Digital Health Intervention to Promote Quality of Life in Adults With Chronic Graft Versus Host Disease

March 24, 2026 updated by: Lara Traeger, University of Miami
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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • University of Miami

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Underwent allogeneic hematopoietic stem cell transplant
  • Have moderate to severe chronic graft-versus-host disease
  • Currently receiving care at the Sylvester Comprehensive Cancer Center Bone Marrow Transplant Program
  • Able to use an Ipad to participate in the Horizons app intervention
  • Able to participate in study procedures in English

Exclusion Criteria:

  • comorbid conditions or cognitive impairment that the treating clinician believes prohibits informed consent or participation in the intervention
  • Vulnerable patients, defined here as prisoners and pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Horizons Digital Health Application Group
Participants will receive the Horizons mobile application for up to 6 weeks.
Behavioral: Horizons App Intervention
Participants will receive access to the Horizons app intervention. The intervention pairs patient-centered information about chronic graft-versus-host disease with self-management strategies. Within each module, patients will engage in didactics and exercises that are relevant to the participant's chronic graft-versus-host disease concerns. The app contains 6 digital modules delivered via tablet over approximately 6 weeks. Each module should take up to approximately 20 minutes and are self-guided.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of participant enrollment
Time Frame: Up to 8-week follow-up
Participant enrollment will be demonstrated if ≥60% eligible participants enroll.
Up to 8-week follow-up
Percentage of participant retention
Time Frame: Up to 8-week follow-up
Participant retention will be demonstrated if ≥80% participants are retained in the study.
Up to 8-week follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Investigators

  • Principal Investigator: Lara Traeger, PhD, University of Miami

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 4, 2024

Primary Completion (Estimated)

September 25, 2026

Study Completion (Estimated)

September 25, 2026

Study Registration Dates

First Submitted

November 12, 2024

First Submitted That Met QC Criteria

November 12, 2024

First Posted (Actual)

November 14, 2024

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20240864

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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