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

NCT03910881 | Completed

• 1 other identifier: 300001749
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Cystic Fibrosis

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life (CFQ-R scores)

  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.

  3 months

• Health-related quality of life (CFQ-R scores)

  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.

  6 months

Secondary Outcomes (6)

• Shared decision-making (CollaboRate scores)

  3 months

• Shared decision-making (CollaboRate scores)

  6 months

• Patient/caregiver satisfaction (PACIC scores)

  3 months

• Patient/caregiver satisfaction (PACIC scores)

  6 months

• Patient/caregiver activation (PAM scores)

  3 months

Study Arms (1)

open-platform patient support system

EXPERIMENTAL

Proof of concept testing of app

Other: Open-platform patient support system (PSS) app

Interventions

Open-platform patient support system (PSS) app OTHER

The PSS app enables tracking and visualization of patient-selected health outcomes and sharing of select outcomes with family and providers. The CF clinical team and the family jointly decide which aspects of daily life to track, how often, and the content and frequency of patient-generated reports. Examples of daily care that can be tracked include symptoms (respiratory, gastrointestinal, pain), energy level, appetite, sleep, exercise, mood, medications, therapies, school/work attendance. Prior to a clinic visit, the patient/family generates a report of the outcomes they have been tracking, to help prepare for the visit and identify successes and areas of struggle. This information facilitates meaningful conversations during the visit and promotes shared decision-making. Patients/families can view their progress at any time and share selected outcomes with family and friends as often as desired.

open-platform patient support system

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of Cystic Fibrosis -

You may not qualify if:

• None

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

Perceived Stress Scale; Amyloid

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Intervention Hierarchy (Ancestors)

Multiprotein Complexes; Macromolecular Substances; Proteins; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Principal Investigator

Model Details: Using a one-group pre-post design, evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs).

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 10, 2019
• Study Start: February 18, 2020
• Primary Completion: January 31, 2021
• Study Completion: January 31, 2021
• Last Updated: May 4, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)