Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04365842
• Other study ID #: 09.2019.577
• Status: Recruiting
• Phase: N/A
• Start date: November 2, 2019
• Est. completion date: August 30, 2020

Study information

• Verified date: April 2020
• Source: Marmara University
• Contact: Eda Tonga, PhD
• Phone: +905323275451
• Email: eda.tonga[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 30, 2020
• Est. primary completion date: July 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Behavioral:
• Digital exercise group
Hand Rehabilitation Program: Developed hand exercise smartphone app which include: Self-assessment, (b) self-monitoring (c) exercises types/frequency/ diary, (d) patient education, (e) behavioral change and encouragement (f) exercise adherence Sample exercises Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient Strengthening exercises of hand and finger muscles Exercises to increase grip and pinch strength Exercises to increase tendon swing and pull angle

Other:
• General Home Hand Therapy
Hand rehabilitation home program will be given to the through the telephone messages with brochures. Hand and finger movements: 6-8 repetitions, according to the diagnosis of the patient Strengthening exercises of hand and finger muscles Exercises to increase grip and pinch strength Exercises to increase tendon swing and pull angle

Locations

Country	Name	City	State
Turkey	Marmara University	Istanbul

Sponsors (2)

Lead Sponsor	Collaborator
Marmara University	The Scientific and Technological Research Council of Turkey

Country where clinical trial is conducted

Turkey, 

References & Publications (4)

Argent R, Daly A, Caulfield B. Patient Involvement With Home-Based Exercise Programs: Can Connected Health Interventions Influence Adherence? JMIR Mhealth Uhealth. 2018 Mar 1;6(3):e47. doi: 10.2196/mhealth.8518. — View Citation

Azevedo R, Bernardes M, Fonseca J, Lima A. Smartphone application for rheumatoid arthritis self-management: cross-sectional study revealed the usefulness, willingness to use and patients' needs. Rheumatol Int. 2015 Oct;35(10):1675-85. doi: 10.1007/s00296-015-3270-9. Epub 2015 Apr 24. — View Citation

Choi W, Zheng H, Franklin P, Tulu B. mHealth technologies for osteoarthritis self-management and treatment: A systematic review. Health Informatics J. 2019 Sep;25(3):984-1003. doi: 10.1177/1460458217735676. Epub 2017 Nov 1. — View Citation

Srikesavan CS, Williamson E, Eldridge L, Heine P, Adams J, Cranston T, Lamb SE. A Web-Based Training Resource for Therapists to Deliver an Evidence-Based Exercise Program for Rheumatoid Arthritis of the Hand (iSARAH): Design, Development, and Usability Testing. J Med Internet Res. 2017 Dec 13;19(12):e411. doi: 10.2196/jmir.8424. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of Hand pain at 7 week	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).	Baseline and week 7
Primary	exercise adherance	Qualitative data from smartphone (Time using the app, times of using videos etc)	week 7
Secondary	Change from baseline of Hand Function	Measure of Activity Performance in the Hand (MAP-HAND). It consists of 18 questions. Each question scores between 0 and 3 points. It worsens as the total score increases.We assess the hand function score change from baseline. scores at 7th week.	Baseline and week 7