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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03910881
Recruitment Status : Completed
First Posted : April 10, 2019
Last Update Posted : May 4, 2021
Sponsor:
Information provided by (Responsible Party):
Gabriela R Oates, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE April 8, 2019
First Posted Date  ICMJE April 10, 2019
Last Update Posted Date May 4, 2021
Actual Study Start Date  ICMJE February 18, 2020
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
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
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: April 9, 2019)
  • Shared decision-making (CollaboRate scores) [ Time Frame: 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.
  • Shared decision-making (CollaboRate scores) [ Time Frame: 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) [ Time Frame: 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 satisfaction (PACIC scores) [ Time Frame: 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) [ Time Frame: 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 8, 2019)
  • Shared decision-making (CollaboRate scores) [ Time Frame: 6 months ]
    Difference in CollaboRate scores between pre/post intervention
  • Patient/caregiver satisfaction (PACIC scores) [ Time Frame: 6 months ]
    Difference in Patients' Assessment of Care for Chronic Conditions (PACIC) scores between pre/post intervention
  • Patient/caregiver activation (PAM scores) [ Time Frame: 6 months ]
    Difference in Patient Activation Measure (PAM) scores between pre/post intervention
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Technology-enabled Patient Support System for Self-management of CF
Official Title  ICMJE Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
Using a one-group pre-post design, evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs).
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Cystic Fibrosis
Intervention  ICMJE Other: Open-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.
Study Arms  ICMJE Experimental: open-platform patient support system
Proof of concept testing of app
Intervention: Other: Open-platform patient support system (PSS) app
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 8, 2019)
40
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Diagnosis of Cystic Fibrosis -

Exclusion Criteria:

None

-

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03910881
Other Study ID Numbers  ICMJE 300001749
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Gabriela R Oates, University of Alabama at Birmingham
Original Responsible Party Gabriela R Oates, University of Alabama at Birmingham, PhD
Current Study Sponsor  ICMJE University of Alabama at Birmingham
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alabama at Birmingham
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP