Sickle Cell DiseaseNCT03629678
Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
A study testing mobile health application in people with Sickle Cell Disease, run by Vanderbilt University Medical Center at 2 sites in United States.
Trial summary
SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Sickle Cell Disease
- What is being tested?
- mobile health application
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 2 sitesUnited States
- Study dates
- 1 Jul 2018to 1 Jul 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- receives care at the community health clinic,
- diagnosis of SCD (Hgb SS, SC, Sβ-thal),
- ability to speak and understand written English
- has access to a smartphone or computer
- between 18-70 years.
Who cannot join
- lack of access to a smartphone or computer
- inability to speak and understand written English
Trial locations and contacts
2 sites in 1 country.
United States2 sites
The Ohio State University Medical Center
Columbus, Ohio, 43212
Vanderbilt University
Nashville, Tennessee, 37203
About this study
SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Prior research indicates that increased disease-specific knowledge correlates with improved clinical outcomes in SCD. Thus, targeting strategies to improve disease-specific knowledge is a high priority in the care of individuals with SCD. Significant evidence describes how educational materials, including online educational programs, can be used to increase disease-specific knowledge. In this study, the investigators will evaluate a mobile phone technology intervention based on the prior evidence that technologies can improve SCD-specific knowledge.
Read the detailed description
Sickle cell disease (SCD) is an inherited blood disorder that affects over 100,000 Americans, an underserved population with low life expectancy and risk for significant and life-threatening medical complications (e.g., stroke). Adults with SCD are overwhelmingly members of socially disadvantaged groups, increasing their risk for disparities in care. Annual health expenditure for individuals with SCD in the United States is about $1.5 billion, primarily from multiple emergency room visits (230,000 visits/year) for management of acute complications. Use of disease-specific knowledge has emerged as a powerful tool to decrease health care utilization. Significant evidence has described how to increase disease-specific knowledge using educational materials, including online educational programs in individuals managing chronic diseases, including SCD. Patient knowledge and use of disease-specific information like evidence-based clinical guidelines has the potential to decrease health care utilization. In 2014, the National Heart, Lung, and Blood Institute (NHLBI) published guidelines for evidence-based management of SCD for health care providers. However, to date, no national strategy has been developed to make these guidelines patient-centered, accessible, and actionable for adults with SCD. Federal Meaningful Use regulations have recommended using health-related technologies to improve patient access to their health information to promote patient engagement. Yet, many adults with SCD are not yet fully engaged in use of health technologies because they are unsure of the best format (e.g., mobile or web-based), leading to a health care technology gap. Mobile health applications (apps) that include patient-centered care guidelines could engage and activate this population given the high use of mobile technologies, potentially closing this health technology gap and improving health outcomes.
Evaluate the feasibility and acceptability of the refined iManage in a pilot study with adults with SCD. The investigators will recruit 50 adults from the population of 250 adults with SCD at the Vanderbilt Meharry Sickle Cell Disease Center of Excellence and the ohio state university comprehensive sickle cell center for a 6-month pilot study to evaluate usability, acceptance, and usage. At the end of the study, the investigators will conduct interviews with a subset of participants to gain an in-depth understanding of usage patterns and how to sustain engagement to promote ongoing app use.
Evaluate the efficacy of the refined iManage app on SCD-specific knowledge. The investigators will test the hypothesis that the refined iManage will increase SCD-specific knowledge by measuring SCD-specific knowledge at the start and end of the 6-month pilot study. the investigators will conduct exploratory analyses of secondary outcomes including patient activation, adherence to guidelines, missed days of school/work, and self-efficacy.
- Conditions
- Sickle Cell Disease
- Being tested
- mobile health application
- Keywords
- mhealth
- Medical subject headings
- Anemia, Sickle Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mobile health applicationOther
The user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals.
| Study group | Role | What they receive |
|---|---|---|
| Control group (Booklets) | No intervention | Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit |
| mobile health application | Active comparator | Group 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. Receives: Other: mobile health application |
What is being measured
The primary outcome is the main question the study is designed to answer.
SCD-specific Knowledge
Knowledge about SCD. This is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers which will be reported. There were a total of 39 questions, so a maximum score of 39.
This is not a scale.
