Hand OsteoarthritisNCT02667145
Assistive Device for Hand Osteoarthritis
A study testing Self care program focusing on the assistive device in people with Hand Osteoarthritis, run by Daniela Salgado Amaral at 1 site in Brazil.
Trial summary
Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Hand Osteoarthritis
- What is being tested?
- Self care program focusing on the assistive device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2014to Jan 2016
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hand OA diagnosis according to the criteria of the American College of Rheumatology (ACR )
- Be properly registered in the rheumatology clinic of Hospital das Clínicas
Who cannot join
- Surgical treatment or infiltration in the hands, in the last 6 months;
- Treatment of occupational therapy and / or physical therapy, or use of any TA feature (assist device or stent) in the last 6 months;
- Diagnosis of another rheumatologic disease or musculoskeletal system that compromise the hands associated.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Hospital das Clínicas - Universidade Federal de Pernambuco
Recife, Pernambuco, 50670-420
About this study
Official title: Self-care Program Evaluation With Focus on Assistive Devices for Individuals With Hand Osteoarthritis
Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis.
Read the detailed description
This program aims to:
- Encourage the use of assistive devices on a daily basis as the main form of joint protection.
- Encourage individual motivation, from the group in attendance, behavior change, developing the capacity of self-management of individuals of their health problems.
Will be held for 4 meetings with an average duration of 90 minutes. Meeting 1: Its proposal address the importance of self-care in the treatment of chronic diseases; knowing the OA of the hands and their main characteristics; recognize the importance of hand function for carrying out activities; understand the meaning of self-care and joint protection; motivation adherence to the program and behavior change.
Meeting 2: Present assistive devices as a protection feature; teach joint protection techniques and energy conservation focusing on the assistive device; deliver and demonstrate the use of assistive devices.
Meeting 3:Encouraging the adhesion of the techniques presented; making workshop for daily activities; verify the difficulties with devices use by the volunteers.
Meeting 4: Strengthening guidance given in previous meetings; make closing with the group to in connection with the program; motivated to continue carrying out the activities at home.
- Conditions
- Hand Osteoarthritis
- Being tested
- Self care program focusing on the assistive device
- Keywords
- hand osteoarthritis, self care program, assistive tecnology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self care program focusing on the assistive deviceOther
self-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Self care program focusing on the assistive device, For 4 weeks (1 to week lasting 90 minutes). Receives: Other: Self care program focusing on the assistive device |
| Control group | No intervention | receive only a brochure with orientations of joint protection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occupational Performance
involvement of daily activities by the Canadian Occupational Performance Measure (COPM)
Measured: 4 weeks
Secondary outcomes (3)
Quality of life
Evaluation by WHO-QOL bref
Measured: 4 weeks
Manual functional
Evoluation by SACRAH
Measured: 4 weeks
Pain
Evaluation by visual analogue pain scale
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2016 (estimated)
- Study startNov 2014
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand OsteoarthritisStudies 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
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daniela Salgado Amaral
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Daniela Salgado Amaral, Universidade Federal de Pernambuco
- Investigators
- Claudia DL Marques, PhD, Study chair, Universidade Federal de Pernambuco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02667145
- Sponsor's protocol ID
- UFPernambuco2015
- Status last verified
- Jan 2016
- First submitted
- 15 Apr 2015
- Last updated
- 28 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: No individual participant data will be shared
Publications
Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
PubMed 29185087
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Self-care Program Evaluation With Focus on Assistive Devices for Individuals With Hand Osteoarthritis
- ClinicalTrials.gov ID
- NCT02667145
- Acronym / sponsor ID
- UFPernambuco2015
- Conditions
- Hand Osteoarthritis
- Keywords
- hand osteoarthritis, self care program, assistive tecnology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Daniela Salgado AmaralUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 28 Jan 2016 (estimated)
- 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.
Randomized clinical trial , blind for evaluators, to assess the effectiveness of a self-care program using assistive technology for treatment of hand osteoarthritis.
Detailed description
This program aims to:
- Encourage the use of assistive devices on a daily basis as the main form of joint protection.
- Encourage individual motivation, from the group in attendance, behavior change, developing the capacity of self-management of individuals of their health problems.
Will be held for 4 meetings with an average duration of 90 minutes. Meeting 1: Its proposal address the importance of self-care in the treatment of chronic diseases; knowing the OA of the hands and their main characteristics; recognize the importance of hand function for carrying out activities; understand the meaning of self-care and joint protection; motivation adherence to the program and behavior change.
Meeting 2: Present assistive devices as a protection feature; teach joint protection techniques and energy conservation focusing on the assistive device; deliver and demonstrate the use of assistive devices.
Meeting 3:Encouraging the adhesion of the techniques presented; making workshop for daily activities; verify the difficulties with devices use by the volunteers.
Meeting 4: Strengthening guidance given in previous meetings; make closing with the group to in connection with the program; motivated to continue carrying out the activities at home.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Self care program focusing on the assistive deviceSelf care program focusing on the assistive device, For 4 weeks (1 to week lasting 90 minutes). |
| Control group | No intervention | –receive only a brochure with orientations of joint protection. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Hand OA diagnosis according to the criteria of the American College of Rheumatology (ACR )
- Be properly registered in the rheumatology clinic of Hospital das Clínicas
Key exclusion criteria (3 listed)
- Surgical treatment or infiltration in the hands, in the last 6 months;
- Treatment of occupational therapy and / or physical therapy, or use of any TA feature (assist device or stent) in the last 6 months;
- Diagnosis of another rheumatologic disease or musculoskeletal system that compromise the hands associated.
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 |
|---|---|---|
| Self care program focusing on the assistive deviceself-heed program focusing on the assistive device will consist of four weekly meetings lasting approximately 90 minutes. it will be stimulated the self-heed through knowledge of pathology and guidelines of protection articulate, and will be supplied, and trained the use of assistive devices to improve the performance of volunteers in their daily activities. Assistive devices are devices, not attached to the body, which help people with limited movements and restrictions on participation in the activities of everyday life. Example: thickening of tableware, tin openers. These volunteers will be evaluated in three stages: 1-initial assessment 2-after completion of the program and 90 days after the initial assessment. The questionnaires that will be used are: EVA; SACRAH; COPM; WHOQOL-Bref. | Other | Intervention |
Primary outcome
Occupational Performance
Time frame: 4 weeks
involvement of daily activities by the Canadian Occupational Performance Measure (COPM)
3 secondary outcomes
Quality of life
Time frame: 4 weeks
Manual functional
Time frame: 4 weeks
Pain
Time frame: 4 weeks
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 28 Jan 2016.
- Derived from this study: PubMed 29185087Amaral DS, Duarte ALBP, Barros SS, Cavalcanti SV, Ranzolin A, Leite VMM, Dantas AT, Oliveira ASCRC, Santos PS, Silva JCA, Marques CDL. Assistive devices: an effective strategy in non-pharmacological treatment for hand osteoarthritis-randomized clinical trial. Rheumatol Int. 2018 Mar;38(3):343-351. doi: 10.1007/s00296-017-3892-1. Epub 2017 Nov 28.
- Individual participant dataSharing planned: No. No individual participant data will be shared
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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.
Claudia DL Marques, PhD study chair
Universidade Federal de Pernambuco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self care program focusing on the assistive device in people with Hand Osteoarthritis, run by Daniela Salgado Amaral at 1 site in Brazil.
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 2 inclusion and 3 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 28 Jan 2016. 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 Brazil. 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?
Occupational Performance (time frame: 4 weeks). 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 NCT02667145, which also lists 1 linked publication.
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 28 Jan 2016.