Trial Outcomes & Findings for Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial (NCT NCT04470193)
NCT ID: NCT04470193
Last Updated: 2024-10-04
Results Overview
Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome.
COMPLETED
NA
50 participants
Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
2024-10-04
Participant Flow
Recruitment period was between June 2019 to December 2019. Recruitment occurred at Primary Children's Hospital in Salt Lake City, Utah.
Of the 68 subjects whose medical records were reviewed, 6 did NOT meet eligibility criteria (5 non-English speaking parents and 1 was on palliative care) and were NOT invited to participate. Of the 62 POTENTIALLY eligible subjects who were invited to participate in the study, 12 DECLINED to participate and WERE NOT enrolled, and 50 subjects AGREED to participate and were enrolled. Of the 50 subjects who were enrolled, 24 were randomized to MyChildCMC and 26 to usual care.
Participant milestones
| Measure |
MyChildCMC Intervention Group
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Standard of Care Group
Parents/patients randomized into the Standard of Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
26
|
|
Overall Study
COMPLETED
|
19
|
26
|
|
Overall Study
NOT COMPLETED
|
5
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
Baseline characteristics by cohort
| Measure |
MyChildCMC Intervention Group
n=24 Participants
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Usual Care Group
n=26 Participants
Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
24 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
48 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
7.29 years
n=5 Participants
|
9.65 years
n=7 Participants
|
8.52 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
20 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
38 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
3 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=5 Participants
|
26 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/interventionPopulation: Analysis included 50 participants at baseline (including 24 participants in the intervention group and 26 in the usual care group ), 40 participants at 1 months (including 16 in the intervention group and 24 in the usual care group), and 37 participants at 3 months (including 15 participants in the intervention and 22 participants in the usual care group).
Compared Mean QOL Change from Baseline to Each Follow-up Assessment Between the Two study Groups, using the Ellzey et. al.'s QOL survey questionnaire for children with complex medical conditions, which assesses multiple domains including physical health, mental health, sleep, pain, activities and general QOL. The total QOL score was reported and standardized to 100 points, with scores ranging from 20 (the lowest QOL) to 100 (the highest QOL). Higher QOL scores represent a better outcome.
Outcome measures
| Measure |
MyChildCMC Intervention Group
n=24 Participants
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Usual Care Group
n=26 Participants
Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
|---|---|---|
|
Patient Quality of Life (QOL)
Baseline QOL score
|
62.7 score on a scale, range from 20 to 100
Standard Deviation 14.8
|
54.4 score on a scale, range from 20 to 100
Standard Deviation 15.0
|
|
Patient Quality of Life (QOL)
1-month QOL score
|
59.8 score on a scale, range from 20 to 100
Standard Deviation 16.9
|
51.9 score on a scale, range from 20 to 100
Standard Deviation 12.2
|
|
Patient Quality of Life (QOL)
3-month QOL score
|
55.2 score on a scale, range from 20 to 100
Standard Deviation 15.3
|
50.8 score on a scale, range from 20 to 100
Standard Deviation 15.6
|
SECONDARY outcome
Timeframe: Change in ED/hospital admission between 3-month prior and 3-month post start of study/interventionPopulation: Using intention-to-treat analysis, we compared numbers of ED/hospital admissions and hospital days (3-month pre- and 3-month post-enrollment; enrollment hospitalization excluded) between the groups using generalized linear models with logarithmic link and Poisson regression analysis, estimating rate ratios (RR) and 95% confidence intervals (CI). Covariates included age, sex, and race/ethnicity.
Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups.
Outcome measures
| Measure |
MyChildCMC Intervention Group
n=24 Participants
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Usual Care Group
n=26 Participants
Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
|---|---|---|
|
Patient Emergency Department (ED)/Hospitalization
3-month pre-study
|
1.13 number of ED and hospital admissions
Standard Deviation 1.26
|
0.85 number of ED and hospital admissions
Standard Deviation 1.05
|
|
Patient Emergency Department (ED)/Hospitalization
3-month post-study
|
1.08 number of ED and hospital admissions
Standard Deviation 1.25
|
0.88 number of ED and hospital admissions
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 3-month pre and 3-month post study startPopulation: Number of hospital days were compared between the Intervention group participants and Usual Care group participants.
Number of days (duration) participants were hospitalized
Outcome measures
| Measure |
MyChildCMC Intervention Group
n=24 Participants
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Usual Care Group
n=26 Participants
Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
|---|---|---|
|
Number of Hospital Days
3-Month Pre
|
9.25 Days
Standard Deviation 18.30
|
1.08 Days
Standard Deviation 1.88
|
|
Number of Hospital Days
3-Month Post
|
4.54 Days
Standard Deviation 6.95
|
2.46 Days
Standard Deviation 3.84
|
SECONDARY outcome
Timeframe: Collected once at study end (3 months)Caregiver satisfaction with overall care of their children, using an adapted version (by Ellzey et. al) of Client Satisfaction Questionnaire for children with complex medical conditions, which has 6 questions measuring caregiver's confidence with ability to take care of child's health, consistency in doing things needed to take care of the child, availability of medical professional support, availability of social support, availability of a monitory system to help with child's home care and stress about child's health. We reported the total caregiver satisfaction scores, which range from 5 (the lowest satisfaction) to 30 (the highest satisfaction). Higher caregiver satisfaction scores represent a better outcome.
Outcome measures
| Measure |
MyChildCMC Intervention Group
n=24 Participants
Parents/patients randomized into the MyChildCMC Intervention Group will use the MyChildCMC app to monitor their child's daily symptoms for the duration of the study period (3 months). The MyChildCMC app includes a daily form consisting of 12 questions assessing child's vitals, pain, seizures, mood, and feeding as well as caregiver worry for the day. Daily reminders are sent to the parent to fill out the vitals form in the app. Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
MyChildCMC app: Patients/parents will self-monitor their symptoms daily using the MyChildCMC app completing the daily vitals form. After patient/parents complete the daily form, the app provides in-app alerts and graphs showing symptom data over time.
|
Usual Care Group
n=26 Participants
Parents/patients randomized into the Usual Care Group do not use the MyChildCMC app to monitor their child's daily symptoms and are instructed to continue with regular care for their child and to continue monitoring their child's symptoms on their own without the use of the app for the duration of the study period (3 months). Parents/participants will also fill out a quality of life survey at baseline, 1 month, and 3 months as well as a caregiver satisfaction survey at 3 months.
|
|---|---|---|
|
Parent/Caregiver Satisfaction With Care
|
26.93 score on a scale, ranging from 5 to 30
Standard Deviation 2.22
|
24.14 score on a scale, ranging from 5 to 30
Standard Deviation 4.21
|
Adverse Events
MyChildCMC Intervention Group
Usual Care 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