Viewing Study NCT04365842



Ignite Creation Date: 2024-05-06 @ 2:35 PM
Last Modification Date: 2024-10-26 @ 1:33 PM
Study NCT ID: NCT04365842
Status: UNKNOWN
Last Update Posted: 2020-04-28
First Post: 2020-04-15

Brief Title: Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis
Sponsor: Marmara University
Organization: Marmara University

Study Overview

Official Title: Development Feasibility and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis Mix Method Study
Status: UNKNOWN
Status Verified Date: 2020-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: Growing research evidence supports the effectiveness of mHealth interventions for improving exercise adherence and motivation The aims of our study are 1 to develop and design a smartphone application for a structured hand exercise program for patients with RA and to test its usability 2 Evaluate the feasibility and effectiveness of hand exercise app This study is a mixed-methods study that aims to investigate the effectiveness of the Mar-HandTherapy app a qualitative and quantitative study with the iterative design approach
Detailed Description: The long-term beneficial effects of strengthening and stretching for rheumatoid arthritis RA for hand programs SARAH on functions have been shown in recent studies Also recently a usable web-based hand exercise program developed for patients with RA in UK 1- The aim of our study is to develop and design a smartphone application for structured hand exercise program for patients with RA and to test its usability 2- Evaluate the feasibility and effectiveness of smartphone app hand exercise app In our study a qualitative iterative design approach that includes focus groups of expertspatients was used The mobile application was designed in 3 phases PHASE 1 we conducted focus group meetings to compromise the content feature and design of app in the first phase Prototype version of smartphone software for RA hand training programMar-Hand-Therapy app Focus Group were consisted two physiotherapist PT three hand therapists HT working in the field in different rheumatology or hand rehabilitation clinics two software-computer engineers 3 patients with RA who had previously participated hand therapy All focus group members n10 and 6 patients used the app for one week All users filled the usability questionnaire made the comments and advises The revised version was tested again for one week The last revised version completed after two weeks tested 40 patients diagnosed with rheumatoid arthritis will be included to the study Participants randomized to digital intervention and waiting list control After the 6-week digital intervention qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention The primary outcomes are hand pain and function and exercise adherence

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None