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

NCT ID: NCT04263974

Last Updated: 2022-01-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-03-01
• Study Completion Date: 2021-02-25

Brief Summary

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Smartphone Application

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.

Group Type: EXPERIMENTAL

Smartphone Application

Intervention Type: OTHER

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 Treatment

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.

Group Type: ACTIVE_COMPARATOR

Conventional treatment

Intervention Type: OTHER

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.

Interventions

Smartphone Application

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

Intervention Type: OTHER

Conventional treatment

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role: collaborator

Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

OTHER

Sponsor Role: collaborator

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Alberto Marcos Heredia-Rizo

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Faculty of Medicine

Seville, , Spain

Countries

Spain

References

Rodriguez Sanchez-Laulhe P, Luque-Romero LG, Barrero-Garcia FJ, Biscarri-Carbonero A, Blanquero J, Suero-Pineda A, Heredia-Rizo AM. An Exercise and Educational and Self-management Program Delivered With a Smartphone App (CareHand) in Adults With Rheumatoid Arthritis of the Hands: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2022 Apr 7;10(4):e35462. doi: 10.2196/35462.

Reference Type: DERIVED

PMID: 35389367 (View on PubMed)

Rodriguez-Sanchez-Laulhe P, Luque-Romero LG, Blanquero J, Suero-Pineda A, Biscarri-Carbonero A, Barrero-Garcia FJ, Heredia-Rizo AM. A mobile app using therapeutic exercise and education for self-management in patients with hand rheumatoid arthritis: a randomized controlled trial protocol. Trials. 2020 Sep 10;21(1):777. doi: 10.1186/s13063-020-04713-4.

Reference Type: DERIVED

PMID: 32912305 (View on PubMed)

Other Identifiers

PI_RH_2018

Identifier Type: -

Identifier Source: org_study_id