Cystic Fibrosis
Conditions
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).
Interventions
OTHEROpen-platform patient support system (PSS) app
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.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Using a one-group pre-post design, evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs).
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Diagnosis of Cystic Fibrosis -
Exclusion criteria
None \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life (CFQ-R scores) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Shared decision-making (CollaboRate scores) | 3 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) | 3 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) | 3 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. |
Countries
United States
Outcome results
None listed