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
Secondary identifying numbers RBK99XX4
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

Division of General Practice
University of Nottingham
University Hospital
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom

ORCiD logoORCID ID 0000-0003-3603-6542
Phone +44 (0)115 970 9389
Email denise.kendrick@nottingham.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typePrevention
Scientific titleA randomised controlled trial of health visitor safety advice plus low cost safety equipment for families living in deprived areas
Study objectivesTo 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) studiedInjury
InterventionThe 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 typeOther
Primary outcome measurePrimary outcome measure: the proportion of families in which at least one child experiences a medically attended unintentional injury (primary and secondary care).
Secondary outcome measuresNot provided at time of registration
Overall study start date01/11/1999
Completion date30/04/2002

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaAll families with children under 5 in practices with a Townsend score of >0.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/11/1999
Date of final enrolment30/04/2002

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Division of General Practice
Nottingham
NG7 2UH
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive Trent (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot 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.