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 | ✓ | ✓ |
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 | 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 | ✓ |