Trial Outcomes & Findings for Hands on - a Hand Care Guide in Systemic Sclerosis (NCT NCT02610842)

Last Updated: 2018-10-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

27 participants

Primary outcome timeframe

08 weeks

Results posted on

2018-10-26

Participant Flow

Patients with SSc were invited to take part in this study during their routine appointments at University of Campinas Rheumatology Outpatient Clinic.

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.

Participant milestones

Participant milestones
Measure	Handbook Group 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.
Overall Study STARTED	27
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Reasons for withdrawal
Measure	Handbook Group 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.
Overall Study Lost to Follow-up	5

Baseline Characteristics

5 subjects did not complete the protocol and were not used for analysis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Handbook Group n=27 Participants Patients with systemic scleroderma and hands commitment.
Age, Continuous	48.09 years STANDARD_DEVIATION 11.67 • n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Sex: Female, Male Female	18 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Sex: Female, Male Male	4 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) Asian	0 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) Black or African American	0 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) White	13 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) More than one race	9 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=22 Participants • 5 subjects did not complete the protocol and were not used for analysis
Region of Enrollment Brazil	22 participants n=27 Participants

PRIMARY outcome

Timeframe: 08 weeks

Outcome measures

Outcome measures
Measure	Handbook Group n=22 Participants Systemic Scleroderma subjects
Cochin Hand Functional Scale	19.24 units on a scale Standard Deviation 15.78

PRIMARY outcome

Timeframe: 8 weeks

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

Outcome measures

Outcome measures
Measure	Handbook Group n=22 Participants Systemic Scleroderma subjects
Visual Analogue Pain Scale	3.97 units on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Handbook Group n=22 Participants Systemic Scleroderma subjects
Delta Finger-to-palm	92.86 Centimeters Standard Deviation 34.7

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Handbook Group n=22 Participants Systemic Scleroderma subjects
Scleroderma Health Assessment Questionnaire	0.95 units on a scale Standard Deviation 0.53

Adverse Events

Handbook Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Eduardo de Paiva Magalhaes

Unicamp - University of Campinas

Phone: +55 (19) 35217113

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60