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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

Questionnaires

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