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Table 6 Measurements with screening and follow-up visit schedule

From: Weight-loss and exercise for communities with arthritis in North Carolina (we-can): design and rationale of a pragmatic, assessor-blinded, randomized controlled trial

Measurements PSV SV1 FU6 FU12 FU18 Explanation
Informed Consent   x     
Eligibility Questionnaire x      To determine eligibility
Medical History xc x x x x For eligibility and to document changes in health
Risk Stratification xc x     Used to screen for cardiovascular risk [54]
Comorbidities Questionnaire   x x x x [55]
Randomization   x     
WOMAC   x x x x Pain is primary outcome [42]
KOOS   x x x x Pain, symptoms, ADL, sport, recreation, knee QOL [56]
ICOAP   x x x x Intermittent and constant osteoarthritis pain, 2 sleep questions [57]
Cost Effectiveness   x x x x  
PASE scale   x x x x Physical Activity Scale for the Elderly [58]
MOCA   x    x Montreal Cognitive Assessment [59, 60]
CES-D   x x x x The Center for Epidemiologic Studies Depression Scale [61]
EuroQol Quality of Life(EQ5D)   x x x x Quality of life measure [62]
Work History Resource   x x x x Visits to clinicians, tests, medications, injections, surgery, alternative therapies
Work Productivity and Activity Impairment Index   x x x x Assesses absenteeism and presenteeism [63]
DHQ II   x x x x NIH Diet History Questionnaire [36, 37]
SF-36   x x x x Health related quality of life [physical, mental] [64]
Self-Efficacy-Adherence   x x x x Belief can exercise over time [65]
Perceived Stress (PSS)   x x x x The degree to which people perceive their lives as stressful [66]
Pain Catastrophizing Scale (PCS)   x x x x Catastrophizing [rumination, magnification, and helplessness] [67, 68]
Healthy Literacy   x x x x Functional health literacy [69]
Walking Efficacy for Duration   x x x x Confidence in walking for different durations [65]
Gait Efficacy   x x x x Confidence in completing gait related tasks [65]
Weight Efficacy Lifestyle Questionnaire (WEL)   x x x x Self-Efficacy for weight management [70]
Positive and Negative Affect Scale (PANAS)   x x x x Positive and Negative Affect [71]
Demographics   x     
Medication form   x x x x Atherosclerosis Risk in Communities form [72]
Satisfaction With Life Scale   x x x x Quality of life [73]
Physical Performance Tests/Knee Exam
Height and weight x x     To determine BMI
Adverse Events   x x x x Also collected as they occur
Knee exam   x     To determine eligibility
Pain Severity    x x x To determine MCID [74]
6 min walk   x x x x Measure of mobility [75]
Expanded Short Physical Performance Battery (SPPB)   x x x x Gait speed, sit to stand, balance tests; predicts disability [76]
Functional Leg Strength   x x x x Sit to stand test, part of SPPB
Blood Pressure   x x x x Overall health measure
GAITRite gait analysis   x x x x Temporospatial gait variables
Stair climb   x x x x Timed Stair ascent and descent [77]
  1. xc brief screen by self-report, PSV Prescreening Visit, SV screening visit, FU follow-up 6, 12, 18 months after screening visit, MCID minimally clinically important difference