Clear Conversations: Evaluating a Verbal Health Literacy Intervention in Derbyshire
Conditions: COPD, Weight Loss
Sponsor: University of Sheffield

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Clear Conversations: 
 Evaluating a Verbal Health Literacy intervention in Derbyshire 
1. Background 
1.1 Health Literacy 
Health Literacy is important so that everyone has the ability to access and receive 
high quality healthcare (WHO 2014). Health literacy has been defined as a person’s 
ability to understand and use information to make decisions about their health so 
they can ‘be active partners in their care’ (NHS England, 2024). People with low 
Health Literacy struggle to read and understand health information, communicate 
with health professionals, know how to act on the information they receive, and know 
what health services to use and when to use them (Osborne et al., 2013). 
1.2 Health literacy and health inequalities 
There is a link between socioeconomic deprivation and low Health Literacy. That is, 
those with lower Health Literacy are more likely to be from socially deprived areas 
and have no educational qualifications (Roberts, 2015). 
Low Health Literacy is associated with: 
- Unhealthy lifestyles and poorer general health 
- Low use of preventative services e.g. vaccinations and screening 
- Increased attendance at A&E and hospital admissions 
- Decreased life expectancy 
 (NHS 2023. NIHR, 2022, Roberts, 2015). 
If Health Literacy is improved this can positively affect treatment adherence, and 
lead to reduced numbers of call backs, cancelled appointments and improved 
satisfaction and outcomes (Roberts, 2015). It has been suggested that interventions 
to improve Health Literacy will best be targeted at those with lower levels of 

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education, those living in the most deprived areas, and those with a limiting health 
condition or disability (Roberts, 2015). 
1.3 The context of this study 
1.3.1 Joined Up Care Derbyshire 
Across Derby and Derbyshire three out of nine areas and six out of ten people are 
estimated to be below the UK average for Health Literacy and numeracy (JUCD, 
2024).  Joined Up Care Derbyshire (JUCD) is one of 42 Integrated Care Systems in 
England. It brings together NHS, local authorities, and the voluntary sector to deliver 
better care to whole communities, both adults and children, in Derbyshire 
(https://joinedupcarederbyshire.co.uk/).  It aims to improve Derbyshire’s population 
life expectancy and healthy life expectancy levels, compared to other parts of the 
country, and reduce health inequalities. 
JUCD has a Stay Well Initiative which includes Quality Conversations, 
Personalisation and Health Literacy. JUCD offers free Quality Conversations training 
to all staff. They also provide information and training resources to staff via their 
website on Personalised Care and Health Literacy. JUCD appointed a Health 
Literacy Officer in 2022. This is a role that it is not commonly seen in Integrated Care 
Systems in the UK. 
1.3.2 Quality Conversations 
Quality Conversations is an evidenced based communications skills programme for 
staff, developed by the Derbyshire Psychological Insights team and Public Health 
Derbyshire, to support the implementation of Making Every Contact Count in 
Derbyshire (Pennell, 2023). It is informed by Michie et al’s (2011) COM-B behaviour 
change model (Mitchie et al., 2011) and is focused on addressing health inequalities 
through ‘compassionate and curious conversations’ (Pennell, 2023). The training 
sessions for staff are delivered by professional coaches and ‘supplemented with a 
suite of localised support, web-based resources, an ambassador network and team-
based sessions to embed the approach and ensure sustainably of learning’ (Pennell, 
2023). 
 

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1.3.3 The Health Literacy Officer role 
The Health Literacy Officer role aims to implement Health Literacy initiatives 
throughout the JUCD system. The officer works with organisations and teams within 
JUCD to support them to take evidence-based steps to provide more Health Literacy 
friendly services. The initial focus of the role has been on written communication. 
The Health Literacy Officer has supported teams to reduce the average reading age 
of their services’ information materials from 18 years of age to 9 across 19 services. 
These changes have received positive feedback from both staff and patients. Now 
the focus is turning to how to embed Verbal Health Literacy techniques into services.  
1.3.4 Verbal Health Literacy interventions - The evidence base 
Improving health professionals’ health literate communication skills is important and 
has the potential to positively impact on person centred prevention activities and 
healthcare, by reducing Health Literacy demands (Connell et al., 2023; Kaper et al., 
2019; Murugesu et al., 2022). Evidence suggests that effective health conversations 
can potentially increase adherence to treatment, patient safety, quality of life and 
health outcomes (Kaper et al., 2019, Connell et al., 2023). 
NHS England and Scotland both advocate the use of good communication, both 
spoken and written, to help address Health Literacy issues (Public Health England, 
2023; NHS Scotland, 2023). In their Health Literacy toolkits and guides they 
recommend the use of: 
• Simple language (NHS Scotland, 2023).  
• Teach-back techniques (Health Education England, NHS England and Public 
Health England, 2023; NHS Scotland, 2023). A method of making sure 
patients understand the health information they receive (Yen and Leasure 
2019), 
• Chunk and check techniques (Health Education England, NHS England and 
Public Health England, 2023; NHS Scotland, 2023). Where information is 
broken down into smaller chunks rather than giving it all at once. Then 

