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 |
| Secondary identifying numbers | N0192107555 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 21/01/2009
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
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
Contact information
Dr DA Walker
Scientific
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 |
|---|---|
| david.walker@nottingham.ac.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Screening |
| 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 | 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 study start date | 30/01/2002 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Neonate |
| Sex | Female |
| Target number of participants | Patients = 20 terminations of pregnancy |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Academic Division of Child Health
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
Queen's Medical Centre University Hospital NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Interim results article | interim results | 01/12/2003 | Yes | No |
