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Active, Not Recruiting

NCT Number: NCT06688942

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Chronic Graft-versus-host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Quality of Life Respiratory Tract Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Miami

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Horizons App Intervention

Behavioral

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.

Primary outcomes

  1. Percentage of participant enrollment

    Time frame: Up to 8-week follow-up

    Participant enrollment will be demonstrated if ≥60% eligible participants enroll.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Nov 14, 2024
Registry last updated
Mar 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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