A randomised controlled trial of health visitor safety advice plus low cost safety equipment for families living in deprived areas
| ISRCTN | ISRCTN73132287 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN73132287 |
| Protocol serial number | RBK99XX4 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Trent (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 06/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Injury, Occupational Diseases, Poisoning
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Denise Kendrick
Scientific
Scientific
Division of General Practice
University of Nottingham
University Hospital
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
 ORCID ID |
0000-0003-3603-6542 |
|---|---|
| Phone | +44 (0)115 970 9389 |
| denise.kendrick@nottingham.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised controlled trial of health visitor safety advice plus low cost safety equipment for families living in deprived areas |
| Study objectives | To assess the effectiveness of health visitor safety advice coupled with access to low cost safety equipment for low income families with children under 5, living in deprived areas. |
| Ethics approval(s) | Ethics approval as of 06/02/2019: Queen's Medical Centre, Nottingham University Hospital NHS Trust Ethics Committee, 13/07/1999, ref. EX039903. Previous ethics approval: Queen's Medical Centre Research Ethics Committee, Nottingham |
| Health condition(s) or problem(s) studied | Injury |
| Intervention | The intervention group will receive a 20 min safety consultation with the health visitor based on the principles used in adult learning, plus opportunistic reinforcement of safety education at future consultations. Low cost equipment available will include stair gates, fireguards, smoke alarms, cupboard locks and window catches. Control group received standard care. |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary outcome measure: the proportion of families in which at least one child experiences a medically attended unintentional injury (primary and secondary care). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/04/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | All families with children under 5 in practices with a Townsend score of >0. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/11/1999 |
| Date of final enrolment | 30/04/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Division of General Practice
Nottingham
NG7 2UH
United Kingdom
NG7 2UH
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/06/2003 | Yes | No | |
| Results article | results | 01/12/2004 | Yes | No | |
| Results article | results | 22/01/2005 | Yes | No | |
| Results article | results | 01/11/2005 | Yes | No | |
| Results article | results | 01/12/2005 | Yes | No | |
| Results article | results | 01/05/2006 | Yes | No |
Editorial Notes
06/02/2019: The ethics approval was updated.
31/01/2019: The following changes were made:
1. The ORCID was added.
2. The ethics was added.
3. Publication references added.
