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Table 4 Summary of measurements to be taken

From: Better Knee, Better Me™: effectiveness of two scalable health care interventions supporting self-management for knee osteoarthritis – protocol for a randomized controlled trial

Domain

Data collection instrument

Time points

Baseline

6 M

12 M

Descriptive data

 Age, gender, height, body mass index

 

  

 Duration of knee OA symptoms

 

  

 Previous treatments and surgery

 

  

 Problems in other joints

 

  

 Medical history

 

  

 Expectation of treatment outcome

5-point ordinal scale

  

Primary outcome measures

 Average knee pain in past week

11-point NRS

 Physical function in past 48 h

WOMAC physical function subscale

Secondary outcome measures

 Weight

Self-reported

 Physical activity

IPEQ-W questionnaire

 Health-related quality of life

AQoL-8D questionnaire

 Perceived change since baseline

Overall change, 7-point ordinal scale

 

 

Change in pain, 7-point ordinal scale

 

 

Change in function, 7-point ordinal scale

 

 

Change in physical activity, 7-point ordinal scale

 

 Satisfaction with care

7-point ordinal scale

 

 Appointment with orthopaedic surgeon

Yes/No

 Depression, anxiety, and stress

DASS-21

 Surgery performed

Self-reported TKJR and arthroscopy

 

 Willingness to undergo surgery

5-point ordinal scale

Other measures

 Health economic data

Quality adjusted life years

Self-reported medication use

Self-reported use of health services/co-interventions

Cost-effectiveness ratio

 

Work productivity (WHO HPQ Short Form)

 Adherence

Number of consultations with physiotherapista

 

 

Number of consultations with dietitianb

 

 

Duration of consultations with physiotherapista

 

 

Duration of consultations with dietitianb

 

 

Self-rated adherence to strengthening exercisea/ physical activitya/weight managementb, 11-point NRS

 

 

 Perceived usefulness

Times accessed website, 5-point ordinal scale

 

Usefulness of website, 11-point NRS

 

 

Usefulness of physiotherapy consultationsa 11-point NRS

 

 

Usefulness of dietitian consultationsb 11-point NRS

 

 

Usefulness of educational resourcesa 11-point NRS

 

 

Usefulness of Fitbita 11-point NRS

 

 

Usefulness of ketogenic dietb 11-point NRS

 

 

Usefulness of strengthening exercise programa 11-point NRS

 

 

Usefulness of physical activity plana 11-point NRS

 

 

Video software ease of usea 11-point NRS

 

 

 Harms

Adverse events

 

 Determinants

Self-efficacy for symptom control (ASES)

Self-efficacy for eating (WELQ)

Attitudes towards self-management (PAM-13)

Treatment beliefs about arthroplasty (TOA)

Fear of movement (BFMS)

 Long-term surgical rates

Number who have had arthroscopy/arthroplasty

 

24 months and 60 months

 
  1. NRS Numeric rating scale, WOMAC Western Ontario and McMaster Universities Osteoarthritis Index, IPEQ-W Incidental and Planned Exercise Questionnaire, AQoL-8D Assessment of Quality of Life Instrument, DASS Depression, Anxiety, and Stress Scale, TKJR Total knee joint replacement, WHO HPQ World Health Organization Health and Work Performance Questionnaire, ASES Arthritis Self-efficacy Scale, WELQ Weight Efficacy Lifestyle Questionnaire, PAM Patient Activation Measure, TOA Treatment beliefs in knee and hip OA – arthroplasty subscale, BFMS Brief Fear of Movement Scale for osteoarthritis
  2. ameasured in Exercise and Exercise plus weight management groups only
  3. bmeasured in Exercise plus weight management group only