Skip to main content

Table 3 Study procedures and assessments

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

Months

0

0–2

3

6f

Study Procedures and Assessments: Participants

Visit 1

RANDOMISATION

Intervention period

Visit 2

Visit 3

Baseline

Follow-up

 Initial eligibility screena

X

Intervention:

PRIDE intervention (3 sessions with a PRIDE facilitator) in addition to usual care

Control:

Usual care only

  

 Informed consentb

X

  

 Demographic information

X

  

 Post-consent eligibility screen: Clinical Dementia Rating (CDR) Scalec

X

  

 Lawton IADL Scale

X

X

X

 EuroQoL Quality of Life (EQ-5D-5 L)

X

X

X

 DEMQOL

X

X

X

 Geriatric Depression Scale (GDS)

X

X

X

 Standardised Mini Mental State Exam (SMMSE)

X

X

X

 Control, Autonomy, Self-realisation and Pleasure (CASP-19)

X

X

X

 Impact on Participation and Autonomy (IPAQ-O) – Social Relations Sub-Scale

X

X

X

 Positive Psychology Outcome Measure (PPOM)

X

X

X

 Social Engagement Checklist

X

X

X

 Global Change Measure

 

X

X

 Client Service Receipt Inventory (CSRI)

X

X

X

 Focus groups with facilitators and participants / supporters

 

Xd

 

Study Procedures and Assessments: Supporters

Visit 1

Visit 2

Visit 3f

Baseline

Follow-up

 Informed consent

X

  

 Supporter questionnaire: EuroQoL Quality of Life (EQ-5D-5 L)e

X

X

X

 Global Change Measuree

 

X

X

 Supporter questionnaire: Client Service Receipt Inventory (CSRI)e

X

X

X

  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