Trial Summary
What is the purpose of this trial?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.
Do I have to stop taking my current medications for the trial?
The trial does not specify if you need to stop taking your current medications. However, you must be on a steady state of hydroxyurea for 2 months to participate.
What data supports the idea that MED-Go App for Sickle Cell Disease is an effective treatment?
The available research shows that using mobile health apps like the MED-Go App can help people with sickle cell disease manage their condition better. One study found that adolescents who used a similar app more often reported feeling better and having less pain. Another study showed that adults using a mobile app with guidelines had high participation and completion rates, suggesting they found it helpful. These findings suggest that the MED-Go App could be effective in improving self-management and reducing pain for people with sickle cell disease.
12345What safety data exists for the MED-Go App for Sickle Cell Disease?
The available research does not provide specific safety data for the MED-Go App. However, similar mobile health applications for sickle cell disease, such as those evaluated in the studies, have shown high recruitment, retention, and adherence rates, indicating feasibility and acceptability. These studies suggest that mobile apps can be effective tools for self-management and education in sickle cell disease, but specific safety data for the MED-Go App itself is not mentioned.
23678Is the MED-Go App a promising treatment for sickle cell disease?
Yes, the MED-Go App is a promising treatment for sickle cell disease. It helps young people manage their health better by using a mobile app, which can improve their mood, reduce pain, and boost their confidence in handling their condition. The app also supports self-management, which is important for improving the quality of life for those with sickle cell disease.
12579Eligibility Criteria
This trial is for adolescents and young adults aged 12-21 with any type of sickle cell disease who have been on hydroxyurea steadily for at least 2 months. Participants must own or have access to a smartphone. Those recently hospitalized within the past week cannot join.Inclusion Criteria
I am between 12 and 21 years old.
Own of have access to a smartphone during the study period
I have been taking hydroxyurea consistently for 2 months.
+1 more
Exclusion Criteria
Recent hospitalizations within the past 7 days
Participant Groups
The MED-Go app, a behavioral intervention designed to help young people with sickle cell disease take their medication regularly, is being tested for its ease of use and whether it's well-received by users in this pilot randomized controlled trial.
2Treatment groups
Experimental Treatment
Active Control
Group I: MED-Go app InterventionExperimental Treatment1 Intervention
Participants will use MED-Go app intervention for a total of 12 weeks
Group II: Control ArmActive Control1 Intervention
Standard of care
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Ann & Robert H Lurie Children's Hospital of ChicagoChicago, IL
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Who Is Running the Clinical Trial?
Ann & Robert H Lurie Children's Hospital of ChicagoLead Sponsor
National Heart, Lung, and Blood Institute (NHLBI)Collaborator
References
Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. [2022]Sickle cell disease (SCD) is associated with significant health challenges that often worsen during adolescence. Living with SCD requires a substantial amount of self-management and mobile health (mHealth) holds considerable promise for assessing and changing behaviors to improve health outcomes. We integrated a mobile app as an adjunct to a group intervention (SCThrive) and hypothesized that more engagement with the mHealth app would increase self-management and self-efficacy for adolescents and young adults (AYA) with SCD. Twenty-six AYA ages 13-21 years (54% female; 46% HbSS genotype; all African-American/Black) received six weekly group sessions (three in-person, three online). Participants were provided with the mobile app (iManage for SCD) to record progress on their self-management goals and log pain and mood symptoms. The Transition Readiness Assessment Questionnaire (TRAQ-5) assessed self-management skills and the Patient Activation Measure (PAM-13) assessed self-efficacy at baseline and post-treatment. Logging on to the app more frequently was associated higher mood ratings (r = .54, CI[.18, .77], p = .006) and lower pain ratings (r = -.48, CI[-.77, -.02], p = .04). Regression analyses demonstrated that after controlling for scores at baseline, the number of logins to the app predicted self-management skills (p = .05, η2 = .17) and possibly self-efficacy (p = .08, η2 = .13). Our study findings indicate that it can be challenging to maintain engagement in mHealth for AYA with SCD, but for those who do engage, there are significant benefits related to self-management, self-efficacy, and managing pain and mood.
Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. [2022]Adolescents and young adults (AYAs) with sickle cell disease (SCD) are a vulnerable population with high risk of morbidity that could be decreased with effective self-management. Previous research suggests that mobile applications (apps) may facilitate AYA engagement in health-promoting behaviors. The objectives of this study were: (i) describe Internet access and use in AYA with SCD; (ii) identify barriers for self-management in this population; (iii) collaborate with AYA to co-design a mobile app that would minimize barriers; and (iv) evaluate the feasibility and acceptability of the app.
