Mobile Medically Supervised Patient Management in Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Behavioral: RheumaLive App use

• Registration Number: NCT02565225
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-11
• Study First Submitted: 2015-09-16
• Study First Submitted QC: 2015-09-30
• Study First Posted: 2015-10-01
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-25
• Last Update Posted: 2023-09-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

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

Exclusion Criteria

• non German speaking, no App capable device available

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
RheumaLive App use & threshold values	RheumaLive App use	RheumaLive App use and evaluation of feasibility
RheumaLive App use	RheumaLive App use	RheumaLive App use and evaluation of feasibility

Primary Outcome Measures

Name	Time	Method
Evaluation of use of the RheumaLive Application in patients with rheumatoid arthritis.	baseline and change over up to nine months	Evaluation of use by counting and by a patient paper-based questionnaire

Secondary Outcome Measures

Name	Time	Method
Comparison paper-based vs electronic PROM in the App - Differences of the scores	baseline and change after 3 months	RADAI - Rheumatoid Arthritis Disease Activity Index and FFbH (Hannover Functional Ability Questionnaire ) / calculated HAQ (Health Assesment Questionnaire)
Evaluation of usability of the RheumaLive Application in patients with rheumatoid arthritis.	at 3 months from start and change over 6 more months	Evaluation of usability by a patient paper-based questionnaire
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 feasibility by a patient and a physician paper-based questionnaire

Trial Locations

Locations (1)

Policlinic for Rheumatology & Hiller Research Centre for Rheumatology; 🇩🇪 Duesseldorf, Germany