Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis
Primary Purpose
Rheumatoid Arthritis
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Digital exercise group
General Home Hand Therapy
Sponsored by
About this trial
This is an interventional other trial for Rheumatoid Arthritis focused on measuring mhealth, hand exercise, rheumatoid arthritis
Eligibility Criteria
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
Sites / Locations
- Marmara UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Digital exercise group
Waiting list conrol
Arm Description
After the 6-week digital intervention, 1) qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention. 2) The primary outcomes are hand pain and function and exercise adherence will be evaluated for all participants
A hand rehabilitation home program will be given to the patients in the group through the telephone messages with brochures.
Outcomes
Primary Outcome Measures
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).
exercise adherance
Qualitative data from smartphone (Time using the app, times of using videos etc)
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT04365842
First Posted
April 15, 2020
Last Updated
April 27, 2020
Sponsor
Marmara University
Collaborators
The Scientific and Technological Research Council of Turkey
1. Study Identification
Unique Protocol Identification Number
NCT04365842
Brief Title
Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis
Official Title
Development, Feasibility, and Effectiveness of Smartphone Application for Hand Therapy for Patients With Rheumatoid Arthritis: Mix Method Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2020
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2019 (Actual)
Primary Completion Date
July 30, 2020 (Anticipated)
Study Completion Date
August 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Marmara University
Collaborators
The Scientific and Technological Research Council of Turkey
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis
Keywords
mhealth, hand exercise, rheumatoid arthritis
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Digital exercise group
Arm Type
Experimental
Arm Description
After the 6-week digital intervention, 1) qualitative interviews have done with 6-15 patients from intervention group to assess the feasibility of digital intervention.
2) The primary outcomes are hand pain and function and exercise adherence will be evaluated for all participants
Arm Title
Waiting list conrol
Arm Type
Active Comparator
Arm Description
A hand rehabilitation home program will be given to the patients in the group through the telephone messages with brochures.
Intervention Type
Behavioral
Intervention Name(s)
Digital exercise group
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
General Home Hand Therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
Change from baseline of Hand pain at 7 week
Description
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).
Time Frame
Baseline and week 7
Title
exercise adherance
Description
Qualitative data from smartphone (Time using the app, times of using videos etc)
Time Frame
week 7
Secondary Outcome Measure Information:
Title
Change from baseline of Hand Function
Description
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.
Time Frame
Baseline and week 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eda Tonga, PhD
Phone
+905323275451
Email
eda.tonga@gmail.com
Facility Information:
Facility Name
Marmara University
City
Istanbul
ZIP/Postal Code
34854
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eda Tonga, Assoc. Prof
Phone
+905323275451
Email
eda.tonga@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29496655
Citation
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.
Results Reference
background
PubMed Identifier
29237581
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.
Results Reference
background
PubMed Identifier
25903352
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.
Results Reference
background
PubMed Identifier
29090628
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.
Results Reference
background
Learn more about this trial
Effectiveness of Technology-Supported Hand Strengthening and Stretching Exercises in Patients With Rheumatoid Arthritis
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