Measured: 6 months
Secondary outcomes (4)
Self-efficacy
sickle cell self-efficacy scale, as described in Edwards R, Telfair J, Cecil H, Lenoci J. Reliability and validity of a self-efficacy instrument specific to sickle cell disease. Behav Res Ther. 2000;38(9):951-63.
Scale is 0-45, higher score is better Scale has no subscales and measures self-efficacy
Measured: 6 months
Healthcare Utilization (ER Visits and Hospitalizations)
The investigators will measure a count of the # ER visits and # of hospitalizations (i.e., # ER visits + # hospitalizations)
Measured: 6 months
Usage and Usability of the mHealth Application
How often app and functionality was used. Usability will be measured by the widely used and validated System Usability Scale as described in Brooke J. SUS-A quick and dirty usability scale. Usability evaluation in industry. 1996;189(194):4-7. The mobile health application for the guidelines has built-in tracking of the number of times the application is launched, how many times each of the functions are used, and how many times each button has been pushed. To measure usage, the investigators will record the numbers of each of these events for each participant. In addition to total use, the investigators will measure usage over time including any use, initial use, periodic use, and sustained use.
SUS scale is 0-100, higher score is better. Scale has no subscales and measures usability of the app
Measured: 6 months
Patient Activation Measure
The Patient Activation Measure (PAM) is a 10-item questionnaire to assesses a patient's knowledge, skills, and confidence in managing their health and healthcare. Response options range from (1) disagree strongly to (4) agree strongly, and an additional "not applicable" option. The sum of responses (excepting non-applicable items) are converted using Insignia Health's proprietary algorithm (that takes into account the specific wording and weighting of each item in the survey) into a final PAM score on a 0-100 scale. Higher PAM scores indicate a greater level of patient activation in managing their health.
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 posted14 Aug 2018
- Study start1 Jul 2018
- Primary completion1 Jul 2023
- Study completion1 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert M Cronin, MD, MS, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03629678
- Sponsor's protocol ID
- K23HL141447-2
- Other IDs
- K23HL141447
- Status last verified
- Jan 2025
- First submitted
- 7 Aug 2018
- Last updated
- 14 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Cronin RM, Quaye N, Liu X, Landes K, Crosby LE, Kassim AA, Volanakis EJ, Schnell PM, DeBaun MR. A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Blood Adv. 2023 Oct 24;7(20):6184-6190. doi: 10.1182/bloodadvances.2023010676.
PubMed 37595029
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Patient-Centered Guidelines in a Technology Platform to Improve Health Care in Adults With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT03629678
- Acronym / sponsor ID
- K23HL141447-2
- Conditions
- Sickle Cell Disease
- Keywords
- mhealth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Ohio State University, National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2023 (actual)
- First posted
- 14 Aug 2018 (actual)
- Results
- Posted 27 Jun 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
SCD is an inherited disorder of hemoglobin that affects over 100,000 Americans, most of whom live in low-resourced neighborhoods. Acute SCD complications result in 230,000 emergency department visits and $1.5 billion annually in acute-care expenditures. Prior research indicates that increased disease-specific knowledge correlates with improved clinical outcomes in SCD. Thus, targeting strategies to improve disease-specific knowledge is a high priority in the care of individuals with SCD. Significant evidence describes how educational materials, including online educational programs, can be used to increase disease-specific knowledge. In this study, the investigators will evaluate a mobile phone technology intervention based on the prior evidence that technologies can improve SCD-specific knowledge.
Detailed description
Sickle cell disease (SCD) is an inherited blood disorder that affects over 100,000 Americans, an underserved population with low life expectancy and risk for significant and life-threatening medical complications (e.g., stroke). Adults with SCD are overwhelmingly members of socially disadvantaged groups, increasing their risk for disparities in care. Annual health expenditure for individuals with SCD in the United States is about $1.5 billion, primarily from multiple emergency room visits (230,000 visits/year) for management of acute complications. Use of disease-specific knowledge has emerged as a powerful tool to decrease health care utilization. Significant evidence has described how to increase disease-specific knowledge using educational materials, including online educational programs in individuals managing chronic diseases, including SCD. Patient knowledge and use of disease-specific information like evidence-based clinical guidelines has the potential to decrease health care utilization. In 2014, the National Heart, Lung, and Blood Institute (NHLBI) published guidelines for evidence-based management of SCD for health care providers. However, to date, no national strategy has been developed to make these guidelines patient-centered, accessible, and actionable for adults with SCD. Federal Meaningful Use regulations have recommended using health-related technologies to improve patient access to their health information to promote patient engagement. Yet, many adults with SCD are not yet fully engaged in use of health technologies because they are unsure of the best format (e.g., mobile or web-based), leading to a health care technology gap. Mobile health applications (apps) that include patient-centered care guidelines could engage and activate this population given the high use of mobile technologies, potentially closing this health technology gap and improving health outcomes.
