Trial Outcomes & Findings for Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies (NCT NCT02410252)
NCT ID: NCT02410252
Last Updated: 2020-10-22
Results Overview
This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. "Time in the study" here is defined as the number of days the subject spends in the study which is expected to be two weeks.
COMPLETED
NA
25 participants
Two Weeks
2020-10-22
Participant Flow
Adolescent-Caregiver dyads were recruited from the MGH Pediatric Cancer Center or the MGH Hospital for Children (Surgical Division). Recruitment began in early 2015 and was completed by April of 2017.
Participant milestones
| Measure |
Temperature Monitoring Group
This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the temperature monitoring device for 2 weeks.
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
19
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Temperature Monitoring Group
This was a single arm usability and feasibility study. All participants were enrolled into the same group and used the temperature monitoring device for 2 weeks.
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
|
Overall Study
Physician Decision
|
2
|
Baseline Characteristics
Use Feasibility of the iThermonitor in Pediatrics Patients on Myelosuppresive Therapies
Baseline characteristics by cohort
| Measure |
Temperature Monitoring Group
n=19 Participants
This was a single arm usability and feasibility study. All participants were enrolled into the same group where they used the study device to monitor their temperature for two weeks.
|
|---|---|
|
Age, Continuous
|
8 years
STANDARD_DEVIATION 5 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
19 participants
n=5 Participants
|
|
Age of Caregivers
|
41 years
STANDARD_DEVIATION 8 • n=5 Participants
|
|
Employment Status of Caregivers
Employed, full time
|
5 Participants
n=5 Participants
|
|
Employment Status of Caregivers
Employed, part time
|
3 Participants
n=5 Participants
|
|
Employment Status of Caregivers
Homemaker
|
6 Participants
n=5 Participants
|
|
Employment Status of Caregivers
Unemployed
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Two WeeksPopulation: Caregivers of participants using the device
This will be assessed by ability of the device to successfully capture, transmit and display the patient's body temperature data on the study iPod TouchiPad mini. To limit recall bias, subjects will be required to log the ability to view the temperature data on the iPad mini once a day for the entire duration of the study. The device will be deemed a feasible continuous temperature monitoring tool if at least 80% of study subjects are able to successfully use the iThermonitor to monitor their body temperature. A subject must be able to view temperature data on the provided iPad mini at least 80% of the time in the study to be considered successful. "Time in the study" here is defined as the number of days the subject spends in the study which is expected to be two weeks.
Outcome measures
| Measure |
Temperature Monitoring Group
n=19 Participants
This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.
|
|---|---|
|
Percent of Participants That Successfully Used the iThermonitor
View data at least once per day
|
100 % of participants
|
|
Percent of Participants That Successfully Used the iThermonitor
Reported receiving out of range alerts
|
75 % of participants
|
|
Percent of Participants That Successfully Used the iThermonitor
Reported receiving 3 or more out of range alerts
|
63 % of participants
|
SECONDARY outcome
Timeframe: 0 & 2 weeksPopulation: Caregivers of participants using the device.
The Generalized Anxiety Disorder, 7 item questionnaire was given to caregivers to see if using the device increased feelings of anxiety. This will be assessed using the GAD-7 questionnaire administered at enrollment and closeout
Outcome measures
| Measure |
Temperature Monitoring Group
n=19 Participants
This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.
|
|---|---|
|
Care Giver Anxiety
GAD Score_0 Weeks · No anxiety
|
12 Participants
|
|
Care Giver Anxiety
GAD Score_0 Weeks · Mild anxiety
|
3 Participants
|
|
Care Giver Anxiety
GAD Score_0 Weeks · Moderate anxiety
|
1 Participants
|
|
Care Giver Anxiety
GAD Score_0 Weeks · Severe anxiety
|
3 Participants
|
|
Care Giver Anxiety
GAD Score_2 Weeks · No anxiety
|
16 Participants
|
|
Care Giver Anxiety
GAD Score_2 Weeks · Mild anxiety
|
2 Participants
|
|
Care Giver Anxiety
GAD Score_2 Weeks · Moderate anxiety
|
0 Participants
|
|
Care Giver Anxiety
GAD Score_2 Weeks · Severe anxiety
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeksPopulation: Caregivers of participants using the device.
