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Hands on - a Hand Care Guide in Systemic Sclerosis

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ClinicalTrials.gov Identifier: NCT02610842
Recruitment Status : Completed
First Posted : November 20, 2015
Results First Posted : October 26, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
Eduardo de Paiva Magalhães, University of Campinas, Brazil

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Scleroderma
Intervention Other: Handbook
Enrollment 27
Recruitment Details Patients with SSc were invited to take part in this study during their routine appointments at University of Campinas Rheumatology Outpatient Clinic.
Pre-assignment Details Patients were excluded if enrolled in other rehabilitation program in the previous three months, in the presence of hand disability due other pathologies rather than Systemic Sclerosis, or if they could not perform the exercises proposed as intevention due to medical conditions or advanced hand deformities.
Arm/Group Title Handbook Group
Hide Arm/Group Description

Patients will receive a home based program named "Hands on” - a hand care guide in Systemic Sclerosis" which includes a handbook with instructions about the disease and hand exercises. Patients will be asked to follow the program instructions and carry out the exercises daily during the following 12 weeks.

Handbook: The handbook named "Hands on” - a hand care guide in Systemic Sclerosis" contains instructions about the Systemic Sclerosis and hand exercises.

Period Title: Overall Study
Started 27
Completed 22
Not Completed 5
Reason Not Completed
Lost to Follow-up             5
Arm/Group Title Handbook Group
Hide Arm/Group Description Patients with systemic scleroderma and hands commitment.
Overall Number of Baseline Participants 27
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 22 participants
48.09  (11.67)
[1]
Measure Analysis Population Description: 5 subjects did not complete the protocol and were not used for analysis
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
18
  81.8%
Male
4
  18.2%
[1]
Measure Analysis Population Description: 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB)   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
13
  59.1%
More than one race
9
  40.9%
Unknown or Not Reported
0
   0.0%
[1]
Measure Analysis Population Description: 5 subjects did not complete the protocol and were not used for analysis
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Brazil Number Analyzed 27 participants
22
1.Primary Outcome
Title Cochin Hand Functional Scale
Hide Description

The purpose of this self-report scale is to measure functional ability in the hand.

The questions ask how much difficulty the person has performing 18 tasks without the help of any assistive device. Kitchen tasks include holding a bowl and a plate full of food, pouring liquid, cutting meat, and peeling fruit. The dressing items include buttoning and opening/closing a zipper. The hygiene items include squeezing a tube of toothpaste and holding a toothbrush. Office items include 2 writing tasks, while other items include turning a doorknob, cutting with scissors, and turning a key in a lock. Score range is from 0–90. A higher score indicates greater disability or more difficulty, whereas a lower score indicates less disability or difficulty.

Time Frame 08 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Handbook Group
Hide Arm/Group Description:
Systemic Scleroderma subjects
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
19.24  (15.78)
2.Primary Outcome
Title Visual Analogue Pain Scale
Hide Description Hand pain (pain-VAS) was assessed using a 10 cm horizontal pain scale. Pain severity was rated from 0-10, where 0 = no pain and 10 = very severe pain
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Handbook Group
Hide Arm/Group Description:
Systemic Sclerosis subjects
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
3.97  (4.5)
3.Secondary Outcome
Title Delta Finger-to-palm
Hide Description The standard finger-to-palm (FTP) measurement is obtained using a ruler to measure the distance (in centimeters)between the tip of the pulp on the 3rd finger and the distal palmar crease while the patient attempts to make a full fist (maximal finger flexion at all 3 finger joints: MCP, PIP, and DIP). The delta FTP is finger extension, the distance between the 3rd fingertip and the distal palmar crease while the patient attempts full finger extension, minus the FTP.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Handbook Group
Hide Arm/Group Description:
Systemic sclerosis subjects
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: Centimeters
92.86  (34.7)
4.Secondary Outcome
Title Scleroderma Health Assessment Questionnaire
Hide Description The Health Assessment Questionnaire, is a self-administered 20-questionnaire that assesses functional ability in eight domains. Questions in each domain are scored in a four-point scale, from 0 (“without difficulty”) to 3 (“unable to do”). The maximum score from each domain is added together and divided by the number of categories completed (score ranging from 0 -better to 3 - worse). The Scleroderma Health Assessment Questionnaire (SHAQ) consists of the 20 items from the HAQ and has five additional questions that assess symptoms caused by Systemic Sclerosis (Raynaud Phemonomenon, digital tip ulcers, gastrointestinal and lung symptoms, as well as overall disease symptoms) using visual analogue scales (VAS). Scores on the VAS range from 0 (does not interfere with activities) to 3 (very severe limitations with activities). The overall score is the sum of each of the five VAS sub scores and the scores for the eight HAQ domains divided by 13. The SHAQ index ranges from 0 to 3.
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Handbook Group
Hide Arm/Group Description:
Systemic Sclerosis subjects
Overall Number of Participants Analyzed 22
Mean (Standard Deviation)
Unit of Measure: units on a scale
0.95  (0.53)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Handbook Group
Hide Arm/Group Description Systemic Scleroderma subjects
All-Cause Mortality
Handbook Group
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Handbook Group
Affected / at Risk (%)
Total   0/22 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Handbook Group
Affected / at Risk (%)
Total   0/22 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Eduardo de Paiva Magalhaes
Organization: Unicamp - University of Campinas
Phone: +55 (19) 35217113
Responsible Party: Eduardo de Paiva Magalhães, University of Campinas, Brazil
ClinicalTrials.gov Identifier: NCT02610842     History of Changes
Other Study ID Numbers: UOP01
First Submitted: November 12, 2015
First Posted: November 20, 2015
Results First Submitted: November 17, 2016
Results First Posted: October 26, 2018
Last Update Posted: October 26, 2018