Children With Medical ComplexityNCT04470193

Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial

A study testing MyChildCMC app in people with Children With Medical Complexity, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year to 20 years
Conditions the study is for: Children With Medical Complexity
What is being tested?: MyChildCMC app
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 50 participants
Where: 1 siteUnited States
Study dates: 10 Jun 2019to 19 Mar 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 1 year to 20 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

None listed.

Who cannot join

Critically ill children in imminent death
Non-English speakers

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Utah
Salt Lake City, Utah, 84112

Other trials in United States

About this study

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.

Read the detailed description

Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver:

Child Quality of Life (QOL)
Child Emergency Department (ED) and hospital admissions
Number of hospital days
Parent/Caregiver satisfaction with care

Conditions: Children With Medical Complexity
Being tested: MyChildCMC app
Keywords: medical complexity, multiple chronic conditions, children
Medical subject headings: Multiple Chronic Conditions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

MyChildCMC appOther
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.

Study groups in NCT04470193
Study group	Role	What they receive
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. Receives: Other: MyChildCMC app
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.

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention

Secondary outcomes (3)

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.
Measured: Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention
Number of Hospital Days
Number of days (duration) participants were hospitalized
Measured: 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.
Measured: Collected once at study end (3 months)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

10 Jun 201919 Mar 2020

First posted14 Jul 2020
Study start10 Jun 2019
Primary completion19 Mar 2020
Study completion19 Mar 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (10)Papers the sponsor has linked to this study.
Other trials for Children With Medical ComplexityStudies of the same condition, open and under way.
More trials run by University of UtahThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 50 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04470193
Sponsor's protocol ID: 088596
Status last verified: Jul 2024
First submitted: 6 Jul 2020
Last updated: 4 Oct 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19948596
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.
PubMed 9714637
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.
PubMed 9651423
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.
PubMed 15121916
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.
PubMed 23184117
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.
PubMed 15882452
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.
PubMed 16700928
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.
PubMed 17079547
Association CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.
Vestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Sibling Caregiver CMC Pilot Study
Children With Medical Complexity (CMC), Siblings
Not yet recruiting
Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity
Family Caregivers, Children With Medical Complexity (CMC)
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Recruiting
Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support
Children With Medical Complexity (CMC), Symptom Management
Active, not recruiting
Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
Feeding Tube, Children With Medical Complexity

All Children With Medical Complexity trials

Study at a glance

From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Self-management Intervention for Children With Chronic Medical Complexity: Pilot Feasibility Trial
ClinicalTrials.gov ID: NCT04470193
Acronym / sponsor ID: 088596
Conditions: Children With Medical Complexity
Keywords: medical complexity, multiple chronic conditions, children
Study type: Interventional
Recruitment status: Completed
Enrolment: 50 participants (actual)
Lead sponsor: University of UtahUniversity, hospital or other
Collaborators: HRSA/Maternal and Child Health Bureau
Study start: 10 Jun 2019 (actual)
Primary completion: 19 Mar 2020 (actual)
Study completion: 19 Mar 2020 (actual)
First posted: 14 Jul 2020 (actual)
Results: Posted 4 Oct 2024

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Aim: Investigators will assess the impact of the MyChildCMC app by comparing the following outcomes for the child and caregiver:

Child Quality of Life (QOL)
Child Emergency Department (ED) and hospital admissions
Number of hospital days
Parent/Caregiver satisfaction with care

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
MyChildCMC Intervention Group	Experimental	Other: MyChildCMC appParents/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.

Who may qualify

Ages: 1 year to 20 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (0 listed)

Key exclusion criteria (2 listed)

Critically ill children in imminent death
Non-English speakers

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
MyChildCMC appPatients/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.	Other	MyChildCMC Intervention Group

Primary outcome

Patient Quality of Life (QOL)
Time frame: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention
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.

3 secondary outcomes

Patient Emergency Department (ED)/Hospitalization
Time frame: Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention
Number of Hospital Days
Time frame: 3-month pre and 3-month post study start
Parent/Caregiver Satisfaction With Care
Time frame: Collected once at study end (3 months)

Results and safety

Results posted to the registry on 4 Oct 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MyChildCMC Intervention Group	24	19
Standard of Care Group	26	26

Primary outcome: Patient Quality of Life (QOL)

Time frame: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention. Mean (Standard Deviation). Unit: score on a scale, range from 20 to 100

Measure	MyChildCMC Intervention Group n = 24	Usual Care Group n = 26
Baseline QOL score	62.7 (14.8)	54.4 (15.0)
1-month QOL score	59.8 (16.9)	51.9 (12.2)
3-month QOL score	55.2 (15.3)	50.8 (15.6)

MyChildCMC Intervention Group vs Usual Care Group: p >0.05, generalized estimating equation model

Population analysed: 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).

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: The study lasted 3 months and adverse events were collected during the study 3-month period. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MyChildCMC Intervention Group	0 of 24 (0%)	0 of 24 (0%)	2 of 24
Usual Care Group	0 of 26 (0%)	0 of 26 (0%)	0 of 26

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 19948596Kogan 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.
Background: PubMed 9714637McPherson 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.
Background: PubMed 9651423Newacheck 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.
Background: PubMed 15121916Strickland 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.
Background: PubMed 23184117Cohen 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.
Background: PubMed 15882452Feudtner 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.
Background: PubMed 16700928Dolk 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.
Background: PubMed 17079547Farooqi 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.
BackgroundAssociation CsH. Optimizing Health Care for Children with Medical Complexity Annual Report 2013:2.
BackgroundVestal C. Improving Medicaid for 'Medically Complex' Kids. The Pew Charitable Trusts 2015;January 08.
Individual participant dataSharing planned: No

Related trials for Children With Medical Complexity

Recruiting
Sibling Caregiver CMC Pilot Study
Children With Medical Complexity (CMC), Siblings
Not yet recruiting
Pilot Trial of a Meaning And Problem-Solving (MAPS) Intervention for Family Caregivers of Children With Medical Complexity
Family Caregivers, Children With Medical Complexity (CMC)
Not yet recruiting
Automatic Versus As-Needed Follow-up After Hospitalization for Children With Medical Complexity
Children With Medical Complexity, Respiratory Tract Infections (RTI)
Recruiting
Nurse-led Integrated Home Service to Support Parents in Symptom Management for Children Requiring Respiratory Support
Children With Medical Complexity (CMC), Symptom Management
Active, not recruiting
Let's E.A.T.! (Eating With Assistive Technology): An Intervention to Support Children With Feeding Tubes and Tracheostomies
Feeding Tube, Children With Medical Complexity

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Flory Nkoy, MD, MS, MPH principal investigator

University of Utah

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing MyChildCMC app in people with Children With Medical Complexity, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Quality of Life (QOL) (time frame: Quality of Life assessed at baseline, then compared to 1 month and 3 months from start of study/intervention). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04470193, which also lists 10 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.