Assistive Device for Hand Osteoarthritis

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.

Study Overview

• Status: Completed
• Conditions: Hand Osteoarthritis
• Intervention / Treatment: Other: Self care program focusing on the assistive device

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 Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • PE
    • Recife, PE, Brazil, 50670-420
      • Hospital das Clinicas - Universidade Federal de Pernambuco

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; Self care program focusing on the assistive device, For 4 weeks (1 to week lasting 90 minutes).	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.
No Intervention: Control group; receive only a brochure with orientations of joint protection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Occupational Performance	involvement of daily activities by the Canadian Occupational Performance Measure (COPM)	4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of life	Evaluation by WHO-QOL bref	4 weeks
Manual functional	Evoluation by SACRAH	4 weeks
Pain	Evaluation by visual analogue pain scale	4 weeks

Collaborators and Investigators

• Sponsor: Daniela Salgado Amaral
• Investigators: Study Chair: Claudia DL Marques, PhD, Universidade Federal de Pernambuco

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: November 1, 2014
• Primary Completion (Actual): January 1, 2016
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: April 15, 2015
• First Submitted That Met QC Criteria: January 25, 2016
• First Posted (Estimate): January 28, 2016

Study Record Updates

• Last Update Posted (Estimate): January 28, 2016
• Last Update Submitted That Met QC Criteria: January 25, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: hand osteoarthritis; self care program; assistive tecnology
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Osteoarthritis
• Other Study ID Numbers: UFPernambuco2015

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: No individual participant data will be shared