NCT02565225

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2015

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 1, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

September 26, 2023

Status Verified

September 1, 2023

Enrollment Period

1.7 years

First QC Date

September 16, 2015

Last Update Submit

September 25, 2023

Conditions

Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Comparison paper-based vs electronic PROM in the App - Differences of the scores

    baseline and change after 3 months

  • Evaluation of feasibility of the RheumaLive Application in patients with rheumatoid arthritis.

    at 3 months from start and change over 6 more months

  • Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.

    at 3 months from start and change over 6 more months

Study Arms (2)

RheumaLive App use

RheumaLive App use and evaluation of feasibility

Behavioral: RheumaLive App use

RheumaLive App use & threshold values

RheumaLive App use and evaluation of feasibility

Behavioral: RheumaLive App use

Interventions

RheumaLive App useBEHAVIORAL
RheumaLive App useRheumaLive App use & threshold values

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

RA patients

You may qualify if:

  • age \>= 18 years, owner of App capable device, RA, informed consent

You may not qualify if:

  • non German speaking, no App capable device available

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinic for Rheumatology & Hiller Research Centre for Rheumatology

Düsseldorf, 40225, Germany

Location

Related Publications (1)

  • 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.

    PMID: 33874994DERIVED

MeSH Terms

Conditions

Arthritis, Rheumatoid

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic DiseasesConnective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Matthias Schneider, Prof.

    Heinrich-Heine University, Duesseldorf

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2015

First Posted

October 1, 2015

Study Start

November 1, 2014

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

September 26, 2023

Record last verified: 2023-09

Locations

DE(1)