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

Sponsor

University of Aarhus (Other)

Overall Status

Recruiting

CT.gov ID

NCT05560698

Collaborator

Aarhus University Hospital (Other), Innovation Fund Denmark (Other)

286

Enrollment

Location

Arms

10.7

Anticipated Duration (Months)

26.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Grass Pollen Allergy Rhinoconjunctivitis	Other: Motivation-enhancing intervention Other: Standard intervention	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

286 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Participants are randomized 1:1 across treatment groupParticipants are randomized 1:1 across treatment group

Masking:

Double (Investigator, Outcomes Assessor)

Primary Purpose:

Other

Official Title:

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

Actual Study Start Date :

Sep 26, 2022

Anticipated Primary Completion Date :

Aug 17, 2023

Anticipated Study Completion Date :

Aug 17, 2023

Arms and Interventions

Arm	Intervention/Treatment
Other: Control Standard reporting method	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.
Other: Intervention Web based motivation-enhancing app	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

Arm

Intervention/Treatment

Other: Control

Standard reporting method

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.

Other: Intervention

Web based motivation-enhancing app

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

Outcome Measures

Primary Outcome Measures

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

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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Participants enrolled in the ILIT.NU trial

Exclusion Criteria:

Participants not enrolled in the ILIT.NU trial, Denmark

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Anne Poder Petersen	Aarhus		Denmark	8200

Sponsors and Collaborators

University of Aarhus
Aarhus University Hospital
Innovation Fund Denmark

Investigators

Principal Investigator: Anne Poder Petersen, University of Aarhus

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Home page for the ILIT.NU trial

Publications

None provided.

Responsible Party:

University of Aarhus

ClinicalTrials.gov Identifier:

NCT05560698

Other Study ID Numbers:

26092022

First Posted:

Sep 29, 2022

Last Update Posted:

Nov 21, 2022

Last Verified:

Sep 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by University of Aarhus

Retention

Motivation

Self-Determination Theory

Grass Pollen Allergic Rhinoconjunctivitis

Intralymphatic Immunotherapy

Patient and Public Involvement

Additional relevant MeSH terms:

Rhinitis, Allergic, Seasonal

Study Results

No Results Posted as of Nov 21, 2022