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

NCT05560698 | Completed DMC

• 1 other identifier: 26092022
• Study Type: interventional
• Target: 224
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Grass Pollen Allergy; Rhinoconjunctivitis

Keywords

Retention; Motivation; Self-Determination Theory; Grass Pollen Allergic Rhinoconjunctivitis; Intralymphatic Immunotherapy; Patient and Public Involvement

Outcome Measures

Primary Outcomes (1)

• Rate of reporting daily cSMS data

  Increased reporting will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention

  16 weeks

Secondary Outcomes (3)

• Retention

  16 weeks

• Motivation

  14 days

• Participant experience with the web-based app

  12 weeks

Study Arms (2)

Control

OTHER

Standard reporting method

Other: Standard intervention

Intervention

OTHER

Web based motivation-enhancing app

Other: Motivation-enhancing intervention

Interventions

Motivation-enhancing intervention 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

Intervention

Standard intervention 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.

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants enrolled in the ILIT.NU trial

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• Aarhus University Hospital: collaborator
• Innovation Fund Denmark: collaborator

Study Sites (1)

Anne Poder Petersen

Aarhus, 8200, Denmark

Location

Related Links

• Home page for the ILIT.NU trial

Study Officials

• Anne Poder Petersen

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants are randomized 1:1 across treatment group

Study Record Dates

• First Submitted: September 21, 2022
• First Posted: September 29, 2022
• Study Start: September 26, 2022
• Primary Completion: August 17, 2023
• Study Completion: June 30, 2024
• Last Updated: June 18, 2025

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)