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checking it is understood before moving onto the next ‘chunk’ (NHS Scotland 
2023). 
• Pictures and visual aids (NHS Scotland, 2023). 
A recent study in the USA explored the patient-surgeon encounter using audio-
recordings and a post encounter survey (Rainey et al., 2022). They found that 
improving communication by slowing speech, using more understandable words, 
and intentionally allowing more time for patients to speak and ask questions were 
immediately actionable ways to improve patient understanding (Rainey et al., 2022). 
A number of studies and literature reviews have explored the use of Verbal Health 
Literacy techniques (Kaper et al., 2019; Murugesu et al., 2022; Talevski et al., 2020; 
Yen & Leasure, 2019). However, there are few UK studies exploring this issue. 
Teach-back specifically has been shown to be effective in improving learning related 
outcomes. These outcomes include knowledge recall and retention and health 
related outcomes such as hospital re-admissions and quality of life (Talevski et 
al.,2020). The Teach-back method was recommended by 99% of those using it 
(Murugesu et al., 2022) and was considered to be quick and cost effective (Talevski 
et al., 2020). However, there were inconsistent results related to Teach-back, with 
regards to knowledge retention, and implementation into routine practice was rarely 
considered (Talevski et al., 2020). A training session on Teach-back alone was not 
considered to be adequate for translation into practice to occur or be sustained 
(Talevski et al., 2020; Yen & Leasure, 2019). This indicates the need for additional 
implementation support. In addition, there was a lack of studies using 
comprehensive health literacy outcome measures (Larsen et al., 2022) or patient 
centred outcomes (Walters et al., 2020). 
One UK qualitative study undertaken in Staffordshire focused on community 
pharmacy (Cork & White, 2022). Pharmacists received a one-off training session on 
Teach-back, chunk and check and the use of simple language and visual aids. They 
were given two months to use it in practice before giving their perceptions of its 
usefulness in a semi-structured interview. Key findings included: 

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• Health professionals would have preferred more time to practice the 
techniques with patients. 
• They found chunk and check harder to use than Teach-back and felt it was 
better for longer rather than short consultations. 
• Visual aids were useful. 
• It was easy to slip back into jargon and habitual use of more complicated 
language.  
(Cork & White, 2022). 
This highlights the need to continue to evaluate Health Literacy interventions, 
particularly those aimed at improving Verbal Health Literacy. It also highlights the 
need to explore additional implementation support, and measurement of outcomes 
and experiences over a longer time period. 
1.3.5 The intervention to be evaluated 
The intervention is a Verbal Health Literacy techniques training package for staff. Its 
purpose is to enable clearer health conversations. It has been developed using 
insights gained from the well-established Quality Conversation programme currently 
available to all healthcare and public health staff in Derbyshire. The Verbal Health 
Literacy training is a two hour interactive and experiential session. The main focus is 
on how staff can learn, practice and implement three key Verbal Health Literacy 
techniques: ‘simple language’, ‘Teach-back’ and ‘chunk and check’. This is 
complemented with Health Literacy Officer support for implementation of the 
techniques into practice. The support is tailored to the individual service staff’s 
needs. 
1.3.6 The services where the intervention will be used 
The intervention will be used in two very different services. 
1. Live Life Better Derbyshire tier 2 weight management services (Public Health, 
Derbyshire County Council). The aim of the programme is to help people lose 
weight. The service provides online and face to face group education and 
advice programmes that run for one session a week over a rolling 12 week 
period. The programmes have an accompanying website and resources. The 

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programme is available for all people in Derbyshire. Eight Public Health 
Improvement Advisors (HIA’s) offer advice to groups of up to 25 people who 
need to lose weight. 33 programmes run across Derbyshire, 19 online and 14 
face to face. Attenders are followed up at 12, 26 and 52 weeks and a weight 
maintenance programme is available.  
 
2. Derbyshire Community Health Service Pulmonary Rehabilitation programme 
provided within the NHS. The aim of the programme is to improve people’s 
exercise tolerance and respiratory health.  This service provides a six week 
rolling face to face programme that runs across 6 venues in Derbyshire. 15 
members of staff, a mixture of physiotherapists, healthcare assistants and 
specialist nurses, offer supervised exercise and education and advice to 
people who are limited by their respiratory condition in Derbyshire.  The 
physiotherapists and specialist nurses lead the sessions and have most 
contact with patients. Up to 12 people attend two sessions a week over the six 
week period which are a combination of exercise and education.  
1.3.7 The proposed Theory of Change  
For the Live Life Better Derbyshire service, the training will help staff to communicate 
in simpler language and check service users’ understanding of actions they need to 
take. This will help service users to understand what they need to do to lose weight, 
be activated to self-manage their weight, take actions to lose weight, and adhere to 
the 12 week programme. This will help them to lose weight and maintain weight loss.   
For the Pulmonary Rehabilitation service, the training will help staff communicate in 
simpler language and check service users’ understanding of the actions they need to 
undertake. This is so service users will understand what they need to do to improve 
their exercise tolerance and respiratory health, be more likely to take actions, and 
thus improve their overall health. It is hoped the intervention will also help activate 
people to continue to manage their own physical and respiratory health beyond the 
programme and know what to do should they suffer an acute exacerbation. 
 
