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

Primary Purpose

Grass Pollen Allergy, Rhinoconjunctivitis

Status
Recruiting
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Motivation-enhancing intervention
Standard intervention
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Grass Pollen Allergy focused on measuring Retention, Motivation, Self-Determination Theory, Grass Pollen Allergic Rhinoconjunctivitis, Intralymphatic Immunotherapy, Patient and Public Involvement

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Participants enrolled in the ILIT.NU trial

Exclusion Criteria:

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

Sites / Locations

  • Anne Poder PetersenRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Control

Intervention

Arm Description

Standard reporting method

Web based motivation-enhancing app

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
Motivation
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
10 participants are invited to a focus group interview to discuss their experiences with the web-based app

Full Information

First Posted
September 21, 2022
Last Updated
November 18, 2022
Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Innovation Fund Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05560698
Brief Title
A Motivation-enhancing App to Retain Patients With Hay Fever in a Trial After Treatment
Official Title
A Motivation-enhancing Intervention to Retain Participants in a Trial After Treatment With Allergen Immunotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 26, 2022 (Actual)
Primary Completion Date
August 17, 2023 (Anticipated)
Study Completion Date
August 17, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
Collaborators
Aarhus University Hospital, Innovation Fund Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Grass Pollen Allergy, Rhinoconjunctivitis
Keywords
Retention, Motivation, Self-Determination Theory, Grass Pollen Allergic Rhinoconjunctivitis, Intralymphatic Immunotherapy, Patient and Public Involvement

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Participants are randomized 1:1 across treatment group
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
286 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Other
Arm Description
Standard reporting method
Arm Title
Intervention
Arm Type
Other
Arm Description
Web based motivation-enhancing app
Intervention Type
Other
Intervention Name(s)
Motivation-enhancing intervention
Intervention Description
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 Type
Other
Intervention Name(s)
Standard intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Rate of reporting daily cSMS data
Description
Increased reporting will be compared within and between the intervention group and the control group, to evaluate the effectiveness of the motivation-enhancing intervention
Time Frame
16 weeks
Secondary Outcome Measure Information:
Title
Retention
Description
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
Time Frame
16 weeks
Title
Motivation
Description
Increased motivation measured by the Intrinsic Motivation Inventory Questionnaire, to evaluate the effectiveness of the motivation-enhancing intervention
Time Frame
14 days
Title
Participant experience with the web-based app
Description
10 participants are invited to a focus group interview to discuss their experiences with the web-based app
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Participants enrolled in the ILIT.NU trial Exclusion Criteria: Participants not enrolled in the ILIT.NU trial, Denmark
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jan Elo Jørgensen, PhD
Phone
+45 22186989
Email
jej@clin.au.dk
First Name & Middle Initial & Last Name or Official Title & Degree
Hans Jürgen Hoffmann, PhD
Phone
+45 28188147
Email
hjh@clin.au.dk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Poder Petersen
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Anne Poder Petersen
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne Poder Petersen

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
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.
Links:
URL
http://ilit.nu
Description
Home page for the ILIT.NU trial

Learn more about this trial

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

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