Effect of a mobile application on disease activity control in inflammatory arthritis
| ISRCTN | ISRCTN17343801 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17343801 |
- Submission date
- 02/02/2024
- Registration date
- 21/02/2024
- Last edited
- 05/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
Plain English summary of protocol
Background and study aims
Mobile applications (apps) are a major resource for information on lifestyle and general health. A healthy lifestyle is associated with improved outcomes in inflammatory arthritis. Within the MeRLiN study (Meerbuscher Lebensqualitätsstudie zu Rheuma, Lebensstil und Impfungen), the researchers therefore assessed whether targeted lifestyle counselling via an app could improve disease activity in arthritis patients. The aim of this study is to assess whether disease activity in inflammatory arthritis is improved by lifestyle counselling via an app.
Who can participate?
Patients aged over 18 years with inflammatory arthritis (such as rheumatoid arthritis, psoriatic arthritis, spondylarthritis)
What does the study involve?
Patients are alternatingly randomly allocated to either report health-related quality of life only, or to additionally receive 12 weeks of individualized lifestyle counselling via the app about a healthy Mediterranean diet, sports and physical activity, mental health, and non-smoking.
What are the possible benefits and risks of participating?
Participants may benefit from improved disease control in addition to standard of care. There are no foreseen risks.
Where is the study run from?
St Elisabeth Hospital Meerbusch-Lank (Germany)
When is the study starting and how long is it expected to run for?
January 2021 to May 2024
Who is funding the study?
The German Society for Rheumatology (Germany)
Who is the main contact?
Dr Türker Kurt, tuerker.kurt@rrz-meerbusch.de
Contact information
Principal Investigator
Hauptstr. 74-76
Meerbusch
40668
Germany
 ORCID ID |
0000-0001-5725-5483 |
|---|---|
| Phone | +49 (0)2150/9170 |
| stefan.vordenbaeumen@rrz-meerbusch.de |
Public, Scientific
Hauptstr. 74-76
Meerbusch
40668
Germany
| ORCID ID |
0000-0002-5801-630X |
|---|---|
| Phone | +49 (0)2150/9170 |
| tuerker.kurt@rrz-meerbusch.de |
Study information
| Study design | Multicenter interventional double-blinded randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Home, Hospital |
| Study type | Quality of life, Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | Effect of a mobile application on disease activity control in inflammatory arthritis: a randomized controlled pilot study from the "MEerbuscher Lebensqualitätsstudie zu Rheuma, Lebensstil und ImpfungeN" (MERLIN) |
| Study acronym | MERLIN |
| Study objectives | Mobile application with lifestyle counseling improves disease activity control in inflammatory arthritis. |
| Ethics approval(s) |
Approved 10/06/2021, Ethics committee of the Medical Faculty of Heinrich-Heine-University Düsseldorf (Ethikkommission an der Med. Fakultät der HHU, Moorenstr. 5, Düsseldorf, 40225, Germany; +49 (0)21181-19591; ethikkomission@med.uni-duesseldorf.de), ref: 2021-1408 |
| Health condition(s) or problem(s) studied | Inflammatory arthritis: rheumatoid arthritis, psoriatic arthritis, spondyloarthritis |
| Intervention | Patients were alternatingly randomized to either report health-related quality of life (HRQoL) only, or to additionally receive 12 weeks of individualized lifestyle counselling via the app pertaining to a healthy Mediterranean diet, sports and physical activity, mental health, and non-smoking. |
| Intervention type | Behavioural |
| Primary outcome measure | Low disease activity or remission, categorized according to disease-specific instruments: Rheumatoid Arthritis Disease Activity Index (RADAI) for rheumatoid arthritis, Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) for axial spondyloarthritis and Disease Activity Index in Psoriatic Arthritis (DAPSA) for PsoA at baseline and 12 weeks. |
| Secondary outcome measures | 1. Adherence to a healthy Mediterranean diet measured using the Mediterranean Diet Adherence Screener (MEDAS) at weeks 0 and 12 2. Health-related quality of life measured with the Short-Form Health Survey (SF-36) at weeks 0 and 12 3. Weight (in kg) measured using a scale at weeks 0 and 12 4. Self-estimated time doing sports per week (in h) measured using a questionnaire via mobile phone application at weeks 0 and 12 5. Exercise per week measured using BSA (Bewegungs- und Sportaktivität Fragebogen = Movement and sports activity questionnaire) via mobile phone application at weeks 0 and 12 6. Mental health status measured using the Patient Health Questionnaire 5 (PHQ-5) questionnaire via mobile phone application at weeks 0 and 12 7. Rheumatoid arthritis disease activity measured using the compound Disease Activity Score-28 (DAS-28) during patient visit in a subgroup of rheumatoid arthritis (RA) patients at weeks 0 and 12 |
| Overall study start date | 22/01/2021 |
| Completion date | 31/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 99 Years |
| Sex | Both |
| Target number of participants | 150 |
| Total final enrolment | 170 |
| Key inclusion criteria | 1. Patients with inflammatory arthritis: 1.1. Rheumatoid arthritis according to the 2010 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) criteria 1.2. Psoriatic arthritis according to Classification Criteria for Psoriatic Arthritis (CASPAR) criteria 1.3. Spondylarthritis according to Ankylosing Spondylitis Disease Activity Score (ASDAS) criteria 2. Age >18 years 3. Written consent |
| Key exclusion criteria | 1. Patients without written consent 2. Age <18 years 3. Unable to use mobile phone/not in possession of mobile phone |
| Date of first enrolment | 01/06/2022 |
| Date of final enrolment | 31/05/2023 |
Locations
Countries of recruitment
- Germany
Study participating centres
Meerbusch
40668
Germany
Cologne
51149
Germany
Sponsor information
Other
Wilhelmine-Gemberg-Weg 6, Aufgang C
Berlin
10179
Germany
| Phone | +49 (0)30 24 04 84 70 |
|---|---|
| info@dgrh.de | |
| Website | https://dgrh.de |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/08/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer reviewed journal. |
| IPD sharing plan | The statistical analysis report generated and analyzed during the current study is available upon reasonable request from Dr Türker Kurt (tuerker.kurt@rrz-meerbusch.de) after the publication of the data, excluding data potentially permitting patient identification such as date of birth or date of visits, thereby precluding the necessity for participants’ consent in accordance with ethical restrictions. Legal restrictions may apply concerning patent law aspects, which will be checked following requests. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 14/05/2024 | 20/08/2024 | Yes | No |
Editorial Notes
05/12/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2024 to 31/05/2024.
2. The total final enrolment was changed from 158 to 170.
20/08/2024: Publication reference added.
02/02/2024: Study's existence confirmed by the Ethics committee of the Medical Faculty of Heinrich-Heine-University Düsseldorf.
