Development and early prototype testing of the cGvHD module as part of the SMILe-ICM (Integrated Care Model (ICM) for allogeneic SteM Cell TransplantatIon faciLitated by eHealth (SMILe) – in chronic Graft-versus-Host-Disease (cGvhD))

Development and early prototype testing of the cGvHD module as part of the SMILe-ICM (Integrated Care Model (ICM) for allogeneic SteM Cell TransplantatIon faciLitated by eHealth (SMILe) – in chronic Graft-versus-Host-Disease (cGvhD)) - SMILe-cGvHD

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00035022

Enrollment

Registered

2024-11-14

Start date

2024-11-11

Completion date

Unknown

Last updated

2025-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic Graft-versus-Host-Disease (cGvHD)

Interventions

Group 1: The study involves three consecutive working packages: 1. Individual interviews with patients (single session of 60 minutes), focus groups with clinical professionals (single session of 60 mi

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: History of acute GvHD grade II–IV and/or FEV1 = 80% of predicted value on day +100 ±15 after alloSCT. Sufficient concentration and cognitive abilities to engage in a 60-minute conversation, follow complex instructions, and communicate about them. Adequate proficiency in German. For focus groups only: Healthcare professionals with completed vocational training and at least two years of professional experience in the care of patients with cGvHD within the German healthcare system.

Exclusion criteria

Exclusion criteria: Individuals unable to provide informed consent. Language barriers that significantly impede understanding of the presented content and communication about it. For focus groups only: Healthcare professionals with a conflict of interest.

Design outcomes

Primary

Measure	Time frame
Overarching Goal: Improvement of care for patients with cGvHD.	—

Secondary

Measure	Time frame
1. Assessment of the Current Care Setting: Understanding the current care environment, patient needs, and care requirements from the perspective of healthcare professionals at the start of the project through a context analysis involving patient interviews and focus groups with healthcare professionals. 2. Development of a Functional Prototype: Creation of a working prototype of the cGvHD module with the identified functionalities and technical interface for home spirometry devices, evaluated through user tests using video recordings, unstructured interviews, quantitative data from the System Usability Scale (SUS), and documentation, analysis, and prioritization of feedback. 3. User friendliness, feasibility, acceptability, and adherence: Measurement from the patient perspective during a one-year pilot phase, using usage data, qualitative interviews, and questionnaires (FIM/AIM/IAM = Feasibility of Intervention Measure/Acceptance of Intervention Measure/Intervention Appropriateness Measure) at d+120, d+150, d+180, d+365 and, in case of active cGvHD or continuation of immunosuppression, up to d+545.	—

Measure

Time frame

1. Assessment of the Current Care Setting: Understanding the current care environment, patient needs, and care requirements from the perspective of healthcare professionals at the start of the project through a context analysis involving patient interviews and focus groups with healthcare professionals. 2. Development of a Functional Prototype: Creation of a working prototype of the cGvHD module with the identified functionalities and technical interface for home spirometry devices, evaluated through user tests using video recordings, unstructured interviews, quantitative data from the System Usability Scale (SUS), and documentation, analysis, and prioritization of feedback. 3. User friendliness, feasibility, acceptability, and adherence: Measurement from the patient perspective during a one-year pilot phase, using usage data, qualitative interviews, and questionnaires (FIM/AIM/IAM = Feasibility of Intervention Measure/Acceptance of Intervention Measure/Intervention Appropriateness Measure) at d+120, d+150, d+180, d+365 and, in case of active cGvHD or continuation of immunosuppression, up to d+545.

—

Countries

Germany

Contacts

Public ContactLynn Leppla

Universitätsklinik Freiburg, Klinik für Innere Medizin 1

lynn.leppla@uniklinik-freiburg.de+49 761 270 34190

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026