Evaluate the feasibility and acceptability of the refined iManage in a pilot study with adults with SCD. The investigators will recruit 50 adults from the population of 250 adults with SCD at the Vanderbilt Meharry Sickle Cell Disease Center of Excellence and the ohio state university comprehensive sickle cell center for a 6-month pilot study to evaluate usability, acceptance, and usage. At the end of the study, the investigators will conduct interviews with a subset of participants to gain an in-depth understanding of usage patterns and how to sustain engagement to promote ongoing app use.
Evaluate the efficacy of the refined iManage app on SCD-specific knowledge. The investigators will test the hypothesis that the refined iManage will increase SCD-specific knowledge by measuring SCD-specific knowledge at the start and end of the 6-month pilot study. the investigators will conduct exploratory analyses of secondary outcomes including patient activation, adherence to guidelines, missed days of school/work, and self-efficacy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Control group (Booklets) | No intervention | –Group 1 will receive the control arm with a paper booklet of the patient-centered SCD-guidelines with education by a health care provider at a single visit |
| mobile health application | Active comparator | Other: mobile health applicationGroup 2 will receive continuous access to technology-based patient-centered SCD-specific guidelines using a user-driven technological platform, plus a paper booklet of the guidelines with education by a health care provider at a single visit. The mobile app will include interactive content and a fully searchable collection of the SCD-specific guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- receives care at the community health clinic,
- diagnosis of SCD (Hgb SS, SC, Sβ-thal),
- ability to speak and understand written English
- has access to a smartphone or computer
- between 18-70 years.
Key exclusion criteria (2 listed)
- lack of access to a smartphone or computer
- inability to speak and understand written English
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 |
|---|---|---|
| mobile health applicationThe user-driven technological tool will include an mHealth mobile phone application. Features of the application will be based on preliminary work from the investigators' sites. The mobile app will include fully searchable provider-facing and patient-facing interfaces with the SCD-specific guidelines. The provider-facing interface, designed to be used by providers, will be separated by patient's age to accommodate pediatric and adult providers. The patient-facing interface will display the guidelines that are age- and health literacy-appropriate. Through the mobile app, the investigators will reinforce important points of guideline content; motivate patient engagement through quizzes and text-message reminders; and facilitate peer support, for instance by forming teams to compete against each other to attain goals. | Other | mobile health application |
Primary outcome
SCD-specific Knowledge
Time frame: 6 months
Knowledge about SCD. This is a questionnaire that is multiple choice and asks questions about sickle cell disease with one correct answer and 3 incorrect answers. The investigators will sum up the number of correct answers which will be reported. There were a total of 39 questions, so a maximum score of 39. This is not a scale.
4 secondary outcomes
Self-efficacy
Time frame: 6 months
Healthcare Utilization (ER Visits and Hospitalizations)
Time frame: 6 months
Usage and Usability of the mHealth Application
Time frame: 6 months
Patient Activation Measure
Time frame: 6 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37595029Cronin RM, Quaye N, Liu X, Landes K, Crosby LE, Kassim AA, Volanakis EJ, Schnell PM, DeBaun MR. A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Blood Adv. 2023 Oct 24;7(20):6184-6190. doi: 10.1182/bloodadvances.2023010676.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mobile health application in people with Sickle Cell Disease, run by Vanderbilt University Medical Center at 2 sites 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 5 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 14 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Yes. Results are posted in the registry (first posted 27 Jun 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
SCD-specific Knowledge (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03629678, which also lists 1 linked publication.
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 14 Jan 2025.