Table 1 Schedule of enrolment, interventions and assessments
Study timepoints | Study period: A template is adapted from the SPIRIT guidelines[21] | ||||||||
|---|---|---|---|---|---|---|---|---|---|
Enrolment | Allocation | Post-allocation | Close-out | ||||||
-t 1 | 0 | t 1 | t 2 | t 3 | t 4 | t 5 | t 6 | t 7 | |
Participant timeline | Delirium onset | Day 1 | Day 2 | Day 3 | Day 4 | Discharge from hospital | Day 15 | Day 30 | |
Enrolment: | |||||||||
Eligibility screen/Informed consent: | |||||||||
Caregivers | √ | ||||||||
Patients | √ | ||||||||
Allocation of participants | √ | ||||||||
Intervention encounters: | |||||||||
Control group | |||||||||
Intervention group | √ | √ | √ | √ | |||||
Assessments: | |||||||||
Baseline using a sociodemographic questionnaire | √ | ||||||||
1. Primary Objectives: Acceptability and feasibility of: | |||||||||
1.1 –the study design | * | * | * | * | * | * | * | * | * |
1.2 –the intervention | * | * | * | * | * | ||||
1.3 –rSO2 using the INVOS 5100 device from Covidien, Mansfield MA USA | √ | √ | √ | ||||||
2. Secondary Objectives | |||||||||
H1- Delirium Severity assessed using the Delirium Index scale [22] | √ | √ | √ | ||||||
H2- Complications obtained from a keyword search in the medical chart | √ | ||||||||
H3- Length of stay obtained from the medical chart | √ | ||||||||
H4- Recovery assessed using the Sickness Impact Profile scale [23, 24] | √ | ||||||||
H5- Anxiety assessed with the State Trait Anxiety Inventory State [25] | √ | √ | √ | √ | |||||
H6- Self-efficacy assessed with a scale adapted from Bandura [26] | √ | √ | √ | √ | |||||