- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT03746678
Patient-Centred Perioperative Mobile Application
Patient-Centered Perioperative Care Through Mobile Application: Patient Engagement Prospective Cohort Study in Elective Cesarean Delivery Patients
Přehled studie
Detailní popis
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.
Typ studie
Zápis (Očekávaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Janny X Ke, MD
- Telefonní číslo: (902) 470-7473
- E-mail: AnesthesiaResearch@iwk.nshealth.ca
Studijní záloha kontaktů
- Jméno: Ronald B George, MD FRCPC
- Telefonní číslo: (902) 470-7473
- E-mail: AnesthesiaResearch@iwk.nshealth.ca
Studijní místa
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Nova Scotia
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Halifax, Nova Scotia, Kanada, B3K 6R8
- Nábor
- Women's and Obstetric Anesthesia, IWK Health Centre
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Kontakt:
- Janny X Ke, MD
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Dílčí vyšetřovatel:
- Ronald B George, MD FRCPC
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Dílčí vyšetřovatel:
- Lori Wozney, PhD
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
---|---|
C-Care Mobile Application
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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.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Median number of information topics viewed per participant
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Median number of self-monitoring questionnaires completed per participant
Časové okno: 30 days
|
Quantitative mobile application usage data
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30 days
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Median number of total visits to the mobile application per participant
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Satisfaction score (scale of 0 to 10, 10 being extremely satisfied, 0 being not satisfied)
Časové okno: 2 to 3 weeks
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Quantitative responses from survey
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2 to 3 weeks
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Percentage of participants who would recommend the C-Care App to other women undergoing Cesarean delivery
Časové okno: 2 to 3 weeks
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Quantitative responses from survey
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2 to 3 weeks
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Percentage of self-monitoring questionnaires completed (out of 5) per participant
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
---|---|---|
Which topics were viewed the most (rank by topic name and by postoperative day)
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Which self-monitoring questionnaires were filled the most (rank by postoperative day number)
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Incidence of important potential anesthetic-related problems entered by the patient (pain, headache, weakness and numbness)
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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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
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Time of the day patient filled out the questionnaire
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Number of visits vs. postoperative day
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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Median duration (number of days starting from delivery date until the last day of visit) patient interacted with application.
Časové okno: 30 days
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Quantitative mobile application usage data
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30 days
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% participant who responded "yes" to the question that C-Care App provided them with knowledge about Cesarean delivery and anesthesia
Časové okno: 2 to 3 weeks
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Quantitative responses from survey
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2 to 3 weeks
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% participant who responded "yes" to the question that C-Care App provided them with knowledge about potential complications to monitor for
Časové okno: 2 to 3 weeks
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Quantitative responses from survey
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2 to 3 weeks
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% participant who responded "yes" to the question that C-Care App provided them with knowledge about the recovery process after Cesarean delivery
Časové okno: 2 to 3 weeks
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Quantitative responses from survey
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2 to 3 weeks
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Anything the patient wanted to change about this application, in terms of content, navigation, appearance, and overall experience?
Časové okno: 2 to 3 weeks
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Qualitative responses from survey
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2 to 3 weeks
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If the patient did not use the mobile application, what were the reasons?
Časové okno: 2 to 3 weeks
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Qualitative responses from survey
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2 to 3 weeks
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How could we make the mobile application more helpful for the patient?
Časové okno: 2 to 3 weeks
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Qualitative responses from survey
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2 to 3 weeks
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What do patients think about the name of this App, "C-Care"? Do they have any other suggestions for our name/logo?
Časové okno: 2 to 3 weeks
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Qualitative responses from survey
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2 to 3 weeks
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Any other comments and/or suggestions
Časové okno: 2 to 3 weeks
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Qualitative responses from survey
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2 to 3 weeks
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Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Očekávaný)
Primární dokončení (Očekávaný)
Dokončení studie (Očekávaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další identifikační čísla studie
- IWK1023201
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