Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT06188247 |
| Other study ID # |
2305474 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
December 1, 2023 |
| Est. completion date |
August 2024 |
Study information
| Verified date |
January 2024 |
| Source |
Herlev and Gentofte Hospital |
| Contact |
Morten Lamberts, MD, PhD |
| Phone |
+45 22434186 |
| Email |
morten.kjoebek.lamberts[@]regionh.dk |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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.
Description:
Objectives The main aim of the pilot trial is in a completely decentralized/virtual 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 participant's 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 (i.e.
AHI>15) 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 (e.g. sleep position trainer), or 4) no further
investigation/treatment.
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 participant's 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.
