Condition category
Not Applicable
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
22/09/2014
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

Prof Nigel Mathers

ORCID ID

Contact details

Institute of General Practice and Primary Care
University of Sheffield
Community Sciences Centre
Northern General Hospital
Sheffield
S5 7AU
United Kingdom
+44 (0)114 271 5922
n.mathers@sheffield.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0071173444

Study information

Scientific title

Acronym

Study hypothesis

The pilot will be used to address the following question under four key research themes:
Use of the booklets
1. What is the most appropriate way of training the staff to use the booklets?
2. How do staff use the booklets in their decision making?
3. What are staff perspectives on the use of the tool (utility, ease of use, etc)?
4. Can the booklets be used as effectively by different staff groups (health visitors, link workers and support workers)?

Impact on the service user
5. How satisfied are mothers with the encounter with staff with and without the use of the booklets?
6. Identify whether, and how, the needs of women are currently being met.

Impact on staff
7. How satisfied are the staff with their encounter with the mother, with and without the booklet?

Research to inform future trial
8. Does the use of the booklet impact on the different health outcome measures used in the study?
9. What are the most appropriate health outcomes measures for this population?
10. Based on the primary outcome measure, what sample size is required for the main study?
11. How effective are the data collection tools at capturing the information required to determine the study outcomes?

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

Other

Trial type

Other

Patient information sheet

Condition

Communication between health visitors and women from ethnic minority communities

Intervention

We propose to undertake the pilot within three UK regions: Sheffield, Glasgow and Camden.

The unit of randomisation for the purpose of this trial will be the practices that provide health services in areas with high proportions of women from the target population groups. The practices will be randomized using a computer-generated randomisation list. In total each region will be asked to identify eight practices that are willing to participate in the trial.

The eight practices from each region will be randomly allocated into one of four groups:
1. Group 1: Control: Routine treatment* (no use of the booklets)
2. Group 2: Use of booklets with no training*
3. Group 3: Use of booklets with a training pack
4. Group 4: Use of booklets with a training pack and workshop training.

*All participants in groups 1 and 2 will be offered the opportunity for training in the use of the booklets following completion of the trial.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The main outcomes of interest from this phase of the research are:
1. User satisfaction with their interaction (measured by a generic satisfaction tool)
2. HV satisfaction with their interaction with the client (measured using the Agnew Relationship Measure, and qualitatively through the focus groups)
3. Change in health status of the participant
4. Diagnosis of PND during the trial period

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/10/2005

Overall trial end date

30/09/2006

Reason abandoned

Eligibility

Participant inclusion criteria

All mothers who have a baby that is up to one year of age during the recruitment period, with English as a second language will be invited to participate in the trial. However, particular attention will be paid to the selection of participating health visitors to ensure that the areas of greatest racial diversity are included in the trial. On average, each practice will need to recruit around 10 mothers to ensure a total recruitment of 60 women into the control arm and 180 into the intervention arm. To reduce the possibility of selection bias, HVs will be asked to invite all consecutive eligible women to participate in the trial until they have reached the target number per site. The use of the booklets will be based on the clinical judgement of the HVs. All postnatal Arabic, Chinese, Urdu, Bengali, Somali speaking women in the identified practices will be approached.

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

240 women

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/10/2005

Recruitment end date

30/09/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Institute of General Practice and Primary Care
Sheffield
S5 7AU
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

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

Funders

Funder type

Government

Funder name

Sheffield Health and Social Research Consortium (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Publication citations

Additional files

Editorial Notes