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
How are you feeling? Improving communication between health visitors and women from ethnic minority communities
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
Not available in web format, please use the contact details to request a patient information sheet
Condition
Communication between health visitors and women from ethnic minority communities
Intervention
The trialists 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
University of Sheffield
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
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