跳至主要内容
临床试验/NCT04365842
NCT04365842Unknown不适用

Development, Feasibility, and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis: Mix Method Study

Marmara University2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年11月2日最近更新:
适应症

试验速览

阶段
不适用
入组人数
40
试验地点
2
主要终点
Change from baseline of Hand pain at 7 week

研究概览

简要总结

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.

详细描述

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 experts/patients 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 program/Mar-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 (n=10) 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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Those diagnosed with rheumatoid arthritis according to ARA criteria
  • RA patients with stage 2 or 3 according to ACR criteria
  • The first symptoms started at least a year ago and those who are undergoing medical treatment
  • Those between the ages of 18-65

排除标准

  • Those who are in the inflammatory period
  • Those who have had surgery for neurological, orthopedic or other reasons recently
  • Those with specified depression or other psychological diagnosis
  • Those who have received physiotherapy and ergotherapy in the past year

结局指标

主要结局

Change from baseline of Hand pain at 7 week

时间窗: Baseline and week 7

Measurement of health perspective with 100 mm visual analogue scale (VAS). We assess the hand pain score change from baseline scores at 7th week. The leftmost value in the 100mm horizontal line used for VAS is scored between 0 mm (no pain) and the rightmost value is rated between 100mm (unbearable pain).

exercise adherance

时间窗: week 7

Qualitative data from smartphone (Time using the app, times of using videos etc)

次要结局

  • Change from baseline of Hand Function(Baseline and week 7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Eda Tonga

Assoc. Prof

Marmara University

研究点 (2)

Loading locations...

相似试验