Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Health-related quality of life (CFQ-R scores)
Study Overview
Brief Summary
This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.
Detailed Description
The goal of this study is to refine and test a technology-enabled patient support system (PSS) as a tool for self-management of pediatric CF. The PSS includes two components: 1) patient-facing: an app with customizable dashboards for tracking patient-generated outcome measures and providing personally relevant decision-making support; and 2) clinic-based: clinical patient management and technical support. Using a one-group pretest-posttest design, we will evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs). Study hypothesis: Among pediatric CF patients treated at the UAB CF Center, the use of technology-aided PSS over 6 months will improve health-related quality of life (primary outcome) as well as patient satisfaction, patient activation, and shared decision-making (secondary outcomes).
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 15 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Diagnosis of Cystic Fibrosis -
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Health-related quality of life (CFQ-R scores)
Time Frame: 6 months
The primary outcome is difference in CFQ-R scores between pre/post intervention. The CFQ-R consists of 9 QOL domains (physical, role/school, vitality, emotion, social, body image, eating, treatment burden, health perceptions) and 3 symptom scales (weight, respiratory, and digestion). Items for each CFQ-R domain are summed to generate a domain score ranging from 0 to 100, with higher scores indicating better QOL.
Secondary Outcomes
- Shared decision-making (CollaboRate scores)(6 months)
- Patient/caregiver satisfaction (PACIC scores)(6 months)
- Patient/caregiver activation (PAM scores)(6 months)
Investigators
Gabriela R Oates
Assistant Professor, Principal Investigator
University of Alabama at Birmingham