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Table 1 The planned timepoints and methods for outcome data collection

From: An individually randomised controlled multi-centre pragmatic trial with embedded economic and process evaluations of early vocational rehabilitation compared with usual care for stroke survivors: study protocol for the RETurn to work After stroKE (RETAKE) trial

Assessment

Type

Method of completion

Timeline

Screening

Baseline

3 months

6 months

12 months

Participant data

 Screening (demographics/assessment of eligibility)

CRF

Researcher

X

    

 Consent

Consent form

Self-completion

X

    

 Eligibility/location of baseline assessment

CRF

Researcher

 

X

   

 Demographics (age/gender/ethnicity/relationship status/home circumstances/employment details/educational level/driving status)

CRF

Researcher

 

X

   

 Oxford Cognitive Screen (OCS)

CRF

Researcher

 

X

   

 Details of stroke

CRF

Researcher

 

X

   

 Relevant co-morbidities/medical issues

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Contact details (e.g. address/telephone numbers/preferred method of contact/GP details/employer details)

CRF

Researcher

 

X

   

 Change of contact details

CRF

Researcher/OT/CTRU

 

Unscheduled (as made aware)

 Work status

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Hospital Anxiety and Depression Scale (HADS)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Nottingham Extended Activities of Daily Living (NEADL)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Community Integration Questionnaire (CIQ)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Health-related quality of life (EuroQol EQ-5D-5L)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Resource use (primary care/secondary care/emergency care/medications/social services/wider societal costs (e.g. productivity costs, out of pocket costs))

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Work self-efficacy (single question from the Work Ability Index)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Confidence after Stroke Measure (CASM)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Safety reporting

Questionnaire booklet/CRF

Researcher/self-completion

  

X

X

X

 Work status (DWP)

Routine data

Data transfer DWP > CTRU

 

Downloads to be agreed with DWP to allow 12-month data collection

 Usual care data

CRF

Researcher/self-completion

 

X

X

X

X

Carer data

 Consent

Consent form

Self-completion

X

    

 Eligibility

CRF

Researcher

 

X

   

 Contact details (address/telephone numbers/preferred method of contact/GP details)

CRF

Researcher

 

X

   

 Carer demographics (age/gender/ethnicity/relationship to participant/employment details)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Modified Caregiver Strain Index (MCSI)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Health-related quality of life (EuroQol EQ-5D-5L)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Resource use (health, social care, and personal costs)

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X

 Questions relating to impact on carer’s work

Questionnaire booklet

Researcher/self-completion

 

X

X

X

X