RECRUITING

SMART@Home Feasibility Trial

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools. Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study. A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.

Official Title

Self-Management Assistance for Recommended Treatment (SMART)@Home Care

Quick Facts

Study Start:2024-09-09
Study Completion:2025-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06159127

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:11 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * Patients diagnosed with a chronic medical condition requiring regular treatment, i.e., asthma
  2. * Ages 11-17
  3. * English fluency for patient and caregiver
  1. * Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review
  2. * Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Contacts and Locations

Study Contact

Kevin Hommel, PhD
CONTACT
513-803-0407
kevin.hommel@cchmc.org
Jessica King, BA
CONTACT
513-803-0920
jessica.king1@cchmc.org

Principal Investigator

Kevin Hommel, PhD
PRINCIPAL_INVESTIGATOR
Children's Hospital Medical Center, Cincinnati
Rachelle Ramsey, PhD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati
Matt Wortman, PhD
STUDY_CHAIR
Children's Hospital Medical Center, Cincinnati

Study Locations (Sites)

Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
United States

Collaborators and Investigators

Sponsor: Children's Hospital Medical Center, Cincinnati

  • Kevin Hommel, PhD, PRINCIPAL_INVESTIGATOR, Children's Hospital Medical Center, Cincinnati
  • Rachelle Ramsey, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati
  • Matt Wortman, PhD, STUDY_CHAIR, Children's Hospital Medical Center, Cincinnati

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-09
Study Completion Date2025-01-01

Study Record Updates

Study Start Date2024-09-09
Study Completion Date2025-01-01

Terms related to this study

Keywords Provided by Researchers

  • Asthma

Additional Relevant MeSH Terms

  • Asthma
  • Asthma in Children