Ignite Creation Date:
2024-05-06 @ 7:55 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06188247
Status:
RECRUITING
Last Update Posted:
2024-01-05
First Post:
2023-12-18
Brief Title:
Pilot-trial Testing Remote Sleep Apnea Evaluation in Patients With Atrial Fibrillation
Sponsor:
Herlev and Gentofte Hospital
Organization:
Herlev and Gentofte Hospital
Study Overview
Official Title:
Pilot for a National Virtual Trial Testing Remote Sleep Apnea Evaluation in Patients With Atrial Fibrillation - Mini VIR-SAAF
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Mini VIR-SAAF
Brief Summary:
This is an investigator-initiated virtual or decentralized trial that includes a postal parcel mail-in containing sensors for SA diagnosis NightOwl and physical activity SENS Motion in addition to smart-phone based heart rhythm FibriCheck monitoring in participants with paroxysmal or persistent AF A case-coordinator the investigators will manage all participant contacts virtually during the study from inclusion to follow-up
Detailed Description:
Objectives The main aim of the pilot trial is in a completely decentralizedvirtual setting to evaluate whether SA home-evaluation physical tracking by a home-monitoring device and heart rhythm monitoring by a smart-phone application in patients with AF are feasible
Inclusion
Confirmation of study eligibility will be performed entering key variables including telephone number into a secure web based program RedCap at the Cardiovascular Research Center at Herlev-Gentofte Hospital
After inclusion participants will receive a mail-in package containing the NightOwl device and the SENS Motion device Online questionnaires for survey 1 will be pushed to participants via RedCap which includes basic participant information including mail address height weight BMI self-measured neck circumference and employment status and the questionnaires Atrial Fibrillation Effect on QualiTy-of-life AFEQT AF severity scale AFSS Pittsburgh Sleep Quality Index PSQI and The eHealth Literacy Questionnaire eHLQ
Furthermore a clinical evaluation form will be filled out online in RedCap by the case coordinator based on electronic charts or from the video meeting which includes
CPR number sex birthdate questions related to AF modified European Heart Rhythm Association mEHRA symptom classification 0-4 concomitant CVD medication antithrombotic medication rate-lowering drugs anti-arrhythmic drugs date of first AF detected type of AF paroxysmal or persistent AF and other relevant medical conditions
Postal Parcel 1
After completing survey 1 a postal parcel postal parcel 1 including the NightOwl device and the SENS Motion will be sent to the participants address The postal parcel 1 will also include detailed written information and instructions for the devices and applications together with a user-friendly written overview of the study design As soon as the participants receive the postal parcel 1 the participant will begin their home monitoring with the 4 nights of NightOwl monitoring the 7 days of activity tracker round 1 with SENS Motion and the heart rhythm monitoring with the FibriCheck application
Return of equipment 1
After completing the 4 nights of NightOwl monitoring and the 7 days of activity tracker round 1 with SENS Motion the participants will ship the used SENS Motion and NightOwl device back to the case-coordinator This will be done via a prepaid shipping label
SA evaluation in cooperation with the Danish Center for Sleep Medicine Glostrup
Participants diagnosed with having a NightOwl evaluation showing moderate to severe SA ie AHI15 will be scheduled for a multidisciplinary meeting including case coordinator SA specialist and cardiologist at site At this meeting the participant will be informed that the evaluation shows that significant SA is likely Based on all information including patient symptoms patient preferences and assessment by the multidisciplinary team the following strategies is planned 1 fast-track initiation of remote CPAP treatment initiation 2 additional conventional SA work-up or CPAP treatment initiation at Glostrup Hospital Copenhagen 3 advice eg sleep position trainer or 4 no further investigationtreatment
The strategy is based on clinical judgment In case the assessment results in 1 or 2 the patient will be informed that a final diagnosis will be made by Dansk Center for Søvnsygdomme including the department will be responsible for any potential subsequent treatment
Conventional SA work-up or CPAP treatment initiation In a subset of participants clinically selected for either a need for further clinically conventional SA workup or CPAP treatment a referral to Danish Center for Sleep Medicine Glostrup will be made
The decision to either initiate treatment remotely or conventional is based on clinical judgment
Postal Parcel 2
At week 10 a postal parcel postal parcel 2 with the SENS Motion will be sent to the participants address for activity tracking round 2 As soon as the participants receive the postal parcel 2 the participant will begin their 7 days of activity tracker round 2 with SENS Motion
Return of equipment 2
After completing the 7 days of activity tracker round 2 with SENS Motion the participants will ship their used device back to the case-coordinator This will be done via a prepaid shipping label
Follow up
After completing the 7 days of activity tracker round 2 questionnaires will once again be pushed digitally to participants including AFEQT AFSS and PSQI The questionnaires will be pushed again to participants a month after survey 2
