Grass Pollen AllergyNCT05560698
A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment
A study testing Motivation-enhancing intervention and Standard intervention in people with Grass Pollen Allergy and Rhinoconjunctivitis, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grass Pollen Allergy, Rhinoconjunctivitis
- What is being tested?
- Motivation-enhancing intervention and Standard intervention
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteDenmark
- Study dates
- 26 Sep 2022to 30 Jun 2024
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants enrolled in the ILIT.NU trial
Who cannot join
- Participants not enrolled in the ILIT.NU trial, Denmark
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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).
- Conditions
- Grass Pollen Allergy, Rhinoconjunctivitis
- Being tested
- Motivation-enhancing intervention, Standard intervention
- Keywords
- Retention, Motivation, Self-Determination Theory, Grass Pollen Allergic Rhinoconjunctivitis, Intralymphatic Immunotherapy, Patient and Public Involvement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Motivation-enhancing interventionOther
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 interventionOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Standard reporting method Receives: Other: Standard intervention |
| Intervention | Other | Web based motivation-enhancing app Receives: Other: Motivation-enhancing intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 16 weeks
Secondary outcomes (3)
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
Measured: 16 weeks
Motivation
Increased motivation measured by the Intrinsic Motivation Inventory Questionnaire, to evaluate the effectiveness of the motivation-enhancing intervention
Measured: 14 days
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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2022
- Study start26 Sep 2022
- Primary completion17 Aug 2023
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Grass Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized 1:1 across treatment group
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- Aarhus University Hospital, Innovation Fund Denmark
- Responsible party
- Sponsor
- Investigators
- Anne Poder Petersen, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05560698
- Sponsor's protocol ID
- 26092022
- Status last verified
- Nov 2023
- First submitted
- 21 Sep 2022
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Due to restrictions from GDPR and the Danish National Committee on Health Research Ethics, IPD are not shared with other researchers. Anonymous data may be shared.