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

NCT04263974 | Completed DMC

• 1 other identifier: PI_RH_2018
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• 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

  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

  Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months

Secondary Outcomes (8)

• Grip strength assessed using a hydraulic grip dynamometer

  Change from Baseline Grip Strength at 3 months

• Pinch strength assessed using a hydraulic pinch dynamometer

  Change from Baseline Pinch strength at 3 months

• Self reported pain assessed using a Visual Analog Scale of pain

  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

  Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months

• Self-reported functional ability assessed by QuickDASH Questionnaire

  Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months

Study Arms (2)

Smartphone Application

EXPERIMENTAL

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

Conventional Treatment

ACTIVE COMPARATOR

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

Interventions

Smartphone Application 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

Smartphone Application

Conventional treatment 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.

Conventional Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Hard tissue enlargement of 2 or more of 10 hand joints.
• Hard tissue enlargement of 2 or more interphalangeal joints.
• Fewer than 3 swollen Metacarpal joints.
• 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.
• 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:
• Morning stiffness in and around joints lasting at least 1 hour.
• Swelling in three or more joints.
• Swelling in hand or wrist joints,
• Symmetrical joint swelling.
• erosions or decalcification on radiographs of hand and/or wrist.

You may not qualify if:

• 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)
• 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.

Sponsors & Collaborators

• University of Seville: lead
• Fundación Pública Andaluza Progreso y Salud: collaborator
• Fundación Pública Andaluza para la gestión de la Investigación en Sevilla: collaborator

Study Sites (1)

Faculty of Medicine

Seville, 41009, Spain

Location

Related Publications (2)

• 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.

  PMID: 35389367 DERIVED

• 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.

  PMID: 32912305 DERIVED

MeSH Terms

Conditions

Pain; Mobility Limitation

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 11, 2020
• Study Start: March 1, 2020
• Primary Completion: December 20, 2020
• Study Completion: February 25, 2021
• Last Updated: January 11, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)