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| Name | Class |
|---|---|
| HRSA/Maternal and Child Health Bureau | FED |
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The investigators have developed a tool to facilitate self-management for children with medical complexity (complex, multisystem chronic diseases) called MyChildCMC (My Child's Complex Medical Condition). MyChildCMC is an online, phone application (app) that engages parents daily in ongoing monitoring of common, crosscutting acute symptoms, including respiratory distress, inadequate feeding/fluid intake, fever, altered mental status, pain, and seizure status. The MyChildCMC app also guides parents to recognize early warning signs for health deteriorations to avoid acute events (i.e., ED visits and/or hospitalizations).
Parent comments during the development of the MyChildCMC application revealed that the tool had potential in helping them manage their child's chronic conditions. This study will be the first to explore if online home monitoring using online technology is feasible, scalable, and can lead to improved CMC outcomes. This pilot trial for the MyChildCMC app was designed to determine preliminary impact by comparing outcomes (child QOL, child emergency department and hospital admissions, and parent/caregiver satisfaction with care) between the intervention and control groups. If successful, our approach will be a model for improving CMC care and reducing costs for families and children with medical complexity. Future MyChildCMC trials will integrate care coordination and a more robust alert system to help facilitate care and follow-up for patients.
Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MyChildCMC Intervention Group | Experimental | 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. |
|
| Standard of Care Group | No Intervention | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MyChildCMC app | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Quality of Life (QOL) | 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. | Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Emergency Department (ED)/Hospitalization | Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups. | Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention |
| Number of Hospital Days |
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Participant Inclusion Criteria:
Children with complex medical conditions* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Flory Nkoy, MD, MS, MPH | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19948596 | Background | Kogan MD, Strickland BB, Newacheck PW. Building systems of care: findings from the National Survey of Children With Special Health Care Needs. Pediatrics. 2009 Dec;124 Suppl 4:S333-6. doi: 10.1542/peds.2009-1255B. No abstract available. | |
| 9714637 | Background | McPherson M, Arango P, Fox H, Lauver C, McManus M, Newacheck PW, Perrin JM, Shonkoff JP, Strickland B. A new definition of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):137-40. doi: 10.1542/peds.102.1.137. No abstract available. |
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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.
Recruitment period was between June 2019 to December 2019. Recruitment occurred at Primary Children's Hospital in Salt Lake City, Utah.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline population includes 50 participants (who AGREED to participate in the study and were enrolled ): 24 in the MyChildCMC group and 26 in the usual care group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Patient Quality of Life (QOL) | 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. | 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). | Posted | Mean | Standard Deviation | score on a scale, range from 20 to 100 | Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention |
|
The study lasted 3 months and adverse events were collected during the study 3-month period
This was a minimal risk study and there was no adverse event related to the intervention during the study period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Baseline hospital days were imbalance, due to small sample size and data skewing. Analysis accounted for skewness and baseline number of ED/hospital admissions were similar, minimizing allocation bias. We had 2 deaths and 1 hospice discharge in MyChildCMC group, suggesting sicker subjects in this group due to our small sample size, or despite sicker children in MyChildCMC group, hospital days dropped but increased in controls, suggesting the effect size may be larger.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Flory Nkoy, MD, MS, MPH | University of Utah | 801-662-3660 | flory.nkoy@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 12, 2016 | Jul 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D000071069 | Multiple Chronic Conditions |
| ID | Term |
|---|---|
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Number of days (duration) participants were hospitalized |
| 3-month pre and 3-month post study start |
| Parent/Caregiver Satisfaction With Care | 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. | Collected once at study end (3 months) |
| 9651423 | Background | Newacheck PW, Strickland B, Shonkoff JP, Perrin JM, McPherson M, McManus M, Lauver C, Fox H, Arango P. An epidemiologic profile of children with special health care needs. Pediatrics. 1998 Jul;102(1 Pt 1):117-23. doi: 10.1542/peds.102.1.117. |
| 15121916 | Background | Strickland B, McPherson M, Weissman G, van Dyck P, Huang ZJ, Newacheck P. Access to the medical home: results of the National Survey of Children with Special Health Care Needs. Pediatrics. 2004 May;113(5 Suppl):1485-92. |
| 23184117 | Background | Cohen E, Berry JG, Camacho X, Anderson G, Wodchis W, Guttmann A. Patterns and costs of health care use of children with medical complexity. Pediatrics. 2012 Dec;130(6):e1463-70. doi: 10.1542/peds.2012-0175. Epub 2012 Nov 26. |
| 15882452 | Background | Feudtner C, Villareale NL, Morray B, Sharp V, Hays RM, Neff JM. Technology-dependency among patients discharged from a children's hospital: a retrospective cohort study. BMC Pediatr. 2005 May 9;5(1):8. doi: 10.1186/1471-2431-5-8. |
| 16700928 | Background | Dolk H, Parkes J, Hill N. Trends in the prevalence of cerebral palsy in Northern Ireland, 1981-1997. Dev Med Child Neurol. 2006 Jun;48(6):406-12; discussion 405. doi: 10.1017/S0012162206000909. |
| 17079547 | Background | Farooqi A, Hagglof B, Sedin G, Gothefors L, Serenius F. Chronic conditions, functional limitations, and special health care needs in 10- to 12-year-old children born at 23 to 25 weeks' gestation in the 1990s: a Swedish national prospective follow-up study. Pediatrics. 2006 Nov;118(5):e1466-77. doi: 10.1542/peds.2006-1070. |
| Background | Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2. |
| Background | Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08. |
| BG001 | Usual Care Group | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
|
| OG000 |
| 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. |
| OG001 | Usual Care Group | 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. |
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| Secondary | Patient Emergency Department (ED)/Hospitalization | Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups. | 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. | Posted | Mean | Standard Deviation | number of ED and hospital admissions | Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention |
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| Secondary | Number of Hospital Days | Number of days (duration) participants were hospitalized | Number of hospital days were compared between the Intervention group participants and Usual Care group participants. | Posted | Mean | Standard Deviation | Days | 3-month pre and 3-month post study start |
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| Secondary | Parent/Caregiver Satisfaction With Care | 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. | Posted | Mean | Standard Deviation | score on a scale, ranging from 5 to 30 | Collected once at study end (3 months) |
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| 2 |
| 24 |
| 0 |
| 24 |
| 0 |
| 24 |
| EG001 | Usual 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. | 0 | 26 | 0 | 26 | 0 | 26 |
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