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

NCT ID: NCT05560698

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

224 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-26

Study Completion Date

2024-06-30

Brief Summary

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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.

Detailed Description

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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).

Conditions

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Grass Pollen Allergy Rhinoconjunctivitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants are randomized 1:1 across treatment group
Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Control

Standard reporting method

Group Type OTHER

Standard intervention

Intervention Type OTHER

Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. When the questionnaire is answered, the tab needs to be closed.

Intervention

Web based motivation-enhancing app

Group Type OTHER

Motivation-enhancing intervention

Intervention Type OTHER

The web app is designed as an efficient and easy-to-use app configurable to personal preferences. Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. The questionnaire addresses the same questions as the questionnaire in the standard intervention, but the format is different, and some shortcuts makes it easier to answer. When the questionnaire is answered, the web app gives access to different features. The following features distinct the motivation-enhancing intervention from the standard intervention (1) only complete the entire questionnaire on days with symptoms, (2) integration of grass pollen counts and forecasts, (3) showing personal response rate, (4) access to own data via a graph, (5) advice against grass pollen allergy, (6) status of the study, (7) individually choosing the time of response, (8) option to download an icon for the home screen and (9) contact information. The development is an ongoing iterative process

Interventions

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Motivation-enhancing intervention

The web app is designed as an efficient and easy-to-use app configurable to personal preferences. Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. The questionnaire addresses the same questions as the questionnaire in the standard intervention, but the format is different, and some shortcuts makes it easier to answer. When the questionnaire is answered, the web app gives access to different features. The following features distinct the motivation-enhancing intervention from the standard intervention (1) only complete the entire questionnaire on days with symptoms, (2) integration of grass pollen counts and forecasts, (3) showing personal response rate, (4) access to own data via a graph, (5) advice against grass pollen allergy, (6) status of the study, (7) individually choosing the time of response, (8) option to download an icon for the home screen and (9) contact information. The development is an ongoing iterative process

Intervention Type OTHER

Standard intervention

Each day participants receive a text message on their smartphone with a link for the daily cSMS questionnaire. When the questionnaire is answered, the tab needs to be closed.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Participants enrolled in the ILIT.NU trial

Exclusion Criteria

* Participants not enrolled in the ILIT.NU trial, Denmark
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Aarhus University Hospital

OTHER

Sponsor Role collaborator

Innovation Fund Denmark

INDIV

Sponsor Role collaborator

University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Anne Poder Petersen

Role: PRINCIPAL_INVESTIGATOR

University of Aarhus

Locations

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Anne Poder Petersen

Aarhus, , Denmark

Site Status

Countries

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Denmark

Related Links

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http://ilit.nu

Home page for the ILIT.NU trial

Other Identifiers

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26092022

Identifier Type: -

Identifier Source: org_study_id

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