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Table 1 Content of the Baseline and 12-week follow-up questionnaires

From: The effects of arthritis gloves on people with Rheumatoid Arthritis or Inflammatory Arthritis with hand pain: a study protocol for a multi-centre randomised controlled trial (the A-GLOVES trial)

Concept

Measurement method

Details

0-wks

12-wks

Demographic and Condition Information

Date of birth

 

 
 

Gender

 

 
 

Time since RA or IA symptom onset

 

 
 

Time since RA or IA diagnosis

 

 
 

Employment status

 

 
 

Marital status

 

 
 

Living status (alone; or with family/significant others)

 

 
 

Medication regimen (i.e. what drugs do they take for their arthritis);

 

 
 

Whether received a steroid injection/oral steroid in the last 6 weeks

 

 
 

Hand dominance (i.e. whether they consider this to be right, left or both).

 

 

Primary outcome

Hand Pain during activity

0-10 (0 = no pain/10 = severe pain) point numeric rating scale of hand pain in the dominant hand during the day [21]

Secondary outcomes

Hand Pain

0-10 (0 = no pain/10 = severe pain)

a) during a typical day during activities in the last week in the non-dominant hand;

b) when resting- separately for the dominant and non-dominant hands; and

c) at night –separately for the dominant and non-dominant hands.

 

Stiffness

Measured separately for the dominant and non-dominant hands:

a) Patient self-reported duration of early morning stiffness affecting the hands (hours/min)

b) 0-10 point numeric rating scale of hand stiffness (no (0) and severe (10) hand stiffness)

 

Self-reported hand condition

a five point rating scale of very severe/severe/moderate/good/very good.

Hand Function

The Measure of Activity Performance of the Hand (MAPHAND) [22, 23]

a self-reported measure of 18 items of performing daily activities with the hands

 

The Michigan Hand Outcomes Questionnaire (MHQ) [24, 25]

assesses right and left hands separately: physical status of the hand (movement, strength, sensation: 5 items); daily activities performed with the hands/arms (5 right and left; 7 bilateral); impact of their condition on their normal activities (5 items); pain frequency, severity and impact (5 items); perceived appearance of their hands (4 items); satisfaction with hand abilities (6 items)

Disability

The Health Assessment Questionnaire [26]

24 items of daily function

Economic analysis

EQ5D-3 L [27, 28]

5-items Scale (Mobility; Self-care; Usual activities; Pain/Discomfort; Anxiety/Depression

 

Your use of NHS and social services

a) Any planned hospital overnight stays in the last 3 months

b) List of planned admissions

 

Your use of hospital out-patient appointments

a) Any planned hospital outpatient appointments lasting 4 h or less in the last 3 months

b) If yes, department, speciality and number of appointments

 

Your use of day hospital appointments

a) Any day or hospital outpatient lasting more than 4 h but not overnight during the last 3 months

b) If yes, department, speciality and number of appointments

 

Your use of accident and emergency services

a) Any A&E attendance in the last 3 months

b) If yes, the number of visits did not lead to hospital admission

c) Were admitted into a hospital as an in-patient from the A&E

d) If yes, department, reason for admission, where and when admitted

 

Your use of primary and community based health services

a) Use of services such as GP, Practice nurse, Nurse, Counsellor in the last 3 months

b) If yes, number of visits to each

 

Your use of primary and community based health services

a) Use of services such as, occupational therapy, Physio, Care worker, Home help, Social worker, Other in the last 3 months

b) If yes, number of visits to each

Medication

Current medication for RA/IA

  

 

Any steroid injection/oral steroids started in the last 12 weeks

Yes/No

 

 

If yes, the date of the injection/started taking oral steroids

DD/MM/YY

 

Health Status

Your own health state today

Measured by a 0-100 vertical scale (0 = worst imaginable state & 100 = best imaginable health state)

 

Additional outcomes

Any other upper limb occupational therapy or physiotherapy treatment received in the last 12 weeks

Type of treatment received

 

 

Whether purchased or obtained from elsewhere, any other “arthritis” gloves.

Yes/No

 

 

If yes, what type these were

  

 

How their hands are in comparison to 12 weeks ago, i.e. before receiving gloves

(much better/better/no change/worse/much worse)

 

 

Concurrent use of any resting, wrist, finger or thumb splints

  

 

Adherence to glove wear

During the day and at night for right/left hand gloves; average time worn at night/during the day; average number of days per week gloves have been worn

 

 

Whether participants considered gloves provided any benefit

Yes/No

 

 

Whether they will continue to wear the gloves provided

Yes/No

 

 

If they considered the gloves of any benefit, what were these

  

 

Any problems encountered when wearing gloves

Freetext