Cystic FibrosisNCT03910881
Technology-enabled Patient Support System for Self-management of CF
A study testing Open-platform patient support system (PSS) app in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- Open-platform patient support system (PSS) app
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2020to 31 Jan 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Diagnosis of Cystic Fibrosis -
Who cannot join
- None
- -
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Alabama at Birmingham
Birmingham, Alabama, 35233
About this study
Official title: 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.
Read the 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).
- Conditions
- Cystic Fibrosis
- Being tested
- Open-platform patient support system (PSS) app
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open-platform patient support system (PSS) appOther
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 group | Role | What they receive |
|---|---|---|
| open-platform patient support system | Experimental | Proof of concept testing of app Receives: Other: Open-platform patient support system (PSS) app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 6 months
Secondary outcomes (6)
Shared decision-making (CollaboRate scores)
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.
Measured: 3 months
Shared decision-making (CollaboRate scores)
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.
Measured: 6 months
Patient/caregiver satisfaction (PACIC scores)
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.
Measured: 3 months
Patient/caregiver satisfaction (PACIC scores)
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.
Measured: 6 months
Patient/caregiver activation (PAM scores)
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.
Measured: 3 months
Patient/caregiver activation (PAM scores)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2019
- Study start18 Feb 2020
- Primary completion31 Jan 2021
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriela R Oates, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03910881
- Sponsor's protocol ID
- 300001749
- Status last verified
- May 2021
- First submitted
- 8 Apr 2019
- Last updated
- 4 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technology-enabled Patient Support System for Self-management of Pediatric Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT03910881
- Acronym / sponsor ID
- 300001749
- Conditions
- Cystic Fibrosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Study start
- 18 Feb 2020 (actual)
- Primary completion
- 31 Jan 2021 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 10 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Using a one-group pre-post design, evaluate the effect of the adapted technology-assisted PSS on patient-reported outcomes (PROs).
| Arm | Type | Receives |
|---|---|---|
| open-platform patient support system | Experimental | Other: Open-platform patient support system (PSS) appProof of concept testing of app |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Diagnosis of Cystic Fibrosis -
Key exclusion criteria (2 listed)
- None
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Open-platform patient support system (PSS) appThe 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. | Other | open-platform patient support system |
Primary outcome
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.
6 secondary outcomes
Shared decision-making (CollaboRate scores)
Time frame: 3 months
Shared decision-making (CollaboRate scores)
Time frame: 6 months
Patient/caregiver satisfaction (PACIC scores)
Time frame: 3 months
Patient/caregiver satisfaction (PACIC scores)
Time frame: 6 months
Patient/caregiver activation (PAM scores)
Time frame: 3 months
Patient/caregiver activation (PAM scores)
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open-platform patient support system (PSS) app in people with Cystic Fibrosis, run by University of Alabama at Birmingham at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life (CFQ-R scores) (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2021.