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NCT05560698 Clinical Trial

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

Rhinoconjunctivitis Clinical Trial

Official title:
A Motivation-enhancing Intervention to Retain Participants in a Trial After Treatment With Allergen Immunotherapy

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05560698
Other study ID # 26092022
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date September 26, 2022
Est. completion date August 17, 2023

Study information
Verified date September 2022
Source University of Aarhus
Contact Jan Elo Jørgensen, PhD
Phone +45 22186989
Email jej@clin.au.dk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Recruiting
Enrollment 286
Est. completion date August 17, 2023
Est. primary completion date August 17, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Participants enrolled in the ILIT.NU trial Exclusion Criteria: - Participants not enrolled in the ILIT.NU trial, Denmark

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• 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
• 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.

Locations
Country Name City State
Denmark Anne Poder Petersen Aarhus

Sponsors (3)
Lead Sponsor Collaborator
University of Aarhus Aarhus University Hospital, Innovation Fund Denmark

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Retention 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 16 weeks
Secondary Motivation Increased motivation measured by the Intrinsic Motivation Inventory Questionnaire, to evaluate the effectiveness of the motivation-enhancing intervention 14 days
Secondary Participant experience with the web-based app 10 participants are invited to a focus group interview to discuss their experiences with the web-based app 12 weeks
See also
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Completed NCT00540631 - Multicenter Trial of Immunotherapy With House Dust Mite Allergoid Phase 3
Completed NCT00537342 - Immunotherapy With Depigmented and Polymerized Allergen Extract of Olea Europaea (GPIT) Phase 3
Completed NCT00574210 - PK/PD and Steady State Efficacy Study of Bilastine Compared With Placebo Given Orally in the Treatment of the Symptoms of SAR in an EEC Model (5-arm) Phase 2
Completed NCT05540717 - Efficacy and Safety of PQ Grass in Subjects With Seasonal Allergic Rhinitis and/or Rhinoconjunctivitis Induced by Grass Pollen Phase 3
Completed NCT02844842 - Evaluation of Tolerability and Safety of "Allergovac Poliplus" in Polysensitized Patients With Rhinitis or Allergic Rhinoconjunctivitis With or Without Asthma: A Study in Daily Clinical Practice
Completed NCT01734265 - Safety Clinical Trial With Depigopid 50% Grasses/50% Olea Europaea(2000DPP/ml) or Depigoid 50% Grasses/50% Parietaria Judaica(2000DPP/ml). Phase 2

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