Condition category
Not Applicable
Date applied
30/09/2004
Date assigned
30/09/2004
Last edited
21/01/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes