Contact information
Type
Scientific
Primary contact
Dr DA Walker
ORCID ID
Contact details
Academic Division of Child Health
School of Human Development
E Floor East Block
University Hospital
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 924 9924 ext 43324/41727
david.walker@nottingham.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0192107555
Study information
Scientific title
A randomised controlled trial of the use of video information to support the process of obtaining informed consent: to use foetal tissue for brain tumour research
Acronym
Study hypothesis
To assess whether the use of recorded media (video tape) within the informed consent process is as acceptable, feasible and informative as the conventional face-to-face informed consent processes used in current clinical practice.
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
Screening
Patient information sheet
Condition
Informed consent processes
Intervention
Randomised controlled trial to assess whether the use of recorded media (video tape) within the informed consent process is as acceptable, feasible and informative as the conventional face-to-face informed consent processes used in current clinical practice.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
1. Patient assessment of acceptability
2. Patient anxiety levels
3. Patient level of relevant knowledge
4. Patient degree of satisfaction
5. Clinical feasibility and acceptability of the different methods of obtaining informed consent
Secondary outcome measures
Not provided at time of registration
Overall trial start date
30/01/2002
Overall trial end date
31/12/2006
Reason abandoned
Eligibility
Participant inclusion criteria
1. Age range of subjects 18 - 40 years
2. Female
Participant type
Patient
Age group
Neonate
Gender
Female
Target number of participants
Patients = 20 terminations of pregnancy
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
30/01/2002
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Academic Division of Child Health
Nottingham
NG7 2UH
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Queen's Medical Centre University Hospital 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
Results - basic reporting
Publication summary
2003 interim results in http://www.ncbi.nlm.nih.gov/pubmed/14664877
Publication citations
-
Interim results
Mason V, McEwan A, Walker D, Barrett S, James D, The use of video information in obtaining consent for female sterilisation: a randomised study., BJOG, 2003, 110, 12, 1062-1071.