Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis

University of Seville

Status: Completed

Conditions: Rheumatoid Arthritis - Hand Joint; Stiffness of Hand, Not Elsewhere Classified; Osteoarthritis Hand; Mobility Limitation; Pain

Treatments: Other: Smartphone Application; Other: Conventional treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04263974

PI_RH_2018

Details and patient eligibility

About

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.

Enrollment: 213 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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;

     1. Hard tissue enlargement of 2 or more of 10 hand joints.
     2. Hard tissue enlargement of 2 or more interphalangeal joints.
     3. Fewer than 3 swollen Metacarpal joints.
     4. Deformity of 1 or more of 10 hand joints.

   • Pain and dysfunction in the joints of the hands and/or wrists

   • Possession of a smartphone with internet.

2. 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:

     1. Morning stiffness in and around joints lasting at least 1 hour.
     2. Swelling in three or more joints.
     3. Swelling in hand or wrist joints,
     4. Symmetrical joint swelling.
     5. erosions or decalcification on radiographs of hand and/or wrist.
     6. Rheumatoid nodules.
     7. Abnormal serum rheumatoid factor.

   • Pain and dysfunction in the joints of the hands and/or wrists.

   • Possession of a smartphone with internet

Exclusion criteria

1. Hand Osteoarthritis Patients:

   • Age under 18 years
   • People with cognitive impairment
   • Surgery on any upper limb joint or fracture in the upper limb within the previous 6 months
   • People on the waiting list for upper limb surgery.
   • Persons who have received steroid injections into the joints of their hands in the two months prior to recruitment.
   • People with inflammatory rheumatic disease (arthritis, spondylitis or cancer)

2. Rheumatoid Arthritis Hand Patients

   • Age under 18 years
   • People with cognitive impairment
   • Surgery on any upper limb joint or fracture in the upper limb within the previous 6 months
   • People on the waiting list for upper limb surgery.
   • Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

213 participants in 2 patient groups

Smartphone Application

Experimental group

Description:

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.

Treatment:

Other: Smartphone Application

Conventional Treatment

Active Comparator group

Description:

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.

Treatment:

Other: Conventional treatment