 

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2. Research question and aims & objectives 
2.1. 
Research question 
Can a Verbal Health Literacy training intervention for health workers improve health 
outcomes and reduce health inequalities for people using their services? 
2.2. 
Aim 
To investigate whether a Verbal Health Literacy training session for staff, with 
accompanying tailored support from a Health Literacy Officer to help implement the 
techniques into practice, can improve health outcomes for patients. 
2.3. 
Objectives 
a) To understand staff perceptions of the acceptability and feasibility of the 
Verbal Health Literacy training session, and the support to use the techniques 
in practice from the Health Literacy Officer. 
b) To understand staff knowledge of the Verbal Health Literacy techniques and 
their confidence and skills to use them. 
c) To understand how the Verbal Health Literacy techniques taught in the 
training session are being actioned in practice. 
d) To determine whether subjective Health Literacy and activation skills, such as 
the ability to self-manage, engage with healthcare services and understand 
what actions to take, are improved for service users after attending 
programmes delivered by Verbal Health Literacy trained members of staff. 
e) To measure the impact of the Verbal Health Literacy training on health and 
wellbeing outcomes. 
f) To describe the Index of Multiple Deprivation quintile of attendees at 
programmes and compare with the Derbyshire population in order to assess 
impact on health inequalities.  
 
 
 
 
 

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3.Plan of investigation 
3.1 Design 
The objectives will be achieved through a mixed methods evaluation. This will 
consist of a process evaluation to assess acceptability, feasibility and use of the 
learnt techniques in practice (Moore et al., 2015), and a concurrent pre-test post-test 
measurement of outcomes, or controlled pre-test post-test measurement of 
outcomes where possible (Aggarwal & Ranganathan, 2019; NICE, 2012).  
3.2 Timing of intervention 
For both programmes staff will receive Verbal Health Literacy training and 
implementation support from the Health Literacy Officer. Outcomes will be measured 
for service users joining a programme run by trained staff. Where appropriate and for 
comparison, outcomes will be measured for service users joining a programme run 
by non-trained staff during the same period. 
Half of the staff from the weight management programme (4/8) will receive the 
training to allow for controlled before and after comparison of outcomes. One 
member of staff takes a group of service users through their weight management 
sessions so it will be possible to identify service users linked to trained and untrained 
staff. This is not possible for the pulmonary rehabilitation service where different staff 
work with different service users throughout the programme. All six physiotherapists 
and two specialist nurses from the pulmonary rehabilitation service will receive the 
training. The focus is on physiotherapists and specialist nurses because they spend 
most time with service users. 
3.3 Staff perceptions of the acceptability and feasibility of the training and 
support, and their knowledge, confidence and skills to use the techniques 
taught 
3.3.1 Pre and post intervention questionnaires 
The Health Literacy Officer collects pre and post training questionnaire data as part 
of their practice. This data will be made available to the research team with consent 
from individual staff undergoing the training. Questionnaire data will be collected, 

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with consent, from staff from the two participating services who receive the Verbal 
Health Literacy training. The Health Literacy Officer will also be training staff from 
other services in Derbyshire Community Health Services and the Local Authority 
during this time. She will be collecting the same questionnaire data from them. 
Therefore, we will ask these additional staff (approximately 60), who receive the 
Verbal Health Literacy training during the period of the study, to consent to their 
questionnaire data to be used in the study also. Staff will be asked to complete a 
short questionnaire at three time points. 
1. Baseline data will be collected from staff, via a short questionnaire, prior to 
their attendance at the training session. The data collected at this stage will 
include demographic data and ascertain their current knowledge of Verbal 
Health Literacy techniques and whether they have had Health Literacy 
training in the past 
2. Staff will complete a short questionnaire immediately after they have attended 
the Verbal Health Literacy training. This will include questions about how 
useful they found the training and their confidence to use the techniques 
taught. 
3. Staff will complete a final short questionnaire 8 weeks after attending the 
Verbal Health Literacy training to assess their perceptions of whether they are 
using the techniques they learnt in their routine care provision, the facilitators 
and barriers faced and any support they may require helping them use the 
techniques in their practice. 
The questionnaires will be distributed online. This will be via the Derbyshire 
Community Health Services NHS Foundation Trust Microsoft forms web-based 
package. The forms will be distributed via the Health Literacy Officer’s NHS 
Microsoft 360 office account. The Health Literacy Officer will share the anonymised, 
consented data with the lead researcher via email in a password protected 
spreadsheet. 
 
 

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3.3.2 Focus group interviews 
Focus groups will be used to gain deeper and richer insights into participants’ 
experiences and views of the training session itself and the use of the techniques in 
practice (Kitzinger, 1995).  They will allow the staff from the two participating 
programmes to discuss and debate each other’s experiences and views (Kitzinger, 
1995). They will focus on wider contextual factors such as why staff receiving and 
then delivering the intervention may or may not engage with it (Moore et al., 2015). 
Focus groups will supplement the questionnaires by using open rather than closed 
questions and encouraging more detailed responses. A topic guide will be used to 
facilitate the group discussion, but the researcher will be guided by the group’s 
responses and interactions (Kitzinger, 1995) and will probe and dig deeper to 
understand issues of interest as appropriate (Bryman 2008). 
All staff from the two participating services who receive the training will be invited to 
take part in the focus groups. That is four out of eight Health Intervention Workers 
from the weight management programme and six physiotherapists and two specialist 
nurses from the pulmonary rehabilitation programme. The focus groups will take 
place separately for each service involved. That is there will be one focus group for 
the weight management service staff and one focus group for the pulmonary 
rehabilitation staff. This will allow the two groups to discuss together the issues that 
are important to them specific to their area of practice. The focus groups will take 
place during timetabled team meeting time, so it has minimum impact on the service 
and staff time.   
The focus groups will be carried out four – six months after attending the Verbal 
Health Literacy training. They will be carried out face to face or via video call 
depending on the services preference. Face to face will be recorded using an 
encrypted audio recorder and the audio files transcribed verbatim.  Video call 
interviews will take place via Goggle Meet using the researcher’s University of 
Sheffield Google account. The video calls will be recorded and transcribed live using 
the recording and transcribe functions in Google Meet. The video recording and 
transcripts will be downloaded from the researcher’s University of Sheffield Google 

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drive immediately after the session and checked and saved on the University of 
Sheffield secure computer drive. The original recordings will be deleted from the 
Google drive. All the interview transcripts will be (pseudo)anonymised prior to being 
analysed. 
3.4. Assessment of change in how staff use Verbal Health Literacy 
techniques in practice 
To assess if there is a change in the frequency with which staff use the techniques 
they have learnt in practice, the lead researcher will observe or record programme 
sessions before and 12-16 weeks after staff have been trained. The lead researcher 
will observe the extent to which the Health Literacy techniques ‘simple language’, 
‘teach-back’ and ‘chunk and check’ are used. The researcher will attend in person or 
ask the staff member to record programme sessions on an encrypted recorder. The 
researcher will use a checklist to describe how often each of the three 
communication techniques are used:  never, sometimes, most of the time, all of the 
time. All staff from the two services, who will be receiving the training, will be 
approached for permission to assess two of their sessions (4 staff in the weight loss 
service and 8 staff in the pulmonary rehabilitation service). If all agree the researcher 
will observe 24 sessions in total. That is, twelve before they receive the training and 
twelve after. 
Consent will be gained from all staff prior to collecting their data. The focus of this 
part of the project is on staff behaviour. Service users will be involved incidentally. 
Even so, verbal consent will also be gained from service users prior to the 
researcher observing programme sessions.  
3.5. Assessment of individual service user health and wellbeing outcomes 
The two services collect a range of data about service user outcomes. For the weight 
management programme service users complete routine service assessments at 
baseline12 and 26 weeks. For the pulmonary rehabilitation programme assessments 
are carried out at baseline and on completion of the programme at six weeks. That is 
after attendance at 8-12 sessions. This is so change can be measured over time. 
The researcher will seek consent to access this data for all those service users who 
attend either of the two participating programmes during the intervention period.  

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This data will be available at individual service user level if service users give 
informed consent. This data is stored on the services databases. Only anonymised 
data will be shared with the researcher. 
Additional anonymised demographic data of attendees, that is routinely collected by 
the services, will be shared with the researcher. This data will include gender, 
ethnicity, age and index of multiple deprivation. 
Primary and secondary outcomes for each of the two participating services will be 
collected. The outcomes are: 
Primary outcomes 
• LLBD Weight Management Programme:  Weight in kilograms  
• Pulmonary Rehabilitation Programme: The Chronic Respiratory Disease 
Questionnaire (CRDQ). 
Secondary outcomes  
• LLBD Weight Management Programme: The short form Warwick and 
Edinburgh Mental Health and Wellbeing Scale  
• Pulmonary Rehabilitation Programme: Incremental shuttle walking test (in 
meters), Lung Information Needs Questionnaire (LINQ), Generalised Anxiety 
Disorder Assessment (GAD -7), Patient Health Questionnaire 9 (PHQ-9) and 
strength tests. 
 
The weight management programme collects service users’ weight at 0, 12 and 26 
weeks. They collect the short form Warwick and Edinburgh Mental Health and 
Wellbeing Scale at 0 and 12 weeks.  
The pulmonary rehabilitation service collects all measures at 0 and 6 weeks. 
We will collect data at baseline and at the end of the programme for both services. 
That is: 
• 0, 12 and 26 weeks (weight only) for the weight management programme.  
• 0 and 6 weeks for the pulmonary rehabilitation programme.  
 

