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A Motivation-enhancing Intervention to Retain Participants in a Trial After Treatment With Allergen Immunotherapy
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.
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).
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
No
Anne Poder Petersen
Aarhus, Denmark
Start Date
September 26, 2022
Primary Completion Date
August 17, 2023
Completion Date
June 30, 2024
Last Updated
June 18, 2025
224
ACTUAL participants
Motivation-enhancing intervention
OTHER
Standard intervention
OTHER
Lead Sponsor
University of Aarhus
Collaborators
NCT04435990
NCT06778213
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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