Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0201119628
Study information
Scientific title
Acronym
Study hypothesis
The effectiveness of nurse-led intervention to provide psychological support to relatives and patients in intensive care.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Mental and Behavioural Disorders: Anxiety
Intervention
1. Control group will receive the usual psychological support provided on AICU
2. Intervention group will require additional psychological support tailored to the individual's needs.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/03/2003
Overall trial end date
01/04/2004
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
272 relatives and patients over 12 months and 400 for the duration of the study
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/03/2003
Recruitment end date
01/04/2004
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Anaesthetic & Critical Care
London
SW3 6NP
United Kingdom
Sponsor information
Organisation
Department of Health (UK)
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Royal Brompton and Harefield NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list