mHealth App + Booklets for Sickle Cell Disease

(PF-Guide Trial)

Not yet recruiting at 4 trial locations

Overseen By Robert M Cronin, MD, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ohio State University

Disqualifiers: Non-English speakers, Under 18, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a mobile health app, combined with booklets, can help adults with sickle cell disease (SCD) reduce hospital visits, including ER and day hospitals. It compares this new approach to using only booklets and standard care to assess which is more effective and cost-efficient. Individuals who have received care at an SCD clinic for the past year and have a sickle cell diagnosis might be suitable candidates. The trial seeks to understand how the app and booklets can simplify and reduce the cost of managing SCD. As an unphased trial, this study offers a unique opportunity to contribute to innovative research that could enhance SCD management.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It is best to discuss this with the trial coordinators or your healthcare provider.

What prior data suggests that this mHealth app + booklets intervention is safe for adults with sickle cell disease?

Research has shown that using a mobile health (mHealth) app along with booklets to manage sickle cell disease (SCD) is safe. A study from multiple centers found positive results, supporting the use of this app and booklet combination. This indicates that participants generally tolerate the treatment well.

Another study examined how adults with SCD and their caregivers felt about using a mobile app for self-management. The feedback was positive, showing interest in the app, which suggests it does not cause major problems or side effects.

These findings indicate that the mHealth app with booklets is safe and well-received by people with SCD. No significant adverse events were reported in these studies, suggesting it is a low-risk option for managing SCD. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard care for sickle cell disease, which typically involves medications like hydroxyurea or blood transfusions, the mHealth app paired with booklets offers a unique approach by focusing on patient education and engagement. This treatment is distinctive because it combines a mobile health app with accessible guidelines and engaging content, alongside a booklet designed to be patient-friendly. Researchers are excited about this trial because it aims to empower patients with the knowledge and tools to better manage their condition, potentially improving adherence to care plans and enhancing overall quality of life.

What evidence suggests that the mHealth app + booklets could be effective for sickle cell disease?

Research shows that using a mobile health (mHealth) app along with booklets can help adults with sickle cell disease (SCD) manage their condition more effectively. In this trial, participants will receive the mHealth app and booklets, which studies have shown improve medication adherence in people with SCD by 19.8%. This suggests the app could help users stick to their treatment plans. Other studies have demonstrated that mHealth apps can lead to fewer hospital visits and better health outcomes. These findings strongly suggest that the combination of the mHealth app and booklets could reduce healthcare visits for people with SCD. ^{1 2 6 7 8}

Who Is on the Research Team?

Robert M Cronin, MD, MS

Principal Investigator

Ohio State University

Are You a Good Fit for This Trial?

This trial is for adults with Sickle Cell Disease. It's not clear what specific inclusion or exclusion criteria are, as they're not provided in the details given.

Inclusion Criteria

For adults with SCD: able to speak and understand written English

I have been diagnosed with sickle cell disease.

I am over 18 years old.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive patient-facing guidelines through a mHealth app and booklets to reduce acute healthcare utilization

12 months

Follow-up

Participants are monitored for healthcare utilization and patient-reported outcomes

6 months

What Are the Treatments Tested in This Trial?

Interventions

• mHealth app + booklets

Trial Overview The study tests if an mHealth app combined with booklets containing guidelines for Sickle Cell Disease can reduce hospital visits and be cost-effective compared to just booklets. Participants will be randomly assigned to either receive the app and booklets or only the booklets.

How Is the Trial Designed?

Group I: mHealth app + booklets Active Control 1 Intervention

A mHealth app that has patient facing guidelines and engaging content and a booklet with the guidelines that are made to be patient-facing.

Group II: Standard care Active Control 1 Intervention

Group 1 will receive the control arm with standard care

Who Is Running the Clinical Trial?

Ohio State University

Lead Sponsor

Trials

891

Recruited

2,659,000+

University of Illinois at Chicago

Collaborator

Trials

653

Recruited

1,574,000+

Vanderbilt University Medical Center

Collaborator

Trials

922

Recruited

939,000+

Washington University School of Medicine

Collaborator

Trials

2,027

Recruited

2,353,000+

Published Research Related to This Trial

A study involving 26 adolescents and young adults with sickle cell disease showed that using a mobile health app (iManage for SCD) can improve self-management skills and self-efficacy, especially for those who engage frequently with the app.

Increased app engagement was linked to better mood ratings and lower pain levels, suggesting that mobile health tools can be effective in helping young people manage their condition more effectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. Hood, AM., Nwankwo, C., Walton, A., et al.[2022]

The SmartVax system successfully engaged over 70% of vaccinated patients through SMS to report adverse events following immunization (AEFI), demonstrating its effectiveness in active monitoring.

Of the respondents, 11.3% reported possible AEFI, indicating that SMS-based surveillance can provide timely data to complement traditional passive reporting systems for vaccine safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. Leeb, A., Regan, AK., Peters, IJ., et al.[2022]

The SMART app demonstrated high feasibility for monitoring pain in sickle cell disease patients, with a median compliance rate of 75% over 28 days, indicating that patients found it useful for tracking their symptoms.

There was a strong correlation between pain severity reported by patients and their pain intensity measurements using the app, suggesting that SMART effectively captures the patients' experiences of pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Usability and Feasibility of an mHealth Intervention for Monitoring and Managing Pain Symptoms in Sickle Cell Disease: The Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). Jonassaint, CR., Shah, N., Jonassaint, J., et al.[2022]

A feasibility randomized controlled trial involving 67 adults with sickle cell disease (SCD) showed high recruitment (91%) and retention (75%) rates for a mobile health app designed to improve patient knowledge and potentially reduce hospitalizations.

