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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 213
- 试验地点
- 2
- 主要终点
- Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis
时间窗: 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
时间窗: 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
次要结局
- Grip strength assessed using a hydraulic grip dynamometer(Change from Baseline Grip Strength at 3 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)
- Dexterity assessed using the Nine Hole Peg Test(Change from Baseline Nine Hole Peg Test at 3 months)
- Pinch strength assessed using a hydraulic pinch dynamometer(Change from Baseline Pinch strength at 3 months)
- Self-reported functional ability assessed by QuickDASH Questionnaire(Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 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)
- Economic factors relating to cost-utility(Change from Baseline Economic factors relating to cost-utility at 6 months)
- Quality of life assessed using the EQ-5D-5L questionnaire(Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months)
研究者
Alberto Marcos Heredia-Rizo
Assistant Professor
University of Seville