At week 12 the participant will be scheduled for a video meeting where the participants own study results will be presented
Evaluation Qualitative interviews
Finally a subset of participants will be invited to focus-group interviews One whole day workshop will be planned for evaluating major project elements remote informed consent eHealth literacy digital device instructions communication multidisciplinary meeting and CPAP treatment compliance The evaluations will be used for identifying barriers for virtual trial inclusion the use of devices and online completion of questionnaires
Inclusion
Confirmation of study eligibility will be performed entering key variables including telephone number into a secure web based program RedCap at the Cardiovascular Research Center at Herlev-Gentofte Hospital
After inclusion participants will receive a mail-in package containing the NightOwl device and the SENS Motion device Online questionnaires for survey 1 will be pushed to participants via RedCap which includes basic participant information including mail address height weight BMI self-measured neck circumference and employment status and the questionnaires Atrial Fibrillation Effect on QualiTy-of-life AFEQT AF severity scale AFSS Pittsburgh Sleep Quality Index PSQI and The eHealth Literacy Questionnaire eHLQ
Furthermore a clinical evaluation form will be filled out online in RedCap by the case coordinator based on electronic charts or from the video meeting which includes
CPR number sex birthdate questions related to AF modified European Heart Rhythm Association mEHRA symptom classification 0-4 concomitant CVD medication antithrombotic medication rate-lowering drugs anti-arrhythmic drugs date of first AF detected type of AF paroxysmal or persistent AF and other relevant medical conditions
Postal Parcel 1
After completing survey 1 a postal parcel postal parcel 1 including the NightOwl device and the SENS Motion will be sent to the participants address The postal parcel 1 will also include detailed written information and instructions for the devices and applications together with a user-friendly written overview of the study design As soon as the participants receive the postal parcel 1 the participant will begin their home monitoring with the 4 nights of NightOwl monitoring the 7 days of activity tracker round 1 with SENS Motion and the heart rhythm monitoring with the FibriCheck application
Return of equipment 1
After completing the 4 nights of NightOwl monitoring and the 7 days of activity tracker round 1 with SENS Motion the participants will ship the used SENS Motion and NightOwl device back to the case-coordinator This will be done via a prepaid shipping label
SA evaluation in cooperation with the Danish Center for Sleep Medicine Glostrup
Participants diagnosed with having a NightOwl evaluation showing moderate to severe SA ie AHI15 will be scheduled for a multidisciplinary meeting including case coordinator SA specialist and cardiologist at site At this meeting the participant will be informed that the evaluation shows that significant SA is likely Based on all information including patient symptoms patient preferences and assessment by the multidisciplinary team the following strategies is planned 1 fast-track initiation of remote CPAP treatment initiation 2 additional conventional SA work-up or CPAP treatment initiation at Glostrup Hospital Copenhagen 3 advice eg sleep position trainer or 4 no further investigationtreatment
The strategy is based on clinical judgment In case the assessment results in 1 or 2 the patient will be informed that a final diagnosis will be made by Dansk Center for Søvnsygdomme including the department will be responsible for any potential subsequent treatment
Conventional SA work-up or CPAP treatment initiation In a subset of participants clinically selected for either a need for further clinically conventional SA workup or CPAP treatment a referral to Danish Center for Sleep Medicine Glostrup will be made
The decision to either initiate treatment remotely or conventional is based on clinical judgment
Postal Parcel 2
At week 10 a postal parcel postal parcel 2 with the SENS Motion will be sent to the participants address for activity tracking round 2 As soon as the participants receive the postal parcel 2 the participant will begin their 7 days of activity tracker round 2 with SENS Motion
Return of equipment 2
After completing the 7 days of activity tracker round 2 with SENS Motion the participants will ship their used device back to the case-coordinator This will be done via a prepaid shipping label
Follow up
After completing the 7 days of activity tracker round 2 questionnaires will once again be pushed digitally to participants including AFEQT AFSS and PSQI The questionnaires will be pushed again to participants a month after survey 2
At week 12 the participant will be scheduled for a video meeting where the participants own study results will be presented
Evaluation Qualitative interviews
Finally a subset of participants will be invited to focus-group interviews One whole day workshop will be planned for evaluating major project elements remote informed consent eHealth literacy digital device instructions communication multidisciplinary meeting and CPAP treatment compliance The evaluations will be used for identifying barriers for virtual trial inclusion the use of devices and online completion of questionnaires
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None