Rheumatoid Arthritis Clinical Trial
— MiDEAROfficial title:
Mobile Medically Supervised Patient Management in Rheumatoid Arthritis Patients Using DocuMed.rh and RheumaLive App
NCT number | NCT02565225 |
Other study ID # | MiDEAR |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | November 2014 |
Est. completion date | July 2016 |
Verified date | September 2023 |
Source | Heinrich-Heine University, Duesseldorf |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 60 |
Est. completion date | July 2016 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - age >= 18 years, owner of App capable device, RA, informed consent Exclusion Criteria: - non German speaking, no App capable device available |
Country | Name | City | State |
---|---|---|---|
Germany | Policlinic for Rheumatology & Hiller Research Centre for Rheumatology | Duesseldorf |
Lead Sponsor | Collaborator |
---|---|
Heinrich-Heine University, Duesseldorf |
Germany,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of use by counting and by a patient paper-based questionnaire | baseline and change over up to nine months | |
Secondary | 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) | baseline and change after 3 months | |
Secondary | Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of feasibility by a patient and a physician paper-based questionnaire | at 3 months from start and change over 6 more months | |
Secondary | Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis. | Evaluation of usability by a patient paper-based questionnaire | at 3 months from start and change over 6 more months |
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