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NCT Number: NCT04470193

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

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.

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Key information

Conditions

Children with Medical Complexity Chronic Disease Disease Attributes Multiple Chronic Conditions Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

1 year–20 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Utah

Salt Lake City, Utah, 84112, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Participant Inclusion Criteria:

Children with complex medical conditions* ages 1 through 20 years with their primary caregiver (primary person caring for the child) who:

  • have been seen at Primary Children's Hospital within 365 days,
  • own a smartphone or a tablet computer with Internet access, and
  • are English speaking *Physician diagnosis was used to determine CMC diagnosis

Exclusion criteria

  • Critically ill children in imminent death
  • Non-English speakers

Treatment and study plan

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Patient Emergency Department (ED)/Hospitalization

    Time frame: 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.

  2. Number of Hospital Days

    Time frame: 3-month pre and 3-month post study start

    Number of days (duration) participants were hospitalized

  3. Parent/Caregiver Satisfaction With Care

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Utah

Other

Collaborators

  • HRSA/Maternal and Child Health Bureau

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jul 14, 2020
Registry last updated
Oct 4, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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