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NCT Number: NCT04263974

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

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.

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Key information

Conditions

Rheumatoid Arthritis - Hand Joint Mobility Limitation Neurologic Manifestations Osteoarthritis Hand Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Stiffness of Hand, Not Elsewhere Classified

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine

Seville, 41009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • Rheumatoid nodules.
  • Abnormal serum rheumatoid factor.
  • Pain and dysfunction in the joints of the hands and/or wrists.
  • Possession of a smartphone with internet

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Self reported functional ability assessed using Michigan Hand Questionnaire (MHQ) in patients with hand Rheumatoid Arthritis

    Time frame: 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

  2. Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis

    Time frame: 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

Secondary outcomes

  1. Grip strength assessed using a hydraulic grip dynamometer

    Time frame: 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

  2. Pinch strength assessed using a hydraulic pinch dynamometer

    Time frame: 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

  3. Self reported pain assessed using a Visual Analog Scale of pain

    Time frame: 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)

  4. Self reported stiffness assessed using a Visual Analog Scale of Stiffness

    Time frame: 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)

  5. Self-reported functional ability assessed by QuickDASH Questionnaire

    Time frame: 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

  6. Dexterity assessed using the Nine Hole Peg Test

    Time frame: 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.

  7. Quality of life assessed using the EQ-5D-5L questionnaire

    Time frame: 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

  8. Economic factors relating to cost-utility

    Time frame: 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

Sponsors and collaborators

Lead sponsor

University of Seville

Other

Collaborators

  • Fundación Pública Andaluza Progreso y Salud
  • Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

Registry information

Official study title

Effectiveness of a Mobile Application of Exercise and Education for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis on Self-reported Functional Ability, Dexterity, Pinch and Grip Strength, Pain Intensity and Stiffness

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
Feb 11, 2020
Registry last updated
Jan 11, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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