mobile Application | – | Other: C-Care Mobile Application |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Elective Cesarean delivery patients at the IWK Health Centre
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (1 listed)
- 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.
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 |
|---|---|---|
| C-Care Mobile ApplicationC-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. | Other | C-Care Mobile Application |
Primary outcome
Median number of information topics viewed per participant
Time frame: 30 days
Quantitative mobile application usage data
Median number of self-monitoring questionnaires completed per participant
Time frame: 30 days
Quantitative mobile application usage data
Median number of total visits to the mobile application per participant
Time frame: 30 days
Quantitative mobile application usage data
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
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
Percentage of self-monitoring questionnaires completed (out of 5) per participant
Time frame: 30 days
Quantitative mobile application usage data
15 secondary outcomes
Which topics were viewed the most (rank by topic name and by postoperative day)
Time frame: 30 days
Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
Time frame: 30 days
Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)
Time frame: 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
Time of the day patient filled out the questionnaire
Time frame: 30 days
Number of visits vs. postoperative day
Time frame: 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
% 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
% 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
% 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
Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?
Time frame: 2 to 3 weeks
If the patient did not use the mobile application, what were the reasons?
Time frame: 2 to 3 weeks
How could we make the mobile application more helpful for the patient?
Time frame: 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
Any other comments and/or suggestions
Time frame: 2 to 3 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Nov 2018.
- Derived from this study: PubMed 33420678Ke JXC, George RB, Wozney L, Munro A. Perioperative mobile application for mothers undergoing Cesarean delivery: a prospective cohort study on patient engagement. Can J Anaesth. 2021 Apr;68(4):505-513. doi: 10.1007/s12630-020-01907-x. Epub 2021 Jan 9.
- C-Care mobile application prototypeLink provided by the sponsor.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cesarean Delivery, run by IWK Health Centre at 1 site in Canada.
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 8 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: status not confirmed, as of the sponsor's last update on 20 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Janny X Ke, MD ((902) 470-7473, AnesthesiaResearch@iwk.nshealth.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Median number of information topics viewed per participant (time frame: 30 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03746678, which also lists 1 linked publication.
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 20 Nov 2018.