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Table 3 Study procedures and assessments

From: Promoting Independence in Dementia (PRIDE): protocol for a feasibility randomised controlled trial

Months00–236f
Study Procedures and Assessments: ParticipantsVisit 1RANDOMISATIONIntervention periodVisit 2Visit 3
BaselineFollow-up
 Initial eligibility screenaXIntervention:
PRIDE intervention (3 sessions with a PRIDE facilitator) in addition to usual care
Control:
Usual care only
  
 Informed consentbX  
 Demographic informationX  
 Post-consent eligibility screen: Clinical Dementia Rating (CDR) ScalecX  
 Lawton IADL ScaleXXX
 EuroQoL Quality of Life (EQ-5D-5 L)XXX
 DEMQOLXXX
 Geriatric Depression Scale (GDS)XXX
 Standardised Mini Mental State Exam (SMMSE)XXX
 Control, Autonomy, Self-realisation and Pleasure (CASP-19)XXX
 Impact on Participation and Autonomy (IPAQ-O) – Social Relations Sub-ScaleXXX
 Positive Psychology Outcome Measure (PPOM)XXX
 Social Engagement ChecklistXXX
 Global Change Measure XX
 Client Service Receipt Inventory (CSRI)XXX
 Focus groups with facilitators and participants / supporters Xd 
Study Procedures and Assessments: SupportersVisit 1Visit 2Visit 3f
BaselineFollow-up
 Informed consentX  
 Supporter questionnaire: EuroQoL Quality of Life (EQ-5D-5 L)eXXX
 Global Change Measuree XX
 Supporter questionnaire: Client Service Receipt Inventory (CSRI)eXXX
  1. aParticipants not included in the trial will be recorded on the screening log, with reasons for non-inclusion documented
  2. bAll participants providing consent will be enrolled on the trial database, with demographic details and screening assessments recorded
  3. cParticipants who are identified as ineligible for randomisation during the post-consent eligibility screen will be defined as screen failures and will not proceed to randomisation
  4. dSeparate focus groups will be completed with a facilitator and a subset of participants and supporters
  5. eSupporter questionnaires will be passed to supporters during participant visits (if present) for completion during the visit or will be posted with a prepaid envelope for return to the Coordinating Centre
  6. fParticipants randomised after 30th June 2019 will not have a 6-month follow-up visit, and their last visit will be at visit 2