Rheumatoid Arthritis - Hand JointNCT04263974
Effectiveness of an Exercise Program and Education Through a Mobile Application for the Management of Patients With Hand Osteoarthritis and Rheumatoid Arthritis
A study testing Smartphone Application and Conventional treatment in people with Rheumatoid Arthritis - Hand Joint and Osteoarthritis Hand, run by University of Seville at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand, Pain
- What is being tested?
- Smartphone Application and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteSpain
- Study dates
- 1 Mar 2020to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand, Pain, Mobility Limitation, Stiffness of Hand, Not Elsewhere Classified
- Being tested
- Smartphone Application, Conventional treatment
- Medical subject headings
- Pain, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone ApplicationOther
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 treatmentOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Smartphone Application | Experimental | 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. Receives: Other: Smartphone Application |
| Conventional Treatment | Active comparator | 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. Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Change from Baseline Michigan Hand Questionnaire (MHQ) at 3 and 6 months
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
Measured: Change from Baseline Australian/Canadian (AUSCAN) Osteoarthritis Hand Index at 3 and 6 months
Secondary outcomes (8)
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
Measured: Change from Baseline Grip Strength at 3 months
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
Measured: Change from Baseline Pinch strength at 3 months
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)
Measured: Change from Baseline Visual Analog Scale of Pain at 1, 3 and 6 months
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)
Measured: Change from Baseline Visual Analog Scale of Stiffness at 3 and 6 months
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
Measured: Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months
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.
Measured: Change from Baseline Nine Hole Peg Test at 3 months
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
Measured: Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months
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
Measured: Change from Baseline Economic factors relating to cost-utility at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start1 Mar 2020
- Primary completion20 Dec 2020
- Study completion25 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid Arthritis - Hand JointStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Seville
- Sponsor type
- University, hospital or other
- Collaborators
- Fundación Pública Andaluza Progreso y Salud, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Responsible party
- Principal investigator, Alberto Marcos Heredia-Rizo, University of Seville
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04263974
- Sponsor's protocol ID
- PI_RH_2018
- Status last verified
- Jan 2022
- First submitted
- 7 Feb 2020
- Last updated
- 11 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35389367Rodriguez-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.
PubMed 32912305
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04263974
- Acronym / sponsor ID
- PI_RH_2018
- Conditions
- Rheumatoid Arthritis - Hand Joint, Osteoarthritis Hand, Pain, Mobility Limitation, Stiffness of Hand, Not Elsewhere Classified
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of SevilleUniversity, hospital or other
- Collaborators
- Fundación Pública Andaluza Progreso y Salud, Fundación Pública Andaluza para la gestión de la Investigación en Sevilla
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 11 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Smartphone Application | Experimental | Other: Smartphone ApplicationA 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 | Active comparator | Other: Conventional treatmentThose 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Hand Osteoarthritis (OA) patients:
- Rheumatoid Arthritis (RA) Hand patients:
Key exclusion criteria (13 listed)
- Hand Osteoarthritis Patients:
- Rheumatoid Arthritis Hand Patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smartphone ApplicationExercises 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 | Other | Smartphone Application |
| Conventional treatmentConventional 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. | Other | Conventional Treatment |
Primary outcome
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
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
8 secondary outcomes
Grip strength assessed using a hydraulic grip dynamometer
Time frame: Change from Baseline Grip Strength at 3 months
Pinch strength assessed using a hydraulic pinch dynamometer
Time frame: Change from Baseline Pinch strength at 3 months
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
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
Self-reported functional ability assessed by QuickDASH Questionnaire
Time frame: Change from Baseline QuickDASH Questionnaire at 1, 3 and 6 months
Dexterity assessed using the Nine Hole Peg Test
Time frame: Change from Baseline Nine Hole Peg Test at 3 months
Quality of life assessed using the EQ-5D-5L questionnaire
Time frame: Change from Baseline EQ-5D-5L Questionnaire at 3 and 6 months
Economic factors relating to cost-utility
Time frame: Change from Baseline Economic factors relating to cost-utility at 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2022.
- Derived from this study: PubMed 35389367Rodriguez 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.
- Derived from this study: PubMed 32912305Rodriguez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone Application and Conventional treatment in people with Rheumatoid Arthritis - Hand Joint and Osteoarthritis Hand, run by University of Seville at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04263974, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2022.