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

Primary Purpose

Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand, Pain

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Smartphone Application
Conventional treatment
Sponsored by
University of Seville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Rheumatoid Arthritis - Hand Joint

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Smartphone Application

Conventional Treatment

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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

Full Information

First Posted
February 7, 2020
Last Updated
January 8, 2022
Sponsor
University of Seville
Collaborators
Fundación Pública Andaluza Progreso y Salud, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
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1. Study Identification

Unique Protocol Identification Number
NCT04263974
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
February 25, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Seville
Collaborators
Fundación Pública Andaluza Progreso y Salud, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand, Pain, Mobility Limitation, Stiffness of Hand, Not Elsewhere Classified

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
213 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Smartphone Application
Arm Type
Experimental
Arm Description
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.
Arm Title
Conventional Treatment
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Smartphone Application
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
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 Outcome Measure Information:
Title
Self reported functional ability assessed using Michigan Hand Questionnaire (MHQ) in patients with hand Rheumatoid Arthritis
Description
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
Time Frame
Change from Baseline Michigan Hand Questionnaire (MHQ) at 3 and 6 months
Title
Self reported functional ability assessed by Australian/Canadian (AUSCAN) Osteoarthritis Hand Index in patients with Hand Osteoarthritis
Description
A self administered measure to assess hand pain, stiffness and functionality in persons with hand osteoarthritis
Time Frame
Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months
Secondary Outcome Measure Information:
Title
Grip strength assessed using a hydraulic grip dynamometer
Description
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
Time Frame
Change from Baseline Grip Strength at 3 months
Title
Pinch strength assessed using a hydraulic pinch dynamometer
Description
The maximun power of the pinch muscles, pressing the tip thumb against the tip index finger, using an Hydraulic pinch dynamometer
Time Frame
Change from Baseline Pinch strength at 3 months
Title
Self reported pain assessed using a Visual Analog Scale of pain
Description
Amount of perceived pain represented on a scale of 0 (no pain) to 10 (worst pain)
Time Frame
Change from Baseline Visual Analog Scale of Pain at 1, 3 and 6 months
Title
Self reported stiffness assessed using a Visual Analog Scale of Stiffness
Description
Amount of perceived stiffness represented on a scale of 0 (no stiffness) to 10 (worst stiffness)
Time Frame
Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months
Title
Self-reported functional ability assessed by QuickDASH Questionnaire
Description
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
Time Frame
Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months
Title
Dexterity assessed using the Nine Hole Peg Test
Description
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.
Time Frame
Change from Baseline Nine Hole Peg Test at 3 months
Title
Quality of life assessed using the EQ-5D-5L questionnaire
Description
A brief multi-attribute health status measure divided in five dimensions questions with Likert response options and a visual analog scale of Health
Time Frame
Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months
Title
Economic factors relating to cost-utility
Description
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
Time Frame
Change from Baseline Economic factors relating to cost-utility at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Faculty of Medicine
City
Seville
ZIP/Postal Code
41009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35389367
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.
Results Reference
derived
PubMed Identifier
32912305
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.
Results Reference
derived

Learn more about this trial

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

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