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Table 1 Assessment schedule for primary, and secondary outcome measures

From: The knitting community-based trial for older women with osteoarthritis of the hands: design and rationale of a randomized controlled trial

Assessment

Admission

Daily

Baseline

3/6/9 weeks mid intervention

12 weeks end of intervention

4 weeks follow-up

Informed consent (pre-admission)

X

     

Diagnosis of HOA based on ACR criteria

X

     

Socio-demographics

X

     

Edinburgh Handedness Inventory

X

     

Self-reported daily morning stiffness intensity (Visual analogue scale: VAS) (primary daily outcome)

X

X

X

X

X

X

Self-reported daily pain intensity (VAS)

(intermediate daily outcome)

X

X

X

X

X

X

Pain intensity (Auscan)

(periodic secondary measurement)

  

X

X

X

X

Morning stiffness severity (Auscan)

(periodic secondary outcome)

  

X

X

X

X

Hand functional status/difficulty in activities of daily living (Auscan) (periodic secondary outcome)

  

X

X

X

X

Disease activity status (periodic secondary outcome)

  

X

X

X

X

Dynamometric strength measurements (Grip and pinch measurements) (periodic secondary outcome)

  

X

X

X

X

The Functional Index for Hand Osteoarthritis (FIHOA) (periodic secondary outcome)

  

X

X

X

X

Hand physical activity level (periodic secondary outcome)

 

X

X

X

X

X

Patient global assessment (periodic secondary outcome)

  

X

X

X

X

Quality of life (EQ-5D) (periodic secondary outcome)

  

X

X

X

X

Self-efficacy (periodic secondary outcome)

  

X

X

X

X

Physical Activity Enjoyment Scale

(PACES) (Group 1 only)

   

X

X

X

Adherence to knitting program

(Daily secondary outcome)

  

X

X

X

X

7-day Physical Activity Recall (PAR) (Daily secondary outcome)

  

X

X

X

X