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A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment

University of Aarhus logo

University of Aarhus

Status

Completed

Conditions

Rhinoconjunctivitis
Grass Pollen Allergy

Treatments

Other: Standard intervention
Other: Motivation-enhancing intervention

Study type

Interventional

Funder types

Other

Identifiers

NCT05560698
26092022

Details and patient eligibility

About

The motivation-enhancing intervention is designed for participants in the ILIT.NU trial. The participants are patients with hay fever who are treated with a vaccination in an inguinal lymph node. The motivation-enhancing intervention is a web-based app developed in collaboration with patient partners and is intended to increase retention and reporting in the ILIT.NU trial.

Full description

The ILIT.NU trial (EudraCT 2020-001060-28) investigates whether patient reported outcome measures compound symptom-medication score (cSMS) are relieved by intralymphatic immunotherapy (ILIT). The participants are asked for a three-year period to attend annual consultations and to daily fill in an online questionnaire about their allergy symptoms and medication use during the grass pollen season (100 days).

High attrition rates have been a problem in previous ILIT trials. High attrition affects generalizability, validity and reliability of a trial. To increase retention and reporting in the ILIT.NU trial, a motivation-enhancing web-based app has been developed. The web app is based on the Self-Determination Theory and is developed in collaboration with patient partners and clinicians. Participants are randomized across treatment group to either the motivation-enhancing web app or the standard reporting method. The project is conducted as a Study Within a Trial (SWAT).

Enrollment

224 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Participants enrolled in the ILIT.NU trial

Exclusion criteria

  • Participants not enrolled in the ILIT.NU trial, Denmark

Trial design

Primary purpose

Other

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

224 participants in 2 patient groups

Control
Other group
Description:
Standard reporting method
Treatment:
Other: Standard intervention
Intervention
Other group
Description:
Web based motivation-enhancing app
Treatment:
Other: Motivation-enhancing intervention

Trial contacts and locations

1

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Central trial contact

Jan Elo Jørgensen, PhD; Hans Jürgen Hoffmann, PhD

Data sourced from clinicaltrials.gov

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