Video information to support the process of obtaining informed consent: using foetal tissue for brain tumour research

ISRCTN	ISRCTN24829815
DOI	https://doi.org/10.1186/ISRCTN24829815
Protocol serial number	N0192107555
Sponsor	Department of Health
Funder	Queen's Medical Centre University Hospital NHS Trust (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr DA Walker
Scientific

Academic Division of Child Health
School of Human Development
E Floor East Block
University Hospital
Nottingham
NG7 2UH
United Kingdom

Phone	+44 (0)115 924 9924 ext 43324/41727
Email	david.walker@nottingham.ac.uk

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	31/12/2006

Participant type(s)	Patient
Age group	Neonate
Sex	Female
Target sample size at registration	20
Key inclusion criteria	1. Age range of subjects 18 - 40 years 2. Female
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	30/01/2002
Date of final enrolment	31/12/2006

Academic Division of Child Health

Nottingham
NG7 2UH
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Interim results article	interim results	01/12/2003		Yes	No