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3.6. Assessment of service users’ subjective Health Literacy skills and health 
activation 
Services users will be asked to complete an additional questionnaire as part of the 
research. This will be two domains of the validated Health Literacy Questionnaire 
(Osborne et al; 2013). This is to understand whether their subjective Health Literacy 
and health activation skills have changed after attending the programmes by Verbal 
Health Literacy trained or non-trained staff.  
The questionnaires will be completed at the same time as the routinely collected 
service data, that is the secondary outcomes for each service, at baseline, 6 weeks 
(pulmonary rehabilitation service) and 12 weeks (weight management service). 
Service users will complete the questionnaire either electronically or in paper form as 
per the services current data collection practice. Or they will be posted to participants 
for them to complete and return. The mode of delivery will depend on the service’s 
preference in order to minimise any extra burden on service staff during the research 
period. 
 Consent will be gained from all service user participants prior to collecting their data.  
 
3.7. Assessment of changes in outcomes (at a service level) 
 
Aggregate programme level data will be obtained from the two services for a three - 
six month period in 2024 when trained staff have delivered programmes and a 
corresponding three- six month period in 2023. This will allow comparable 
measurement of change over time at a service level. 
For the weight management service, a control group will consist of programmes run 
by non-trained staff. The same aggregated data will be obtained for this control 
group.  Individual level patient data will not be shared with researchers because not 
all service users will have consented to this.   
The aggregate data will include: 
 

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For both services 
• Attendance numbers 
• Did Not Attend (DNA) numbers and programme completion rates. 
• Summarised demographic data of attendees to include numbers and % by 
gender, ethnicity, age group and index of multiple deprivation quintile. 
 
LLBD weight management programme 
• Mean weight and standard deviation at baseline, 12 weeks and 26 weeks 
• Mean weight loss and standard deviation between baseline and 12 weeks, 
and between baseline and 26 weeks. 
• Mean score on the short form Warwick and Edinburgh Mental Health and 
Wellbeing Scale and standard deviation at baseline and 12 weeks. 
• Mean change in the short form Warwick and Edinburgh Mental Health and 
Wellbeing Scale and standard deviation between baseline and 12 weeks s. 
Pulmonary rehabilitation programme 
• Mean CRDQ score and standard deviation at baseline and six weeks. 
• Mean change in CRDQ score between baseline and six weeks. 
• Mean score in incremental shuttle walking test, LINQ, GAD-7, PHQ-9 and 
strength test and standard deviation at baseline and six weeks. 
• Mean change in incremental shuttle walking test, LINQ, GAD-7, PHQ-9 and 
strength test between baseline and six weeks. 
• Mean change % of service users with Acute respiratory/COPD exacerbation 
between the same period in 2023 and 2024 (if data available). 
• Mean change in % hospital attendance or admission between the same 
period in 2023 and 2024 (if data available).  
 
3.8 Recruitment 
We will recruit staff delivering Verbal Health Literacy training during a three month 
period in 2024.  

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We will recruit service users from two services, one within Derbyshire Community 
Health Services NHS Trust and one within the Local Authority. Service user 
recruitment is likely to take place over a six month period to recruit the minimum 
required sample. This is because both services run on a rolling basis. That is week 1 
for one person could be week 6 for another.  
We will recruit service users who enrol on the 12 week weight management 
programme and 6 week pulmonary rehabilitation programme after staff have (or 
have not) attended the Verbal Health Literacy training.  
That is: 
• Public Health Intervention Advisors and service users from the Live Life Better 
Derbyshire tier two weight management service. 
• Physiotherapists, specialist nurses and service users from the Derbyshire 
Community Health Services (DCHS) pulmonary rehabilitation service. 
Recruitment will commence once HRA and NHS ethics approval is obtained. Written 
informed consent will be gained for all participants in the study. 
3.8.1 Inclusion and exclusion criteria  
Inclusion criteria: 
• Public Health Intervention Advisors delivering the tier 2 weight management 
programme across Derbyshire. 
• Physiotherapists and specialist nurses involved in the assessment of patients 
and delivery of the six week DCHS NHS pulmonary rehabilitation programme. 
• Adults aged 18 or over who start the rolling 12 week tier two weight 
management programme during the intervention period. 
• Adults aged 18 or over, with Chronic Obstructive Pulmonary Disease, who are 
being assessed for and undertaking the six week pulmonary rehabilitation 
programme during the study intervention period. 

