Rheumatoid ArthritisNCT03274570
Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life
An observational study of Rheumatoid Arthritis, run by Assiut University.
Trial summary
The aims of the research are: To predict factors affecting hand dysfunction in patient with rheumatoid arthritis To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2017to 31 Jan 2019
- Phase
- Observational
- 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
Study population: patient attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals during the period from September 2017 until September 2018
Who may be able to join
- Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.
Who cannot join
- Patients with other rheumatic diseases.
- Patients less than 18 years old.
- Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
- Patient with any recent history of hand trauma, or surgery.
- Patient with neurological involvement as , peripheral neuropathy and radiculopathy
Trial locations and contacts
No sites are listed yet.
About this study
The aims of the research are:
- To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
- To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis
Read the detailed description
Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory arthritis, associated with considerable impairments of Quality of life .
Hand is the principle means by which an individual interacts with people and objects in the external environment .Many factors affect hand function in addition to arthritis ,. Many RA patients suffer from an increased loss of muscle mass with a significant impact on these patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA .So assessment of factors causing hand dysfunction can provide us a quick and early insight on the debilitating effects of RA on functioning and disability.Thus Early intervention can then be initiated which will help limit joint damage and thereby improve functional outcomes.
- Conditions
- Rheumatoid Arthritis
- Medical subject headings
- Arthritis, Rheumatoid
What is being measured
The primary outcome is the main question the study is designed to answer.
quality of life
Health assessment questionnaire disability index (HAQ)
Measured: one year
Secondary outcomes (1)
hand function
measured by musculoskeletal ultrasound
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2017
- Study start1 Oct 2017 (estimated)
- Primary completion30 Oct 2018 (estimated)
- Study completion31 Jan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Essraa Mohammed, Assiut University
- Investigators
- Safaa A Mahran, professor, Study director, Assiut UniversityEssam Abda, professor, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03274570
- Sponsor's protocol ID
- Hand function in RA
- Status last verified
- Aug 2017
- First submitted
- 27 Aug 2017
- Last updated
- 7 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Hand Dysfunction in Patient With Rheumatoid Arthritis and Its Correlation With Quality of Life
- ClinicalTrials.gov ID
- NCT03274570
- Acronym / sponsor ID
- Hand function in RA
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2017 (estimated)
- Primary completion
- 30 Oct 2018 (estimated)
- Study completion
- 31 Jan 2019 (estimated)
- First posted
- 7 Sep 2017 (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.
The aims of the research are:
- To predict factors affecting hand dysfunction in patient with rheumatoid arthritis
- To study the effect of hand dysfunction on quality of life in patient with rheumatoid arthritis
Detailed description
Rheumatoid Arthritis (RA) is the most common chronic autoimmune systemic inflammatory arthritis, associated with considerable impairments of Quality of life .
Hand is the principle means by which an individual interacts with people and objects in the external environment .Many factors affect hand function in addition to arthritis ,. Many RA patients suffer from an increased loss of muscle mass with a significant impact on these patients' quality of life , and also Distal sensory, mixed sensorimotor, mononeuritis multiplex and entrapment neuropathy are the most commonly reported types of neuropathy in RA .So assessment of factors causing hand dysfunction can provide us a quick and early insight on the debilitating effects of RA on functioning and disability.Thus Early intervention can then be initiated which will help limit joint damage and thereby improve functional outcomes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patient attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals during the period from September 2017 until September 2018
Key inclusion criteria (1 listed)
- Adult Patients who fulfilled the American College of Rheumatology (ACR) (2010) criteria for RA, attending the Rheumatology and Rehabilitation outpatient clinic and in-patient department, Faculty of Medicine, Assuit University Hospitals.
Key exclusion criteria (5 listed)
- Patients with other rheumatic diseases.
- Patients less than 18 years old.
- Patients with co-morbidities influencing disease activity and hand function (e.g., end- stage liver or renal disease, serious infections, or severe cardiac, respiratory, gastrointestinal disease) .
- Patient with any recent history of hand trauma, or surgery.
- Patient with neurological involvement as , peripheral neuropathy and radiculopathy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
quality of life
Time frame: one year
Health assessment questionnaire disability index (HAQ)
1 secondary outcome
hand function
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2017.
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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.
Safaa A Mahran, professor study director
Assiut University
Essam Abda, professor study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Assiut University.
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 1 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Essraa abd el razek, doctor (01009558495, essraamohammed2016@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Sep 2017.