NCT03746678

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
36

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 5, 2018

Completed
14 days until next milestone

Study Start

First participant enrolled

November 19, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 20, 2018

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2019

Completed
Last Updated

November 20, 2018

Status Verified

November 1, 2018

Enrollment Period

3 months

First QC Date

November 5, 2018

Last Update Submit

November 19, 2018

Conditions

Keywords

Cesarean deliveryPerioperative medicineMobile health

Outcome Measures

Primary Outcomes (6)

  • Median number of information topics viewed per participant

    Quantitative mobile application usage data

    30 days

  • Median number of self-monitoring questionnaires completed per participant

    Quantitative mobile application usage data

    30 days

  • Median number of total visits to the mobile application per participant

    Quantitative mobile application usage data

    30 days

  • Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)

    Quantitative responses from survey

    2 to 3 weeks

  • Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery

    Quantitative responses from survey

    2 to 3 weeks

  • Percentage of self-monitoring questionnaires completed (out of 5) per participant

    Quantitative mobile application usage data

    30 days

Secondary Outcomes (15)

  • Which topics were viewed the most (rank by topic name and by postoperative day)

    30 days

  • Which self-monitoring questionnaires were filled the most (rank by postoperative day number)

    30 days

  • Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)

    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

    30 days

  • Time of the day patient filled out the questionnaire

    30 days

  • +10 more secondary outcomes

Study Arms (1)

C-Care Mobile Application

Other: C-Care Mobile Application

Interventions

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.

C-Care Mobile Application

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Elective Cesarean delivery patients at the IWK Health Centre

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's and Obstetric Anesthesia, IWK Health Centre

Halifax, Nova Scotia, B3K 6R8, Canada

RECRUITING

Related Publications (1)

  • 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.

Related Links

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2018

First Posted

November 20, 2018

Study Start

November 19, 2018

Primary Completion

March 1, 2019

Study Completion

April 1, 2019

Last Updated

November 20, 2018

Record last verified: 2018-11

Data Sharing

IPD Sharing
Will not share

Locations