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• For the staff questionnaire only - Healthcare staff from other services that 
attend Verbal Health Literacy training, during the study period in 2024, will 
also be eligible.  
Exclusion criteria: 
• Service users attending the two service programmes outside of the data 
collection period. 
• Other pulmonary rehabilitation staff. i.e. staff who are not physiotherapists or 
specialist nurses. 
3.8.2 Process of recruitment  
Recruitment of staff will be carried out with the advice and assistance of the service 
leads. The study will be presented to each of the participating services by the lead 
researcher prior to recruitment commencing. An email invitation will be sent to all 
staff that deliver the programme in the two services via the service leads in the first 
instance. The email will include the study’s participant information sheet. This 
information will include the lead researcher’s contact details. This is so those staff 
who receive the Verbal Health Literacy training can get in touch should they be 
interested in taking part in the observations and focus groups or if any staff wish to 
discuss the project further.  
In addition, all staff across DCHS and DCC that receive the Verbal Health Literacy 
training during the period of the study will be invited to participate via the pre and 
post training questionnaires. Participant information will be included with the 
questionnaires. Staff will be able to consent to their data being used for the research 
at the start of the questionnaire. 
All service users that are referred or self-refer into the programmes during the period 
of the study, after staff have (or have not) been trained, will be invited to take part. 
Potential service user participants will be identified and approached by a member of 
their direct care team in the first instance. Because both programmes are rolling 
programmes, this means service users start their programmes at different times. 
Also, both services run across a number of different venues in Derbyshire. This 

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means it will be very difficult for the lead researcher to obtain face to face consent 
from service users. For this reason a number of different options for recruitment and 
consent will be used.  
• A link to the study information and consent form will be included in the 
programme enrolment email that the services send out. Potential participants 
will be able to read this, contact the researcher for more information if they 
wish, and complete the consent form electronically if they would like to take 
part. This information and consent form will be delivered via The University of 
Sheffield information governance approved online survey platform, Qualtrics 
(Qualtrics.com). 
• Those service users who cannot or do not wish to correspond via email will be 
given the one page project summary information sheet by the member of staff 
that enrols them on the programme. The member of staff will ask the service 
user if their contact details can be shared with the lead researcher. The lead 
researcher will then contact potential service user participants by their 
preferred mode of contact (telephone or email) to invite them to take part. 
They will include the full participant information sheet with this 
correspondence (via email, post or verbally). 
•  Alternatively service users may contact the researcher themselves using the 
contact information on the summary information sheet.  
A project information audio/video will be made available to all service users who are 
interested in taking part. This will be an alternative to the written information. 
Informed consent will be gained from all participants, electronically, over the 
telephone or by post in some instances where this is the participants preference. 
Prior to collecting or using any of their individual level data. 
3.9 Sampling strategy and sample size 
3.9.1. Staff  
There are currently eight staff that deliver the weight management programme. 
There are currently six physiotherapists and two specialist nurses who deliver the 

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pulmonary rehabilitation programme.  Four out of the eight weight management 
programme staff will receive the Verbal Health Literacy training. Six physiotherapists 
and two specialist nurses from the pulmonary rehabilitation programme will receive 
the training. All staff from the two participating services who receive the training, 
n=12, and from the wider services who complete the training during the study period, 
will be asked to complete the three questionnaires.  
All trained staff, from each of the two services (n=12) where possible, will be 
observed pre and post the intervention and be part of the focus groups.  
3.9.2. Service users’ individual outcomes 
LLBD Weight Management Programme 
Between 15-25 people attend each 12 week rolling LLBD weight management 
programme. 33 programmes are likely to be ongoing between the three month study 
period in 2024, with a minimum and maximum of 495 and 825 service users joining 
in total. All service users starting the programmes during the period of the study will 
be invited to take part when they sign up. We estimate there will be approximately 
660 attendees to the LLBD weight management programme. With a response rate of 
50% to our request to participate in the evaluation, we expect there to be weight, 
health and wellbeing and Health Literacy scores at three time points for 
approximately 330 service users. Approximately 160 service users will be in groups 
led by trained and 160 in groups led by untrained staff. We expect to see a reduction 
in weight, an improvement in clinical outcomes and an improvement in wellbeing 
between baseline and 12 weeks and baseline and 26 weeks for both groups. We 
expect the changes to be larger in the trained group versus the untrained group. We 
expect there to be an improvement in Health Literacy domain scores between 
baseline and 12 weeks (the end of the program) for the trained group and no change 
for the untrained group. 
DCHS Pulmonary Rehabilitation Programme 
Between 8-12 people attend the six week rolling programme across 6 venues. If we 
do two cohorts, there will be a minimum of 96 and a maximum of 144 service users 

