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 | Â | Â | Â | Â | Â | Â | X |