Clinical trial NCT04263974: Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Rheumatoid Arthritis - Hand Joint
Osteoarthritis Hand
Pain
Mobility Limitation
Stiffness of Hand, Not Elsewhere Classified
Lead sponsor: University of Seville
Sponsor class: OTHER
Collaborators: name: Fundación Pública Andaluza Progreso y Salud
name: Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
First posted: 2020-02-11
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Self reported functional ability assessed using Michigan Hand Questionnaire (MHQ) in patients with hand Rheumatoid Arthritis
timeFrame: Change from Baseline Michigan Hand Questionnaire (MHQ) at 3 and 6 months
measure: Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis
timeFrame: Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months
Secondary outcomes:
measure: Grip strength assessed using a hydraulic grip dynamometer
timeFrame: Change from Baseline Grip Strength at 3 months
measure: Pinch strength assessed using a hydraulic pinch dynamometer
timeFrame: Change from Baseline Pinch strength at 3 months
measure: Self reported pain assessed using a Visual Analog Scale of pain
timeFrame: Change from Baseline Visual Analog Scale of Pain at 1, 3 and 6 months
measure: Self reported stiffness assessed using a Visual Analog Scale of Stiffness
timeFrame: Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months
measure: Self-reported functional ability assessed by QuickDASH Questionnaire
timeFrame: Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months
measure: Dexterity assessed using the Nine Hole Peg Test
timeFrame: Change from Baseline Nine Hole Peg Test at 3 months
measure: Quality of life assessed using the EQ-5D-5L questionnaire
timeFrame: Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months
measure: Economic factors relating to cost-utility
timeFrame: Change from Baseline Economic factors relating to cost-utility at 6 months
Other outcomes:
Locations:
city: Seville
country: Spain
facility: Faculty of Medicine
Study officials:
References:
citation: 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.
citation: 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.