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

Not Applicable

Completed

• Conditions: Rheumatoid Arthritis - Hand Joint; Stiffness of Hand, Not Elsewhere Classified; Mobility Limitation; Osteoarthritis Hand; Pain
• Interventions: Other: Smartphone Application; Other: Conventional treatment

• Registration Number: NCT04263974
• Lead Sponsor: University of Seville

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-07
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-11
• Study Start: 2020-03-01
• Primary Completion: 2020-12-20
• Study Completion: 2021-02-25
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-08
• Last Update Posted: 2022-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smartphone Application	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.
Conventional Treatment	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.

Primary Outcome Measures

Name	Time	Method
Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis	Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months	A self administered measure to assess hand pain, stiffness and functionality in persons with hand osteoarthritis
Self reported functional ability assessed using Michigan Hand Questionnaire (MHQ) in patients with hand Rheumatoid Arthritis	Change from Baseline Michigan Hand Questionnaire (MHQ) at 3 and 6 months	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

Secondary Outcome Measures

Name	Time	Method
Grip strength assessed using a hydraulic grip dynamometer	Change from Baseline Grip Strength at 3 months	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
Self reported stiffness assessed using a Visual Analog Scale of Stiffness	Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months	Amount of perceived stiffness represented on a scale of 0 (no stiffness) to 10 (worst stiffness)
Dexterity assessed using the Nine Hole Peg Test	Change from Baseline Nine Hole Peg Test at 3 months	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.
Pinch strength assessed using a hydraulic pinch dynamometer	Change from Baseline Pinch strength at 3 months	The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer
Self-reported functional ability assessed by QuickDASH Questionnaire	Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months	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
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	Amount of perceived pain represented on a scale of 0 (no pain) to 10 (worst pain)
Economic factors relating to cost-utility	Change from Baseline Economic factors relating to cost-utility at 6 months	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
Quality of life assessed using the EQ-5D-5L questionnaire	Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months	A brief multi-attribute health status measure divided in five dimensions questions with Likert response options and a visual analog scale of Health

Trial Locations

Locations (1)

Faculty of Medicine; 🇪🇸 Seville, Spain