mHealth App + Booklets for Sickle Cell Disease

(PF-Guide Trial)

Recruiting at 3 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

287 Participants Needed

Trial Summary

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 data supports the effectiveness of the mHealth app + booklets treatment for sickle cell disease?

Research shows that using a mobile health app can help people with sickle cell disease manage their symptoms better, improve their mood, and reduce pain. People who used the app more often reported feeling more in control of their health and had better self-management skills. ^{1 2 3 4 5}

Is the mHealth app + booklets treatment generally safe for humans?

Research on mobile health apps for reporting adverse events, like those used for vaccines and drug reactions, suggests they are generally safe and well-accepted by users. These apps help monitor and report any side effects, ensuring timely communication between patients and healthcare providers. ^{6 7 8 9 10}

How does the mHealth app + booklets treatment for sickle cell disease differ from other treatments?

The mHealth app + booklets treatment is unique because it combines a mobile app with educational booklets to help patients manage sickle cell disease by improving their knowledge and self-management skills. This approach leverages technology to provide patient-friendly guidelines and support, which is different from traditional treatments that may not focus on self-management or use digital tools. ^{2 3 4 11 12}

What is the purpose of this trial?

In a hybrid type I effectiveness-implementation trial, our three-center research teams aim to examine whether empowering adults with sickle cell disease (SCD) with patient-facing SCD-specific guidelines through an mHealth application with booklets will decrease acute healthcare utilization and be cost-effective over booklets with the guidelines alone. Our team, head will test our hypotheses with the following aims: Aim 1: evaluate the effectiveness of the patient-facing guidelines mHealth app + booklet intervention to decrease acute healthcare utilization (hospitalizations, emergency room visits, and day hospital visits) in adults with SCD over the standard care in a randomized controlled trial, Aim 2: evaluate the implementation outcomes of the mHealth app + booklet using the capability, opportunity, and motivation-behavior (COM-B) and reach, effectiveness, adoption, implementation, and maintenance (RE-AIM) frameworks, and Aim 3: evaluate the cost-effectiveness of patient-facing mHealth app + booklets vs. standard care in adults with SCD. is hybrid effectiveness-implementation trial design, according to the COM-B and RE-AIM frameworks with a mixed-methods approach, will give valuable insights into the effects, facilitators, and barriers to the implementation that will influence the effects of the patient-facing guidelines intervention.

Research Team

Robert M Cronin, MD, MS

Principal Investigator

Ohio State University

Eligibility Criteria

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

I have been diagnosed with sickle cell disease.

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

I am over 18 years old.

Timeline

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Mobile health use predicts self-efficacy and self-management in adolescents with sickle cell disease. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Development and evaluation of iManage: A self-management app co-designed by adolescents with sickle cell disease. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Patients welcome the Sickle Cell Disease Mobile Application to Record Symptoms via Technology (SMART). [2022]

4. United States pubmed.ncbi.nlm.nih.gov

A feasibility randomized controlled trial of an mHealth app vs booklets for patient-facing guidelines in adults with SCD. [2023]

5. England 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). [2022]

6. Australia pubmed.ncbi.nlm.nih.gov

Using automated text messages to monitor adverse events following immunisation in general practice. [2022]

7. Germany pubmed.ncbi.nlm.nih.gov

User preferences for a mobile application to report adverse events following vaccination. [2020]

8. New Zealand 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. [2022]

9. United States 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. [2022]

10. New Zealand 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. [2019]

11. Canada pubmed.ncbi.nlm.nih.gov

Preferences for Using a Mobile App in Sickle Cell Disease Self-management: Descriptive Qualitative Study. [2022]

12. Netherlands pubmed.ncbi.nlm.nih.gov

Exploring the Challenges and Opportunities of eHealth Tools for Patients with Sickle Cell Disease. [2018]