An interventional study of Smartphone Application and Conventional treatment in Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand and Pain, sponsored by University of Seville. Completed at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-01-11.
Sponsored by University of Seville · Not applicable, Interventional, and Treatment
Strengthening and stretching exercise programs, and recommendations to protect the affected joint have shown to be effective both clinically and economically in conditions such as hand osteoarthritis and hand rheumatoid arthritis. However, their application format is not up to date. In this sense, problems such as the lack of monitoring by the health professional and the lack of patients motivation may cause poor adherence to the treatment protocol, which is one of the main predictors of treatment efficiency. Therefore, an smartphone application has been developed for the rehabilitation of hand osteoarthritis and rheumatoid arthritis to enhance patients adherence and motivation. The smartphone application includes: a) exercise programs and recommendations based on the most up to date scientific evidence adapted to the pathology; and b) enhancers of patient adherence to treatment (patient diaries and behavioral change strategies).The objective is to develop a cost effective digital solution to optimize the health care offered to these pathologies based on up to date scientific evidence in order to improve the functional ability and the quality of life of these patients, and to reduce the number of consultations to primary and specialized care.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 213 is above the median of 90 across 2,377 interventional studies indexed under Arthritis.
Browse Arthritis studies →University of Seville is the lead sponsor of 127 studies on the registry; 37 are open to participants now.
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Hand Osteoarthritis (OA) patients:
Subjects with hand osteoarthritis according to the American College of Rheumatology (ACR) classification criteria for clinical OA; hand pain, aching or stiffness and 3 of the following points;
Rheumatoid Arthritis (RA) Hand patients:
Subjects with hand arthritis according to the American College of Rheumatology (ACR) clinical and immunological criteria for clinical RA. Patients must meet 4 of the following seven criteria:
Exclusion Criteria:
Hand Osteoarthritis Patients:
Rheumatoid Arthritis Hand Patients
A protocol of exercises and general recommendations based on the current scientific evidence will be provided through a smartphone application. A follow-up of the use of the application will be carried out. The treatment protocol will last 6 months, during which a minimum of 4 weekly sessions of exercises will be carried out at home. Each pathology will have an unique program of exercises and recommendations.
Other: Smartphone Application
Those in this group will received the conventional treatment protocol provided within the Andalusian Public Health System. This will consist on the delivery of an exercise program and recommendations using a sheet of paper. Participants will be told to perform the exercises during 6 months, with minimum of 4 weekly sessions of exercise that will be carried out at home.
Other: Conventional treatment
Exercises and recommendations, based on current scientific evidence, and delivered through the app for Smartphone called CareHand. The intervention protocol is based on strengthening and stretching recommendations for rheumatoid arthritis and osteoarthritis in hands, transferred to an application format through explanatory videos together with tools to improve the autonomy, motivation and adherence of the patient
Conventional approach provided by the Andalusian Public Health System in Primary Care settings. This approach consists of routine visits to the general practitioner specialist, and the delivery of an exercise sheet and recommendations. This general mobility and stretching worksheet contains detailed images, as well as a description of how to perform the exercises and the dose to be taken. While most exercises are intended for the wrist and hands, this sheet also includes basic exercises for the elbow joint.
Self reported functional ability assessed using Michigan Hand Questionnaire (MHQ) in patients with hand Rheumatoid Arthritis
An outcome measurement tool specifically for chronic hand conditions providing information on functionality, satisfaction, appearance and perceived pain, with 37 questions divided into 6 subscales
Time frame: Change from Baseline Michigan Hand Questionnaire (MHQ) at 3 and 6 months
Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis
A self administered measure to assess hand pain, stiffness and functionality in persons with hand osteoarthritis
Time frame: Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months
Grip strength assessed using a hydraulic grip dynamometer
The Maximun power of the hand muscles used to firmly grasp an object by wrapping the fingers around it, pressing it against the palm, and using the thumb to apply counter-pressure, using a Hydraulic grip dynamometer
Time frame: Change from Baseline Grip Strength at 3 months
Pinch strength assessed using a hydraulic pinch dynamometer
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer
Time frame: Change from Baseline Pinch strength at 3 months
Self reported pain assessed using a Visual Analog Scale of pain
Amount of perceived pain represented on a scale of 0 (no pain) to 10 (worst pain)
Time frame: Change from Baseline Visual Analog Scale of Pain at 1, 3 and 6 months
Self reported stiffness assessed using a Visual Analog Scale of Stiffness
Amount of perceived stiffness represented on a scale of 0 (no stiffness) to 10 (worst stiffness)
Time frame: Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months
Self-reported functional ability assessed by QuickDASH Questionnaire
Short form of the Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire. A self administered outcome tool designed to measure physical function and symptoms in persons with musculoskeletal disorders of the upper limb
Time frame: Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months
Dexterity assessed using the Nine Hole Peg Test
Plastic instrument woth a shallow round dish to contain pegs and nine holes on the opposite side. Consist of measuring the time spent to place and remove all the pegs from the holes.
Time frame: Change from Baseline Nine Hole Peg Test at 3 months
Quality of life assessed using the EQ-5D-5L questionnaire
A brief multi-attribute health status measure divided in five dimensions questions with Likert response options and a visual analog scale of Health
Time frame: Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months
Economic factors relating to cost-utility
Absence due to illness, absence from unpaid work, use of health resources (number of consultations to primary care, specialist doctor, physical therapy, occupational therapy, emergency department), pharmacological use for the pathology, medical or technical equipment purchased for the pathology
Time frame: Change from Baseline Economic factors relating to cost-utility at 6 months
Plan to share: No
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University of Seville