All participants in the treatment group used the mHealth app, indicating strong adherence to the intervention, which suggests that mobile health tools can be effectively integrated into patient care for SCD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. Cronin, RM., Quaye, N., Liu, X., et al.[2023]

A survey of 480 patients and 31 general practitioners (GPs) revealed that while 56% of patients and 42% of GPs were willing to use mobile health (mHealth) applications for reporting adverse drug reactions (ADRs), willingness decreased with age for both groups.

Patients valued rapid feedback on consultation urgency, while GPs preferred information on medication administration difficulties; however, barriers included older patients' preference for personal contact with their GP and GPs' concerns about time and resource demands.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing a Mobile Health Application to Communicate Adverse Drug Reactions - Preconditions, Assessment of Possible Functionalities and Barriers for Patients and Their General Practitioners. Wakob, I., Schmid, GL., Nöhring, I., et al.[2022]

A study involving 46 adolescents and young adults (AYAs) with sickle cell disease (SCD) found that 69% had daily Internet access, indicating a strong potential for mobile health interventions.

The co-designed mobile app prototype, iManage, was rated as highly feasible and beneficial, suggesting it could effectively engage AYAs in self-management strategies to improve their health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. Crosby, LE., Ware, RE., Goldstein, A., et al.[2022]

A study involving 43 adults with sickle cell disease (SCD) and their caregivers revealed a strong interest in using a mobile health (mHealth) app to improve self-management of the disease, highlighting the potential for technology to enhance access to information and support.

Participants identified key features and preferences for the mHealth app, indicating that a user-friendly design could help overcome barriers to information access, especially for families living in rural areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study. Mayo-Gamble, TL., Quasie-Woode, D., Cunningham-Erves, J., et al.[2022]

eHealth tools have the potential to significantly improve the quality of life for patients with sickle cell disease (SCD) by enhancing self-management and health literacy, despite a limited number of studies in this area.

There is a notable gap in education for both patients and caregivers regarding SCD, indicating a need for more research and development of eHealth solutions to address these issues and improve clinical practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploring the Challenges and Opportunities of eHealth Tools for Patients with Sickle Cell Disease. Issom, DZ., Zosso, A., Ehrler, F., et al.[2018]

A mobile app was developed to facilitate reporting of adverse events following immunization (AEFI) for the influenza vaccine, and it successfully recorded 1104 data points from 38 participants, indicating its feasibility for AEFI reporting.

Despite the app's success in data collection, only 63% of participants downloaded it, and only 28% reported new or worsening health conditions after vaccination, suggesting barriers to wider adoption that need to be addressed in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An evaluation of the feasibility and usability of a proof of concept mobile app for adverse event reporting post influenza vaccination. Wilson, K., Atkinson, KM., Westeinde, J., et al.[2022]

The use of the MedWatcher app, combined with outreach to a Facebook patient community, significantly reduced the time to submit adverse event reports for the Essure device, averaging only 11.4 minutes compared to the typical 40 minutes for traditional methods.

Patients reported a high number of serious adverse events (77.6% of submissions), including hospitalization and permanent damage, and the reports submitted via the app were found to be 15 times more frequent than those through traditional reporting channels, indicating improved engagement and reporting quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing Patient Engagement in Pharmacovigilance Through Online Community Outreach and Mobile Reporting Applications: An Analysis of Adverse Event Reporting for the Essure Device in the US. Bahk, CY., Goshgarian, M., Donahue, K., et al.[2019]

In a study involving 153 employees, 42% participated in testing an app designed for reporting adverse events following immunization (AEFI), with 63% of users rating the experience positively, indicating good acceptance of the app-based technology.

Concerns about data protection were the main reason for declining participation, suggesting that improving data security measures could enhance the acceptability and effectiveness of app-based AEFI reporting systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. Nguyen, MTH., Ott, JJ., Caputo, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12161614/

Usage of a Multipurpose mHealth App Among Adults With ... Table 5. Associations between app usage and outcome for adults with sickle cell disease who were randomized to the app arm, completed baseline ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06919224?aggFilters=status%3Anot%2Cphase%3A

Delivering Patient-Facing Evidence-Based Guidelines ... The aims of this proposed study are Aim 1: evaluate the effectiveness of the patient-facing guidelines mHealth app + booklet intervention to decrease acute ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2473952923004585

A feasibility randomized controlled trial of an mHealth app ... Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled at 2 sickle cell centers between ...

4. researchgate.net researchgate.net/publication/373215048_A_feasibility_randomized_controlled_trial_of_a_mHealth_app_vs_booklets_for_patient-facing_guidelines

A feasibility randomized controlled trial of a mHealth app vs ... Primary outcome measures include recruitment, retention, and adherence rates. Adults with SCD were enrolled in two sickle cell centers between ...

5. ashpublications.org ashpublications.org/bloodadvances/article/7/23/7190/498036/A-multilevel-mHealth-intervention-boosts-adherence

A multilevel mHealth intervention boosts adherence to ... Key Points. Hydroxyurea adherence increased by 19.8% with a tailored mHealth intervention in people with SCD and adherence <80%.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8672290/

Preferences for Using a Mobile App in Sickle Cell Disease ... This study explores the preferences regarding a mobile health (mHealth) app to facilitate self-management in adults with SCD and their caregivers living in ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S2949923224000345

Development of the iManage SCD mobile health ... This paper outlines the design and implementation of iManage SCD, a self-management mobile health application for adolescents and young adults (AYA) with sickle ...

8. academic.oup.com academic.oup.com/tbm/article/11/10/1823/6265342

Mobile health use predicts self-efficacy and self-management ... Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease Open Access. Anna M Hood,.