Technology-enabled Patient Support System for Self-management of CF
May 1, 2021 updated by: Gabriela R Oates, University of Alabama at Birmingham
Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
This project will test a technology-enabled patient support system (PSS) as a self-management tool for children with CF and their family caregivers.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Alabama
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Birmingham, Alabama, United States, 35233
- University of Alabama at Birmingham
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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.
Eligibility Criteria
Ages Eligible for Study
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
Diagnosis of Cystic Fibrosis -
Exclusion Criteria:
None
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Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: open-platform patient support system
Proof of concept testing of app
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Health-related quality of life (CFQ-R scores)
Time Frame: 3 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.
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3 months
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Health-related quality of life (CFQ-R scores)
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Shared decision-making (CollaboRate scores)
Time Frame: 3 months
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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.
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3 months
|
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Shared decision-making (CollaboRate scores)
Time Frame: 6 months
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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.
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6 months
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Patient/caregiver satisfaction (PACIC scores)
Time Frame: 3 months
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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.
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3 months
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Patient/caregiver satisfaction (PACIC scores)
Time Frame: 6 months
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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.
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6 months
|
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Patient/caregiver activation (PAM scores)
Time Frame: 3 months
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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.
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3 months
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Patient/caregiver activation (PAM scores)
Time Frame: 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.
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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 Major Dates
Study Start (Actual)
February 18, 2020
Primary Completion (Actual)
January 31, 2021
Study Completion (Actual)
January 31, 2021
Study Registration Dates
First Submitted
April 8, 2019
First Submitted That Met QC Criteria
April 8, 2019
First Posted (Actual)
April 10, 2019
Study Record Updates
Last Update Posted (Actual)
May 4, 2021
Last Update Submitted That Met QC Criteria
May 1, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 300001749
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.