Assistive Device for Hand Osteoarthritis

Hand Osteoarthritis Clinical Trial

Official title:

Self-care Program Evaluation With Focus on Assistive Devices for Individuals With Hand Osteoarthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02667145
• Other study ID #: UFPernambuco2015
• Status: Completed
• Phase: N/A
• First received: April 15, 2015
• Last updated: January 25, 2016
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: January 2016
• Source: Universidade Federal de Pernambuco
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hand Osteoarthritis
• Osteoarthritis

Intervention

Other:
• Self care program focusing on the assistive device
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.

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas - Universidade Federal de Pernambuco	Recife	PE

Sponsors (1)

Lead Sponsor	Collaborator
Daniela Salgado Amaral

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occupational Performance	involvement of daily activities by the Canadian Occupational Performance Measure (COPM)	4 weeks	No
Secondary	Quality of life	Evaluation by WHO-QOL bref	4 weeks	No
Secondary	Manual functional	Evoluation by SACRAH	4 weeks	No
Secondary	Pain	Evaluation by visual analogue pain scale	4 weeks	No