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joining the programme between the three month study period in 2024, and who will 
be invited to take part. With a response rate of 50% to our request to participate in 
the evaluation, we expect there to be clinical, health and wellbeing and Health 
Literacy scores at two points of time for approximately 72 service users. We expect 
to see improvement in the CRDQ and other secondary outcomes after attending the 
programme. We expect there to be an improvement in Health Literacy domain 
scores between baseline and 6 weeks after the end of the programme. 
3.9.3 Outcomes at a service level 
For the aggregate outcomes for each service, we will use summarised data only. 
LLBD Weight Management Programme sample size calculation 
From January to March 2023 the mean starting weight was 103.68kg. The mean 
weight on completion of the 12 week course was 99.60kg. So, the mean weight loss 
was 4.08 kg for this cohort. This was larger than the mean weight loss of 2.3 kg for 
behavioural weight management interventions in primary care at 12 months 
compared with controls (Madigan et al, 2022). But people can gain weight after initial 
loss so we are happy to use the historical Derbyshire data to help calculate a 
required sample size.   
We expect the mean weight loss for the Derbyshire service to be larger in 2024 than 
in early 2023 potentially due to the health literacy training but also likely to be related 
to improvements management have made to the service between 2023 and 2024. 
We would expect a minimum of a 10% increase in the mean weight loss in the 
trained group vs. untrained group at 12 weeks, that is, 4.7kg vs. 4.3kg. With an 
estimated pooled standard deviation of 1.6, a sample size of 252 would be required 
in each group to detect this size of difference with 80% power at a 5% level of 
significance. As stated earlier there will be approximately 330 service users in each 
group who can be invited to take part. We therefore should be able to recruit 
sufficient numbers (252) to ensure we will be able to detect an improvement in 
weight loss over time at a service level. 
 

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 DCHS NHS Pulmonary Rehabilitation Programme   
We would expect the increase in the mean CRDQ score at 6 weeks in 2024 (post 
training) to be larger than the increase in the mean CRDQ score in 2023 (pre 
training). We are unlikely to have statistical power to detect small differences based 
on numbers of service users if we limit the ‘post’ time period to the three month study 
period in 2024 and the corresponding ‘pre’ time period in 2023. We need to extend 
this request for data to cover a six month period.  
3.10 Data analysis 
The study will produce both qualitative data and quantitative data. The analysis of 
the different types and sets of data will occur separately.  
3.10.1 Qualitative data 
The qualitative data will be analysed based upon Framework analysis (Ritchie & 
Lewis, 2003).  Analysis will follow the four stages of this approach: familiarisation, 
identification of a thematic framework, charting, and then mapping and theorising. A 
spreadsheet or code book will be used to organise and compare and contrast the 
data (Richie & Lewis 2003). NVIVO 12, an electronic qualitative data management 
tool, will be used to store and organise the data.   
3.10.2 Observations 
There will be 24 completed checklists for 12 members of staff observed before and 
after the training. For each health literacy technique, a 2x2 table will be created. This 
is so we can compare the % of Verbal Health Literacy technique used, most/all of the 
time versus sometimes/never, pre training and post training. We will make this 
comparison using McNemar’s Test.  
3.10.3 Quantitative staff data 
The three staff questionnaires will be analysed separately because they each ask a 
different set of questions. Analysis will be descriptive e.g. showing the percentage 
staff finding the training helpful or not, and using it in practice or not. We will also test 
relationships between variables from different time periods. In particular we will give 

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each staff member a unique ID and compare their experiences after the training and 
two months later to see if staff who found the training helpful report that have been 
able to continue to use the techniques. We are undertaking this analysis on all staff 
receiving training from any service, not just the 12 staff from the weight management 
and pulmonary rehabilitation services.  
3.10.4 Individual service user outcome data 
LLBD Weight Management Programme 
For the individual level outcome data, the analysis will be descriptive, displaying 
mean weight loss, mean short form Warwick Edinburgh score, and mean scores for 
the Health Literacy Questionnaire domains at the three time points. Then multiple 
regression will be used to test differences in changes in means between baseline 
and 12 weeks in the trained and untrained groups. We will also consider whether 
people who had an improvement in the Health Literacy Questionnaire domains were 
more likely to have better outcomes.   
DCHS Pulmonary Rehabilitation Programme 
For the individual level outcome data, the analysis will be descriptive, displaying 
mean CRDQ score, incremental shuttle walking test, LINK, GAD, PHQ-9 and 
strength test scores. Then multiple regression will be used to test for changes in 
means between baseline and six weeks. We will also consider whether people who 
had an improvement in the Health Literacy Questionnaire domains were more likely 
to have better CRDQ scores.  
3.10.5 Aggregate service data 
For the aggregated outcome data we will compare mean change in an outcome in a 
three month period before the training and in the three month period after the training 
for trained and untrained groups.  Means and standard deviations will be provided by 
the services, that is, no individual data will be shared with researchers.  
To meet the final objective, we will compare the IMD quintiles for attendees at the 
programmes in the three month period post-training with the IMD quintiles for the 

