NCT04470193

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

Completed NA Results posted Last updated 4 October 2024

What this trial tests

NA trial testing MyChildCMC app in Children With Medical Complexity in 50 participants. Completed in 19 March 2020.

Timeline

10 June 2019

Primary endpoint
19 March 2020

19 March 2020

Quick facts

Lead sponsor	University of Utah
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	50
Start date	10 June 2019
Primary completion	19 March 2020
Estimated completion	19 March 2020
Sites	1 location across United States

Drugs / interventions tested

• MyChildCMC app

Conditions studied

• Children With Medical Complexity — all drugs for Children With Medical Complexity →

Sponsor

University of Utah

Who can join

Adults 1 to 20, any sex, with Children With Medical Complexity. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Patient Quality of Life (QOL) Primary · 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.

Baseline QOL score

Group	Value	95% CI
MyChildCMC Intervention Group	62.7	± 14.8
Usual Care Group	54.4	± 15.0

1-month QOL score

Group	Value	95% CI
MyChildCMC Intervention Group	59.8	± 16.9
Usual Care Group	51.9	± 12.2

3-month QOL score

Group	Value	95% CI
MyChildCMC Intervention Group	55.2	± 15.3
Usual Care Group	50.8	± 15.6

Patient Emergency Department (ED)/Hospitalization Secondary · Change in ED/hospital admission between 3-month prior and 3-month post start of study/intervention

Compare NUMBER of ED and hospital admissions 3-month pre, and 3-month post study initiation between the intervention and Usual care groups.

3-month pre-study

Group	Value	95% CI
MyChildCMC Intervention Group	1.13	± 1.26
Usual Care Group	0.85	± 1.05

3-month post-study

Group	Value	95% CI
MyChildCMC Intervention Group	1.08	± 1.25
Usual Care Group	0.88	± 1.11

Number of Hospital Days Secondary · 3-month pre and 3-month post study start

Number of days (duration) participants were hospitalized

3-Month Pre

Group	Value	95% CI
Intervention Group	9.25	± 18.30
Usual Care Group	1.08	± 1.88

3-Month Post

Group	Value	95% CI
Intervention Group	4.54	± 6.95
Usual Care Group	2.46	± 3.84

Parent/Caregiver Satisfaction With Care Secondary · 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 (th

Group	Value	95% CI
MyChildCMC Intervention Group	26.93	± 2.22
Usual Care Group	24.14	± 4.21

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.