Technology-enabled Patient Support System for Self-management of CF

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Other: Open-platform patient support system (PSS) app

• Registration Number: NCT03910881
• Lead Sponsor: University of Alabama at Birmingham

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 Timeline

• Study First Submitted: 2019-04-08
• Study First Submitted QC: 2019-04-08
• Study First Posted: 2019-04-10
• Study Start: 2020-02-18
• Primary Completion: 2021-01-31
• Study Completion: 2021-01-31
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-01
• Last Update Posted: 2021-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Diagnosis of Cystic Fibrosis -

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Exclusion Criteria

None

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
open-platform patient support system	Open-platform patient support system (PSS) app	Proof of concept testing of app

Primary Outcome Measures

Name	Time	Method
Health-related quality of life (CFQ-R scores)	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 Outcome Measures

Name	Time	Method
Shared decision-making (CollaboRate scores)	6 months	Difference in CollaboRate scores between pre/post intervention. CollaboRate includes 3 questions, each on a scale from 0-9, with higher scores indicating more shared decision-making.
Patient/caregiver satisfaction (PACIC scores)	6 months	Difference in Patients' Assessment of Care for Chronic Conditions (PACIC) scores between pre/post intervention. PACIC includes 20 questions, each rated on a 5-point scale, with higher scores indicating higher quality of care.
Patient/caregiver activation (PAM scores)	6 months	Difference in Patient Activation Measure (PAM) scores between pre/post intervention. PAM includes 13 questions, each with 4 response options, summed on a 0-100 scale, with higher scores indicating higher activation level.

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States