Sickle Cell DiseaseNCT04688411
An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
A study testing MED-Go App in people with Sickle Cell Disease and Sickle Beta Zero Thalassemia, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.
Trial summary
The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). Read more about this study
- Who is it for?
- Ages 12 to 21 years
- Conditions the study is for
- Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia
- What is being tested?
- MED-Go App
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Sep 2020to 16 Sep 2025
- 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 12 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 12-21 years old
- Any sickle cell disease genotype
- On steady state of hydroxyurea for 2 months
- Own of have access to a smartphone during the study period
Who cannot join
- Recent hospitalizations within the past 7 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Ann & Robert H Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
About this study
The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.
Read the detailed description
Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea (HU), at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. AYA have adopted text messaging and smartphone apps at a fast pace, including those who have SCD.Existing evidence indicates that mobile health (mHealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in AYA, including SCD. The specific aim for this study is to test the feasibility and acceptability of the MED-Go app as an mHealth behavioral intervention to improve HU adherence among AYA with SCD.
- Conditions
- Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia, Sickle Cell Hemoglobin C
- Being tested
- MED-Go App
- Keywords
- sickle cell disease, hydrxoyurea, mHealth intervention
- Medical subject headings
- Anemia, Sickle Cell, Hemoglobin SC Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MED-Go AppBehavioural
A novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease
| Study group | Role | What they receive |
|---|---|---|
| MED-Go app Intervention | Other | Participants will use MED-Go app intervention for a total of 12 weeks Receives: Behavioral: MED-Go App |
| Control Arm | No intervention | Standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients achieving feasibility criteria of using the MED-Go app
Feasibility is defined as 70% of participants logging their daily HU 70% of the time over 12 weeks or 59 out of 84 study days. This will be reported as a dichotomous outcome, either yes or no.
Measured: 12 weeks
Secondary outcomes (2)
Scores of System Usability Scale (SUS)
App usability questionnaires, numerical values, range 10-50 (higher scores indicating better usability of the app)
Measured: 12 weeks
Hydroxyurea adherence rates
Adherence rate is defined as number of given HU doses as recorded by the app divided by total number of doses during study period.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2020
- Study start28 Sep 2020
- Primary completion16 Sep 2025
- Study completion16 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sickle Cell DiseaseStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Responsible party
- Principal investigator, Sherif Badawy, MD, Ann & Robert H Lurie Children's Hospital of Chicago
- Investigators
- Sherif M. Badawy, MD, MS, Principal investigator, Ann & Robert H Lurie Children's Hospital of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04688411
- Sponsor's protocol ID
- IRB 2020-3367
- Other IDs
- 1K23HL150232
- Status last verified
- Jul 2026
- First submitted
- 24 Dec 2020
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: All patient data will be deidentified
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Strategy to Improve Medication Adherence in Adolescents With Sickle Cell Disease
- ClinicalTrials.gov ID
- NCT04688411
- Acronym / sponsor ID
- IRB 2020-3367
- Conditions
- Sickle Cell Disease, Sickle Beta Zero Thalassemia, Sickle B+ Thalassemia, Sickle Cell Hemoglobin C
- Keywords
- sickle cell disease, hydrxoyurea, mHealth intervention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 28 Sep 2020 (actual)
- Primary completion
- 16 Sep 2025 (actual)
- Study completion
- 16 Sep 2025 (actual)
- First posted
- 30 Dec 2020 (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.
The primary objective of this study is to evaluate a potential behavioral intervention (MED-Go app). To meet this objective, the researchers will conduct a pilot randomized controlled trial to test the feasibility and acceptability of MED-Go app in adolescents and young adults (AYA) with sickle cell disease (SCD). The long-term goal of this research is to promote medication adherence behavior and improve health outcomes in AYA with SCD.
Detailed description
Sickle cell disease is the most common genetic disorder in the US, affecting about 100,000 Americans, and about 1 in 400 African American live births, incurring annual health care costs of $335 million. SCD can lead to serious complications including unpredictable, debilitating pain episodes, cardiopulmonary disease, stroke, and long-term end organ damage.These complications lead to significant declines in health-related quality of life (HRQOL) and other patient-reported outcomes (PROs), culminating in early mortality, particularly among AYA. Hydroxyurea (HU), at present, is the main FDA approved medication for SCD that reduces morbidity and mortality, improves HRQoL and lowers healthcare utilization.However, adherence to HU remains suboptimal with only 35-50% of patients achieving high adherence (≥90%), particularly among AYA with SCD. Low HU adherence has been associated with worse health outcomes, poor HRQOL and increased healthcare utilization. Low HU adherence is multifactorial, especially in AYA with other competing priorities and vulnerability in developmental and psychological factors contributing to adherence behavior. AYA have adopted text messaging and smartphone apps at a fast pace, including those who have SCD.Existing evidence indicates that mobile health (mHealth) behavioral interventions are feasible and acceptable with modest efficacy at improving medication adherence and self-management in AYA, including SCD. The specific aim for this study is to test the feasibility and acceptability of the MED-Go app as an mHealth behavioral intervention to improve HU adherence among AYA with SCD.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MED-Go app Intervention | Other | Behavioral: MED-Go AppParticipants will use MED-Go app intervention for a total of 12 weeks |
| Control Arm | No intervention | –Standard of care |
Who may qualify
- Ages
- 12 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Age 12-21 years old
- Any sickle cell disease genotype
- On steady state of hydroxyurea for 2 months
- Own of have access to a smartphone during the study period
Key exclusion criteria (1 listed)
- Recent hospitalizations within the past 7 days
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 |
|---|---|---|
| MED-Go AppA novel multifunctional mobile app (MED-Go) to improve adherence to hydroxyurea in patients with sickle cell disease | Behavioural | MED-Go app Intervention |
Primary outcome
Percentage of patients achieving feasibility criteria of using the MED-Go app
Time frame: 12 weeks
Feasibility is defined as 70% of participants logging their daily HU 70% of the time over 12 weeks or 59 out of 84 study days. This will be reported as a dichotomous outcome, either yes or no.
2 secondary outcomes
Scores of System Usability Scale (SUS)
Time frame: 12 weeks
Hydroxyurea adherence rates
Time frame: 12 weeks
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 31 Jul 2026.
- Individual participant dataSharing planned: No. All patient data will be deidentified
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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.
Sherif M. Badawy, MD, MS principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MED-Go App in people with Sickle Cell Disease and Sickle Beta Zero Thalassemia, run by Ann & Robert H Lurie Children's Hospital of Chicago 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 4 inclusion and 1 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 31 Jul 2026. 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?
Percentage of patients achieving feasibility criteria of using the MED-Go app (time frame: 12 weeks). 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 31 Jul 2026.