CHAMP For the Feeder: Pilot for CHAMP App Tube Weaning
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Enrollment
- 245
- Locations
- 2
- Primary Endpoint
- Adherence Discontinuation
Study Overview
Brief Summary
Single site evidence-based implementation of a mHealth application for remote patient monitoring for pediatric patients ready to wean from tube feedings (TFs). The primary objective of this study is to evaluate the CHAMP® ("CHAMP App") software platforms' expansion into TF weaning through Children's Mercy (CM) Kansas City's interdisciplinary feeding team (IDC). The investigators will use the current standard of care rates of tube weaning success, time to weaning, and healthcare team communication to evaluate the change after the implementation of the evidence-based CHAMP App. For equipoise of access, the study team will provide access in this pre-post design for parent/legally authorized representative (LAR)- child family access and use the CHAMP App software platform as soon as possible.
Detailed Description
Training: After consent to the study- parents/LAR will undergo training on the CHAMP App use by the study staff. The CHAMP App will be downloaded on the parent/LAR mobile device or an iPad that has been locked to contain only the CHAMP App and patient portal with mobile device management of the device by CM.
In addition to approval to begin a weaning trial by the IDC team providing primary nutrition management-beginning the weaning process may include these requirements:
- Weight for length or body mass index (BMI) must be stable. For children who are premature, syndromic, small for gestational age, or intrauterine growth restriction patients, this is at the dietitian's and provider's discretion. For typically developing patients, weight for length BMI z-score must be > -2.
- . Weekly feeding therapy is not required for tube weaning but will be strongly encouraged.
- A feeding therapist has assessed oral motor skills and agrees that the patient has sufficient skills to take all their calories by mouth.
CHAMP App use: Families will be provided with a weighing scale for home use; access to the CHAMP App mobile application or an iPad with the app and myChildren's Mercy App (patient portal) installed, if they prefer, during the study period. Data quality and validity will be ensured through the training of the healthcare team on data entry and out-of-range limits for each data value collected via the CHAMP web portal data entry forms. All data will be stored on the secure CM CHAMP Azure software platform with secure encryption database features.
Healthcare team CHAMP web portal use: The study team will review data entered by parents twice a week and as needed with questions and red flag concerns reported by parents/LAR. They will communicate back to parents with messages in the patient portal for documentation of messages that can be seen by other gastroenterology (GI) staff (GI clinic messages).
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 1 Month to 6 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Eligibility Criteria: Parent/LAR-Child dyad was referred for feeding difficulty and tube feeding care at Children's Mercy.
- •Inclusion Criteria
- •The child is between the ages of 1 month and five years 11 months.
- •Child is approved for a trial of tube weaning by the managing providers of their feeding difficulty.
Exclusion Criteria
- •Children who do not meet the criteria to begin tube weaning.
- •Children who are older than 6 years of age at time of enrollment.
- •Parent/LAR of parent/LAR-child dyad who do not speak one of the languages offered via the CHAMP application (English, Spanish, German, Chinese, Vietnamese, Arabic, Korean, French, Filipino, Burmese or Somali).
Outcomes
Primary Outcomes
Adherence Discontinuation
Time Frame: From enrollment to study endpoint, an average of 6 weeks
The study team will track parent use of the CHAMP App through tracking data discontinuation at the time of last data sent to the healthcare team prior to completion of study activities.
Adherence Initiation
Time Frame: Time in days, one event- the first day of data transfer of CHAMP App data after enrollment
The study team will track parent use of the CHAMP App through tracking data on 1) app initiation the time of First data sent to the healthcare team.
Success rate to tube weaning
Time Frame: From enrollment to study endpoint, an average of 6 weeks
Determine how the use of a remote patient monitoring mHealth software platform impacts the success rate (%) compared with those using only a standard outpatient interdisciplinary feeding tube using a tube weaning algorithm.
Time to weaning
Time Frame: From enrollment to study endpoint, an average of 4 weeks
Determine how the use of a remote patient monitoring mHealth software platform the time (weeks) for children that were able to get 100% of calories by mouth while maintaining age-appropriate growth, compared with those using only a standard outpatient interdisciplinary feeding tube using a tube weaning algorithm.
Adherence Implementation
Time Frame: From enrollment to study endpoint, an average of 6 weeks
The study team will track parent use of the CHAMP App through tracking data on implementation, the amount and type (feeding volumes, type, concentration, food amount, types (formula), and weights in kg) of asynchronous remote patient monitoring data received at the recommended intervals each week
Secondary Outcomes
No secondary outcomes reported
Investigators
Lori Erickson
Director, Remote Health Solutions
Children's Mercy Hospital Kansas City