How are you feeling? Improving communication between health visitors and women from ethnic minority communities

ISRCTN	ISRCTN34732877
DOI	https://doi.org/10.1186/ISRCTN34732877
Protocol serial number	N0071173444
Sponsor	Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Funders	Sheffield Health and Social Research Consortium (UK), NHS R&D Support Funding (UK)

Submission date: 29/09/2006
Registration date: 29/09/2006
Last edited: 12/05/2017

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

Prof Nigel Mathers
Scientific

Institute of General Practice and Primary Care
University of Sheffield
Community Sciences Centre
Northern General Hospital
Sheffield
S5 7AU
United Kingdom

Phone	+44 (0)114 271 5922
Email	n.mathers@sheffield.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	How are you feeling? Improving communication between health visitors and women from ethnic minority communities
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	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
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/09/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	240
Key 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.
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/2005
Date of final enrolment	30/09/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

University of Sheffield

Sheffield
S5 7AU
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?
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

12/05/2017: No publications found, verifying study status with principal investigator.