Rheumatoid ArthritisMiDEARNCT02565225
Mobile Medically Supervised Patient Management in Rheumatoid Arthritis
An observational study of Rheumatoid Arthritis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial summary
The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- RheumaLive App use
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2014to Jul 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
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
Study population: RA patients
Who may be able to join
- age >= 18 years, owner of App capable device, RA, informed consent
Who cannot join
- non German speaking, no App capable device available
Trial locations and contacts
1 site in 1 country.
Germany1 site
Policlinic for Rheumatology & Hiller Research Centre for Rheumatology
Düsseldorf, 40225
About this study
Official title: Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App
The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.
- Conditions
- Rheumatoid Arthritis
- Being tested
- RheumaLive App use
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RheumaLive App useBehavioural
| Study group | Role | What they receive |
|---|---|---|
| RheumaLive App use | RheumaLive App use and evaluation of feasibility Receives: Behavioral: RheumaLive App use | |
| RheumaLive App use & threshold values | RheumaLive App use and evaluation of feasibility Receives: Behavioral: RheumaLive App use |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis.
Evaluation of use by counting and by a patient paper-based questionnaire
Measured: baseline and change over up to nine months
Secondary outcomes (3)
Comparison paper-based vs electronic PROM in the App - Differences of the scores
RADAI - Rheumatoid Arthritis Disease Activity Index and FFbH (Hannover Functional Ability Questionnaire ) / calculated HAQ (Health Assesment Questionnaire)
Measured: baseline and change after 3 months
Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis.
Evaluation of feasibility by a patient and a physician paper-based questionnaire
Measured: at 3 months from start and change over 6 more months
Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.
Evaluation of usability by a patient paper-based questionnaire
Measured: at 3 months from start and change over 6 more months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2015 (estimated)
- Study startNov 2014
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthias Schneider, Prof., Principal investigator, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02565225
- Sponsor's protocol ID
- MiDEAR
- Acronym
- MiDEAR
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2015
- Last updated
- 26 Sep 2023
- Results posted
- No
Publications
Richter JG, Nannen C, Chehab G, Acar H, Becker A, Willers R, Huscher D, Schneider M. Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. Arthritis Res Ther. 2021 Apr 19;23(1):121. doi: 10.1186/s13075-021-02500-3.
PubMed 33874994
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App
- ClinicalTrials.gov ID
- NCT02565225
- Acronym / sponsor ID
- MiDEAR / MiDEAR
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 1 Oct 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the use, usability and feasibility of an Application (App) for patients with rheumatoid arthritis with diary functionalities, in patient-physician interaction.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RheumaLive App use | – | Behavioral: RheumaLive App useRheumaLive App use and evaluation of feasibility |
| RheumaLive App use & threshold values | – | Behavioral: RheumaLive App useRheumaLive App use and evaluation of feasibility |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- RA patients
Key inclusion criteria (1 listed)
- age >= 18 years, owner of App capable device, RA, informed consent
Key exclusion criteria (1 listed)
- non German speaking, no App capable device available
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RheumaLive App use | Behavioural | RheumaLive App use, RheumaLive App use & threshold values |
Primary outcome
Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis.
Time frame: baseline and change over up to nine months
Evaluation of use by counting and by a patient paper-based questionnaire
3 secondary outcomes
Comparison paper-based vs electronic PROM in the App - Differences of the scores
Time frame: baseline and change after 3 months
Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis.
Time frame: at 3 months from start and change over 6 more months
Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.
Time frame: at 3 months from start and change over 6 more months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2023.
- Derived from this study: PubMed 33874994Richter JG, Nannen C, Chehab G, Acar H, Becker A, Willers R, Huscher D, Schneider M. Mobile App-based documentation of patient-reported outcomes - 3-months results from a proof-of-concept study on modern rheumatology patient management. Arthritis Res Ther. 2021 Apr 19;23(1):121. doi: 10.1186/s13075-021-02500-3.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthias Schneider, Prof. principal investigator
Heinrich-Heine University, Duesseldorf
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis. (time frame: baseline and change over up to nine months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02565225, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Sep 2023.