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Table 1 The schedule of enrolment, interventions, and assessments

From: A pragmatic randomised controlled trial (RCT) and realist evaluation of the interdisciplinary home-bAsed Reablement program (I-HARP) for improving functional independence of community dwelling older people with dementia: an effectiveness-implementation hybrid design

TIMEPOINTb

STUDY PERIOD

Enrolment

Allocation

Post-allocation

Close-out

T1a

0 week

T1b

0 week

T2a for 20 weeks

T2b

at + 20 weeks

T3a

for 52 weeks

T3b

at + 52 weeks

T4

6 months from T3b

ENROLMENT:

 Eligibility screen

X

      

 Informed consent

X

      

 Randomisation & Allocation

 

X

     

INTERVENTIONS:

 I-HARP intervention

  

X

 

–

  

 Control: Care as usual

  

–

 

–

  

ASSESSMENTS:

 Baseline Variables

  Global Deterioration Rating Scale (GDRS)

X

      

  Socio-demographic and basic clinical data

X

      

  Addenbrooke’s Cognitive Examination (ACE-III)

X

  

X

 

X

 

 Outcome variables

  Disability Assessment for Dementia (DAD)

X

  

X

 

X

 

  Short Physical Performance Battery (SPPB)

X

  

X

 

X

 

  Collateral Source version Geriatric Depression Scale (CS-GDS)-15

X

  

X

 

X

 

  Quality of life in Alzheimer’s disease (QOL-AD)

X

  

X

 

X

 

  EuroQol 5 dimensions (EQ-5D-5 L) (client and carer)

X

  

X

 

X

 

  Zarit Burden Interview (ZBI)

X

  

X

 

X

 

  Home Safety Self-Assessment Tool (HSSAT)

X

  

X

 

X

 

 Other Data Variables

  Carer diary monthly

X

 

X

X

X

X

 

  Interviews with participants

   

X

   

  Focus groups with key stakeholders

     

X

 

  Adverse/Serious adverse event assessmenta

  

X

X

X

X

 

  Fidelity check

X

X

X

X

X

X

 

Reporting of study resultsb

      

X

  1. aAdverse events are monitored and reported as they occur, for the duration of the study
  2. bWe expect to take about 6 months to complete data analysis and compile the final results paper for an appropriate journal. A summary of the study results will be made available to the referring clinicians and service providers, and study participants