Digital Health Intervention for Graft-versus-Host Disease

Overseen By Hanna Culang, MA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Miami

Disqualifiers: Cognitive impairment, Prisoners, Pregnant women, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

20 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 study team or your doctor.

What data supports the effectiveness of the Horizons App Intervention for treating graft-versus-host disease?

Research shows that digital health tools, like the eGVHD App, improve the accuracy and consistency of assessing graft-versus-host disease (GVHD) severity, which can help in better managing the condition. Additionally, mobile health platforms have been found to be cost-effective and well-received by patients and healthcare professionals, suggesting that similar digital interventions could be beneficial for GVHD treatment. ^{1 2 3 4 5}

Is the Horizons App Intervention safe for humans?

The MY-Medula app, a similar digital health intervention, was tested in a pilot study with stem cell transplant recipients and showed high satisfaction among users, with no reported safety issues. This suggests that digital health interventions like the Horizons App are generally safe for human use. ^{1 2 4 6 7}

How is the Horizons App Intervention for graft-versus-host disease different from other treatments?

The Horizons App Intervention is unique because it uses digital health technology to support patients with graft-versus-host disease, focusing on improving medication adherence and symptom management through a user-friendly app. This approach is novel compared to traditional treatments, which typically involve direct medical interventions without the integration of digital tools for patient engagement and self-management. ^{1 2 3 4 8}

What is the purpose of this trial?

The goal of this interventional study is to learn if the Horizons mobile application is feasible for survivors of allogeneic hematopoietic stem cell transplant who have chronic graft-versus-host disease. Participants will be asked to complete surveys and use the Horizons mobile application.

Research Team

Lara Traeger, PhD

Principal Investigator

University of Miami

Eligibility Criteria

This trial is for survivors of allogeneic hematopoietic stem cell transplant who are living with chronic graft-versus-host disease. Participants should be willing to complete surveys and use the Horizons mobile application.

Inclusion Criteria

I can communicate and understand English for study needs.

I have had a stem cell transplant from a donor.

I have moderate to severe chronic graft-versus-host disease.

Exclusion Criteria

Vulnerable patients, defined here as prisoners and pregnant women

Comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the Horizons mobile application and complete surveys

6 weeks

Follow-up

Participants are monitored for retention and enrollment metrics

8 weeks

Treatment Details

Interventions

• Horizons App Intervention

Trial Overview The study is testing whether the Horizons app can help improve quality of life for people with chronic graft-versus-host disease after a stem cell transplant. It involves using the app and completing surveys about their experience.

Participant Groups

Group I: Horizons Digital Health Application Group Experimental Treatment 1 Intervention

Participants will receive the Horizons mobile application for up to 6 weeks.

Who Is Running the Clinical Trial?

University of Miami

Lead Sponsor

Trials

976

Recruited

423,000+

Findings from Research

The eGVHD App significantly reduces discrepancies in scoring the severity of chronic graft-versus-host disease (GVHD), with a 38% discrepancy rate compared to 9% for acute GVHD when not using the App, highlighting its effectiveness in standardizing assessments.

User satisfaction with the eGVHD App is high, as indicated by median scores of 6 for perceived usefulness and 2 for usability, making it a valuable tool for managing GVHD in bone marrow transplant centers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of eGVHD App for bedside GVHD assessment in a high-volume BMT center. Chhabra, P., Kasudhan, KS., Khaire, N., et al.[2023]

A new web-based data entry system has been developed to standardize the clinical staging of acute graft-versus-host disease (GVHD) across multiple bone marrow transplant centers, addressing significant variability in practices.

This user-friendly system improves accuracy in documenting symptoms and therapeutic responses, which can enhance the quality of data collected in multicenter trials aimed at preventing and treating acute GVHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved accuracy of acute graft-versus-host disease staging among multiple centers. Levine, JE., Hogan, WJ., Harris, AC., et al.[2018]

A new intervention module was developed to improve medication adherence for patients undergoing allogeneic stem cell transplantation, focusing on the implementation and persistence phases of adherence using a structured approach based on behavior change theories.

