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

Not Applicable

Recruiting

• Conditions: Rhinoconjunctivitis; Grass Pollen Allergy
• Interventions: Other: Standard intervention; Other: Motivation-enhancing intervention

• Registration Number: NCT05560698
• Lead Sponsor: University of Aarhus

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.

Detailed 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).

Study Timeline

• Status Verified: 2022-09
• Study First Submitted: 2022-09-21
• Study Start: 2022-09-26
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-29
• Last Update Submitted: 2022-11-18
• Last Update Posted: 2022-11-21
• Primary Completion: 2023-08-17
• Study Completion: 2023-08-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 286

Inclusion Criteria

• Participants enrolled in the ILIT.NU trial

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Standard intervention	Standard reporting method
Intervention	Motivation-enhancing intervention	Web based motivation-enhancing app

Primary Outcome Measures

Name	Time	Method
Rate of reporting daily cSMS data	16 weeks	Increased reporting will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention

Secondary Outcome Measures

Name	Time	Method
Motivation	14 days	Increased motivation measured by the Intrinsic Motivation Inventory Questionnaire, to evaluate the effectiveness of the motivation-enhancing intervention
Participant experience with the web-based app	12 weeks	10 participants are invited to a focus group interview to discuss their experiences with the web-based app
Retention	16 weeks	Increased retention measured as loss to follow up, where drop outs from the ILIT.NU trial will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention

Trial Locations

Locations (1)

Anne Poder Petersen; 🇩🇰 Aarhus, Denmark