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Derbyshire population. The expectation is that the % of people in socially deprived 
quintiles will be higher for the programmes than for the Derbyshire population.  
SPSS and Excel spreadsheets will be used to store, organise and assist in analysis 
of the quantitative data from multiple sources.   
4. Ethics  
Important ethical considerations for this mixed methods study include: 
Informed Consent- Informed consent will be gained from all participants prior to 
their involvement [or their individual data being used]. This will ensure they have a 
clear understanding of what the research project is and what it is hoping to achieve 
through their involvement. Gaining informed consent will ensure participants 
understand and are happy with their role in the research. It will also make sure they 
understand what will be done with the data that will be collected from them.  
Participant information sheets will be made available to all interested participants. 
They will have ample opportunity to read this and talk through any queries with the 
Lead Researcher prior to agreeing to participate. They will then sign a consent form 
immediately prior to being observed/recorded/completing outcome measure 
questionnaires/giving access to their clinical details /being interviewed. There will be 
separate consent forms for the different data collection methods. Participants will be 
informed that their participation is voluntary and that they can withdraw at any time if 
they wish. 
Low Literacy/English as a second language-   It is likely that some of the service-
users invited to participate in the study will have low literacy skills or English as a 
second language. In order to address this, study materials will be written in plain 
English and designed in conjunction with the Health Literacy Officer and the project 
partnership group. A project information video will also be made available. When 
taking consent the Lead Researcher will go through each point with participants 
individually and summarise in plain language. 
Coercion and Inconvenience – Recruitment to research projects is difficult 
especially when recruiting busy healthcare/public health workers working in time 

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pressured and target driven environments. Participants will not be made to feel 
under any pressure to participate and their participation should be voluntary. 
Maintaining confidentiality- This study will involve collecting a range of staff and 
patient data including clinical data. Confidentiality will therefore be extremely 
important and will be maintained throughout the study. All data collected will be 
anonymised/pseudonymised.  The relevant information governance and information 
security procedures will be followed pertaining to the specific types of data that will 
be accessed and or generated. 
 
5. Data management 
 
A data management plan will be completed to ensure the appropriate information 
governance practices are followed according to NHS, local government and 
University policies. Confidentiality and data sharing agreements will be put in place 
where appropriate, to ensure data from the NHS and local authority services is 
shared safely and securely between them and the University research team. 
6.Timescales 
(Ethics outcome dependent)-   
June- July 2024 - Recruitment of staff participants and pre intervention staff 
observations. 
July- August 2024 - Delivery of training package and pre and immediately post 
intervention staff questionnaires. 
July – November 2024 – Recruitment of service users and baseline outcome 
measures and Health Literacy Questionnaire data collection. 
August– February 2025 – Service user post intervention outcome measures and 
Health Literacy Questionnaire data collection. 
 September – October 2024 – Two month follow up staff questionnaires. 
October – November 2024 – Post intervention staff observations and/or recording of 
consultations. 

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November - January 2025 – Staff focus group interviews. 
August 2024– March 2025 - Data analysis. 
January – March 2025 – Write report/disseminate. 
7. Patient and Public Involvement and Engagement 
A project partnership (advisory) group, including staff, patients and the public from 
the participating services as well as wider services within Derbyshire Community 
Health Services and Derbyshire County Council will provide advice and 
recommendations regarding recruitment, analysis and interpretation. They have 
helped to develop easy read versions of documents e.g. the participant information. 
Their knowledge and experience will be utilised to inform decision making and 
analysis. They will be key in ensuring the results of the study are presented in a way 
that is meaningful and easy to understand to a wider audience not just academics 
and NHS and Local Authority managers. 
8.Dissemination and impact 
An event will take place at the end of the study to present the findings to Derbyshire 
Community Health Services and Derbyshire County Council. 
A final report will be written and circulated to Derbyshire Community Health Services 
and Derbyshire County Council. An easy read summary of the report will also be 
produced. 
The outcomes of the research, positive or negative, will be disseminated in a peer 
reviewed publication and presented at a national conference. NHS and Local 
Authority communication networks for Trusts and Commissioners will be used to 
ensure the findings reach appropriate audiences. If there is no change in patient 
outcomes the focus of dissemination will be on why outcomes did not improve and 
describe how the programs might be improved to increase their chance of impacting 
on patient outcomes in the future. This will help commissioners and service providers 
to gauge the value of Verbal Health Literacy training programs and make decisions 
about funding and future content of programs. 
 

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9.Expertise of the researcher and associated team 
Dr Cheryl Grindell will lead the research and is a Research Associate at the 
University of Sheffield. Cheryl Grindell is a mixed methods researcher with 
experience of working closely with health services to develop and evaluate 
interventions. Professor Alicia O’Cathain will offer senior oversight for the project. 
She is Director of the Health and Care Research Unit at the University of Sheffield. 
She is a mixed methods researcher and statistician who had led numerous 
evaluations of health service interventions. Laura Walton-Taylor is a Psychologist 
and Health Literacy Officer for Joined up Care Derbyshire, Jane Hawley is a 
Healthcare Public Health Practitioner, Derbyshire County Council and Dr Jo Hall is 
Derbyshire Psychological Insights team lead. These team members will offer 
expertise in the intervention and needs of the Integrated System. 
10.Project management  
The University of Sheffield will have overall responsibility for the study along with the 
research lead. The study will be registered with the local Research & Development 
 and Knowledge and Innovation departments. The research team will meet monthly to 
progress the study. 
 
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