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Table 1 Example study schedule for a patient receiving all aspects of the intervention with 17 weeks between randomisation and planned surgery date

From: Osteoarthritis Preoperative Package for care of Orthotics, Rehabilitation, Topical and oral agent Usage and Nutrition to Improve ouTcomes at a Year (OPPORTUNITY); a feasibility study protocol for a randomised controlled trial

Visit

Pre-op

Post-op

ortho-paedic clinic visit

Baseline visit

Phone review

Clinic review

Phone review

Clinic review

Phone review

Clinic review

Phone review

Clinic visit3

Phone review

Clinic review

Phone review

Final review (clinic)

Surgery

follow-up clinic visit

Week

 

0

1

2

3

4

5

6

7

8–12

13

14

15

16

17

 

All participants:

 Consent to researcher contact

X

               

 PIS

X

               

 Inclusion/exclusion criteria

 

X

              

 Informed consent

 

X

              

 Demographic details

 

X

              

 Medical history

 

X

              

 Height

 

X

              

 Weight

 

X

X2

X

 

X

 

X

 

X

 

X

 

X

 

X

 Blood pressure

 

X

           

X

 

X

 Questionnaires1

 

X

           

X

 

X

 Pain score

 

X

X2

X

 

X

 

X

 

X

 

X

 

X

 

X

 Timed get-up-and-go test

 

X

           

X

 

X

 Randomisation

 

X

              

 Adherence review

  

X2

X

X

X

X

X

X

X

X

X

X

X

  

 Interviews4

  

X

 

X

 Satisfaction questionnaire

               

X

Intervention arm only:

 Intervention delivery

 

X

X2

X

X

X

X

X

X

X

X

X

X

X

  

Weight-loss aspect only:

 ESE questionnaire

 

X

           

X

 

X

 BEQ/EDE questionnaires

 

X

       

X 6

   

X 6

 

X 6

 Blood pressure

  

X2

X

 

X

 

X

 

X

 

X

 

X

 

X

 Blood glucose

 

X

X2

X

 

X

 

X

 

X

 

X

 

X

 

X

 Total Diet Replacement phase

  

X

X

X

X

X

X

X

X

      

 FR/WLM phase5

          

X

X

X

X

  
  1. 1Questionnaires include Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), EuroQol five dimensions questionnaire (EQ-5D), OKS, pain self-efficacy scale, arthritis self-efficacy and eating self-efficacy scale (for those participants receiving the weight loss aspect of the intervention)
  2. 2Additional clinic visit for participants with diabetes and/or hypertension only who are receiving the weight loss aspect of the intervention. An additional blood pressure measurement will be collected for participants with hypertension. An additional blood glucose measurement for those participants with type-2 diabetes will be collected. A weight measurement will also be collected at this visit and a clinic review Case Report Form (CRF) completed
  3. 3The Total Diet Replacement (TDR) will be delivered for a minimum of 8 weeks and a maximum of 12 weeks. The final visit of the TDR phase should be a clinic visit to allow collection of weight and blood pressure measurements and delivery fo advice on food reintroduction
  4. 4Interviews will be conducted at an appropriate time before surgery or during the 90-day follow-up period
  5. 5FR Food Reintroduction, WLM Weight Loss Maintenance. Depending on the time available before surgery, some patients may progress to the Weigh Loss Maintenance phase
  6. 6Binge-eating questionnaires should be repeated at the end of TDR, end of FR and at follow-up if a binge-eating disorder was identified at the baseline visit and if participants display issues with eating food while on TDR
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Trials

ISSN: 1745-6215