This will be assessed by questionnaires specifically designed for this study. We will be assessing ease of use, acceptability, connection and use problems like the device falling off the skin, usefulness of out-of-range temperature alerts and adverse reactions. We will also assess to see if the device helps to build caregiver self-efficacy skills in caring for the patient.
Outcome measures
| Measure |
Temperature Monitoring Group
n=19 Participants
This was a single arm usability and feasibility study. All participants were enrolled into the same group and monitored their body temperature using the study device for 2 weeks.
|
|---|---|
|
Usability, Acceptability and Satisfaction
Felt comfortable using device · Definitey True
|
13 Participants
|
|
Usability, Acceptability and Satisfaction
Felt comfortable using device · Mostly True
|
3 Participants
|
|
Usability, Acceptability and Satisfaction
Felt comfortable using device · A little true
|
1 Participants
|
|
Usability, Acceptability and Satisfaction
Felt comfortable using device · Not true
|
1 Participants
|
|
Usability, Acceptability and Satisfaction
Able to easily monitor temperature by using device · Definitey True
|
12 Participants
|
|
Usability, Acceptability and Satisfaction
Able to easily monitor temperature by using device · Mostly True
|
3 Participants
|
|
Usability, Acceptability and Satisfaction
Able to easily monitor temperature by using device · A little true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Able to easily monitor temperature by using device · Not true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Feel confident monitoring temperature with device · Not true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Device helpful stating discussions with doctor · Definitey True
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Device helpful stating discussions with doctor · Mostly True
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Device helpful stating discussions with doctor · A little true
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Device helpful stating discussions with doctor · Not true
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Using device makes me feel more connected to team · Definitey True
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Using device makes me feel more connected to team · Mostly True
|
7 Participants
|
|
Usability, Acceptability and Satisfaction
Using device makes me feel more connected to team · A little true
|
4 Participants
|
|
Usability, Acceptability and Satisfaction
Using device makes me feel more connected to team · Not true
|
6 Participants
|
|
Usability, Acceptability and Satisfaction
Would recommend device · Definitey True
|
10 Participants
|
|
Usability, Acceptability and Satisfaction
Would recommend device · Mostly True
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Would recommend device · A little true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Found app very useful in monitoring temperature · Definitey True
|
10 Participants
|
|
Usability, Acceptability and Satisfaction
Found app very useful in monitoring temperature · Mostly True
|
4 Participants
|
|
Usability, Acceptability and Satisfaction
Found app very useful in monitoring temperature · A little true
|
4 Participants
|
|
Usability, Acceptability and Satisfaction
Found app very useful in monitoring temperature · Not true
|
1 Participants
|
|
Usability, Acceptability and Satisfaction
Found out-of-range temp alert function useful · Definitey True
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Found out-of-range temp alert function useful · Mostly True
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Found out-of-range temp alert function useful · A little true
|
5 Participants
|
|
Usability, Acceptability and Satisfaction
Found out-of-range temp alert function useful · Not true
|
4 Participants
|
|
Usability, Acceptability and Satisfaction
Feel confident monitoring temperature with device · Definitey True
|
10 Participants
|
|
Usability, Acceptability and Satisfaction
Feel confident monitoring temperature with device · Mostly True
|
4 Participants
|
|
Usability, Acceptability and Satisfaction
Feel confident monitoring temperature with device · A little true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Would recommend device · Not true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Satisfied with ease of use of device · Definitey True
|
8 Participants
|
|
Usability, Acceptability and Satisfaction
Satisfied with ease of use of device · Mostly True
|
9 Participants
|
|
Usability, Acceptability and Satisfaction
Satisfied with ease of use of device · A little true
|
0 Participants
|
|
Usability, Acceptability and Satisfaction
Satisfied with ease of use of device · Not true
|
2 Participants
|
|
Usability, Acceptability and Satisfaction
Easy to learn to use device · Definitey True
|
13 Participants
|
|
Usability, Acceptability and Satisfaction
Easy to learn to use device · Mostly True
|
6 Participants
|
|
Usability, Acceptability and Satisfaction
Easy to learn to use device · A little true
|
0 Participants
|
|
Usability, Acceptability and Satisfaction
Easy to learn to use device · Not true
|
0 Participants
|
Adverse Events
Temperature Monitoring Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place