The intervention identified key behaviors and barriers related to immunosuppressant use, and selected specific strategies like education and goal setting to enhance adherence, which could serve as a model for future eHealth solutions in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. Ribaut, J., Leppla, L., Teynor, A., et al.[2021]

The MY-Medula mHealth platform was successfully implemented in a pilot study with 28 allogeneic stem cell transplantation (allo-SCT) recipients, showing high usability with a median of 143 app visits per patient over 2 months.

Patients and healthcare professionals reported high satisfaction rates (95% and 100%, respectively) with the integrated care model, indicating that mHealth tools can enhance follow-up care for allo-SCT recipients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. Redondo, S., De Dios, A., Gomis-Pastor, M., et al.[2023]

In a retrospective analysis of a randomized clinical trial involving patients undergoing hematopoietic cell transplantation, tacrolimus/methotrexate showed less skin morbidity and a trend toward less liver morbidity compared to cyclosporine/methotrexate, indicating potential benefits in managing acute graft-versus-host disease (GVHD).

Despite these findings, the study highlighted that objective assessments of morbidity related to GVHD have limited utility in demonstrating clinical benefits, emphasizing the need for blinded assessments in future trials to better evaluate treatment efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Longitudinal assessment of morbidity and acute graft-versus-host disease after allogeneic hematopoietic cell transplantation: retrospective analysis of a multicenter phase III study. Carnevale-Schianca, F., Leisenring, W., Martin, PJ., et al.[2021]

In a survey of 1377 allogeneic hematopoietic cell transplant survivors, those with moderate to severe chronic graft-versus-host disease reported significantly worse quality of life and higher symptom burden compared to those whose condition had resolved or who never had it.

A notable percentage (26.7-39.4%) of patients with active chronic graft-versus-host disease were unable to work due to health issues, highlighting the need for improved prevention and treatment strategies to enhance survivorship after transplantation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. Lee, SJ., Onstad, L., Chow, EJ., et al.[2019]

This study evaluated six different strategies for preventing graft-versus-host disease (GVHD) after hematopoietic cell transplantation (HCT) by comparing their effectiveness against a large multicenter outcomes database, highlighting the importance of using comprehensive data for selecting promising interventions.

The research introduced novel composite endpoints, such as graft-versus-host disease, relapse-free survival (GRFS), and chronic GVHD, relapse-free survival (CRFS), which can enhance the design of future clinical trials aimed at improving GVHD prevention strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Blood and Marrow Transplant Clinical Trials Network Report on the Development of Novel Endpoints and Selection of Promising Approaches for Graft-versus-Host Disease Prevention Trials. Pasquini, MC., Logan, B., Jones, RJ., et al.[2021]

The Lee Chronic Graft-versus-Host Disease (cGVHD) Symptom Scale is a reliable and valid tool for capturing cGVHD symptoms, as confirmed by a study involving 20 adult patients with varying severity of the condition.

Participants found the scale to be clear and comprehensive, although some suggested improvements for specific skin-related items and the recall period for symptoms, indicating ongoing refinement is needed for optimal use in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews. Merkel, EC., Mitchell, SA., Lee, SJ.[2019]

References

1. Japan pubmed.ncbi.nlm.nih.gov

Utility of eGVHD App for bedside GVHD assessment in a high-volume BMT center. [2023]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Improved accuracy of acute graft-versus-host disease staging among multiple centers. [2018]

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

Theory-driven development of a medication adherence intervention delivered by eHealth and transplant team in allogeneic stem cell transplantation: the SMILe implementation science project. [2021]

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

Feasibility of a New Model of Care for Allogeneic Stem Cell Transplantation Recipients Facilitated by eHealth: The MY-Medula Pilot Study. [2023]

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

Longitudinal assessment of morbidity and acute graft-versus-host disease after allogeneic hematopoietic cell transplantation: retrospective analysis of a multicenter phase III study. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Patient-reported outcomes and health status associated with chronic graft-versus-host disease. [2019]

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

Blood and Marrow Transplant Clinical Trials Network Report on the Development of Novel Endpoints and Selection of Promising Approaches for Graft-versus-Host Disease Prevention Trials. [2021]

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

Content Validity of the Lee Chronic Graft-versus-Host Disease Symptom Scale as Assessed by Cognitive Interviews. [2019]