Trial Outcomes & Findings for Novel Electronic Monitoring Devices (NEMD) to Monitor Adherence in Children With Asthma (NCT NCT04289714)

Results Overview

Number of participant interviewed in focus groups and interviews

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

35 participants

Primary outcome timeframe

16 weeks

Results posted on

2020-10-27

Participant Flow

The initial recruitment total was 30, however, due to low number of participants completing the study, ethics approval was sought to extend the study. As a result 35 participants were recruited at the end of the study period.

Participant milestones

Participant milestones
Measure	R-DOT Remote Directly Observed Therapy Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled	Haillie Smartinhaler Haillie Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled	Rafi-tone/INCA Rafi-tone with Flo-tone /INCA Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled
Overall Study STARTED	14	11	10
Overall Study COMPLETED	8	6	4
Overall Study NOT COMPLETED	6	5	6

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The number analysed are differ from the number at baseline as these are the ones that completed the study

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	R-DOT n=14 Participants Remote Directly Observed Therapy Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled	Haillie n=11 Participants Smartinhaler Haillie Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled	Rafi-tone/INCA n=10 Participants Rafi-tone with Flo-tone /INCA Novel Electronic Monitoring Device: Four Novel electronic Monitoring Devices were trialled	Total n=35 Participants Total of all reporting groups
Age, Continuous	14 years n=14 Participants	13.5 years n=11 Participants	12 years n=10 Participants	13 years n=35 Participants
Sex: Female, Male Female	4 Participants n=8 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	5 Participants n=6 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	2 Participants n=4 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	11 Participants n=18 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study
Sex: Female, Male Male	4 Participants n=8 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	1 Participants n=6 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	2 Participants n=4 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study	7 Participants n=18 Participants • The number analysed are differ from the number at baseline as these are the ones that completed the study
Race and Ethnicity Not Collected	—	—	—	0 Participants Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 16 weeks

Number of participant interviewed in focus groups and interviews

Outcome measures

Outcome measures
Measure	R-DOT n=8 Participants Remote Directly Observed Therapy	Haillie n=6 Participants Smartinhaler Haillie	Rafi-tone/INCA n=4 Participants Rafi-tone with Flo-tone /INCA
Acceptability Using Semi Structured Questionnaires in Focus Groups and Interviews	7 Participants	4 Participants	3 Participants

PRIMARY outcome

Timeframe: 16 weeks

Population: Number of discussion themes generated by participants regarding the usage of the devices

The Primary outcome measure is largely qualitative and based on collective themes. As a result there are no numerical measurements that differ each of the devices. In terms of accuracy of each device adherence data was collected but differs for each device depending on its functionality

Outcome measures

Outcome measures
Measure	R-DOT n=4 Number of themes generated Remote Directly Observed Therapy	Haillie n=4 Number of themes generated Smartinhaler Haillie	Rafi-tone/INCA n=4 Number of themes generated Rafi-tone with Flo-tone /INCA
Number of Themes Generated by Participants Regarding Usage of the Devices	4 ber of discussion themes generated by pa	4 ber of discussion themes generated by pa	4 ber of discussion themes generated by pa

SECONDARY outcome

Timeframe: 16 weeks

Percentage adherence to inhaled corticosteroids

Outcome measures

Outcome measures
Measure	R-DOT n=8 Participants Remote Directly Observed Therapy	Haillie n=6 Participants Smartinhaler Haillie	Rafi-tone/INCA n=4 Participants Rafi-tone with Flo-tone /INCA
Adherence to Inhaled Medication	72 Percentage adherence to inhaled corticos Standard Deviation 13	65 Percentage adherence to inhaled corticos Standard Deviation 19	87 Percentage adherence to inhaled corticos Standard Deviation 7

Adverse Events

R-DOT

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Haillie

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Rafi-tone/INCA

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sukeshi Makhecha

Royal Brompton Hospital

Phone: 0207-3528121

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place