A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. [2023]Despite the increased number of evidence-based guidelines for sickle cell disease (SCD), dissemination of evidence-based guidelines in lay language for individuals or families with SCD has not been evaluated. We conducted a feasibility randomized controlled trial to determine the acceptability of a mobile health (mHealth) app with patient-facing guidelines to improve the knowledge of individuals with SCD about SCD-specific knowledge and reduce hospitalizations. Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled at 2 sickle cell centers between 2018 and 2022. Participants were randomized to receive either an mHealth app + booklet with patient-facing guidelines or a booklet with the guidelines alone. Participants completed surveys at baseline and a final 6-month visit. Approximately 67 of 74 (91%) agreed to participate and were randomized, with 50 of 67 (75%) completing all the study components. All participants who completed the study in the treatment arm used the app. Our results demonstrated high recruitment, retention, and adherence rate for the first randomized trial for an mHealth app with patient-facing guidelines in adults with SCD. This clinical trial was registered at https://www.clinicaltrials.gov/ as #NCT03629678.
Mobile health intervention for youth with sickle cell disease: Impact on adherence, disease knowledge, and quality of life. [2019]Adherence to illness self-management among youth with sickle cell disease (SCD) positively impacts health outcomes and decreases overall healthcare costs. Despite this, children with SCD face several barriers to adherence, with adherence rates that remain moderate to low. The current feasibility study examined the Intensive Training Program (ITP), a mobile health (mHealth) intervention for youth with SCD designed to promote disease knowledge, adherence, and patient-provider communication.
Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study. [2022]Individuals with sickle cell disease (SCD) and their caregivers may benefit from technology-based resources to improve disease self-management.
Educational technology on COVID-19 for families of children and adolescents with sickle cell disease. [2021]to construct and validate educational technology on COVID-19 and essential care for families of children/adolescents with sickle cell disease.
Improving Medication Adherence with Two-way Short Message Service Reminders in Sickle Cell Disease and Asthma. A feasibility randomized controlled trial. [2022]Sickle cell disease (SCD) is a childhood and adult disease that primarily affects African Americans, characterized by life threatening sequelae mitigated by medications. One-way and two-way short message service (SMS) medication reminders have differing efficacy in chronic diseases. There is limited literature about SMS medication reminders in SCD.
Usability and Acceptability of the QuestLeukemia Mobile Application: A Pilot Study for An Educational and Psychological Intervention for Children with Chronic Illnesses. [2022]It is widely accepted that educational interventions benefit children with chronic diseases (disease awareness and autonomy) or those undergoing medical procedures (decreased anxiety and improved satisfaction). Hematopoietic cell transplantation (HCT) is an intensive procedure to treat life-threatening diseases but is associated with multiple adverse medical experiences. QuestLeukemia (QuestED, Durham, NC) is a mobile app designed to educate pediatric patients preparing for HCT through age-appropriate videos and quizzes. Here we describe the results of the initial pilot study assessing acceptability and feasibility of QuestLeukemia app. Eligible participants were selected from a convenience sample (inpatient HCT unit and outpatient clinic). Participants spent 30-60 min using the app then completed a survey assessing the app for usability, accessibility, and user satisfaction. Participants identified the app as a useful tool for gaining disease-related knowledge and reported greater autonomy over their disease process. On average, patients indicated that the app was easy to use (M = 4.93), enjoyable (M = 4.79), and comprehensive (M = 4.71). Parents followed similar trends of satisfaction with the app. Pediatric HCT providers likewise reported that the app was easy to use (M = 4.22), enjoyable (M = 4.85), and educationally comprehensive (M = 4.77). The QuestLeukemia mobile application prototype provides an easy, enjoyable, and educational tool for pediatric patients undergoing HCT. This application was well received by patients, parents, and providers. These findings will be used to design future iterations of the game in clinical care.
Exploring the Challenges and Opportunities of eHealth Tools for Patients with Sickle Cell Disease. [2018]Sickle cell disease (SCD) is the most prevalent inherited blood disorder in the world. The symptoms decrease the quality of life of patients and can cause premature death. Self-help solutions for chronic patients are rising and increase the quality of life of patients. We are interested to identify the usefulness of eHealth tools for patients with SCD. We did a literature review to identify the main problems faced by patients and the existing eHealth solutions. The results show a low number of studies in the field but a multi-disciplinary interest. Positive health benefits for patients are reported as well as the need for more research. Patients and caregivers lack of education about the disease, healthy behaviors are unknown and clinical best practices underused. E-health tools can offer an appropriate support for the self-management of SCD by improving the quality of life of patients, by enhancing patient health literacy and by allowing clinicians to make better decisions.