A Feasibility Study Evaluating the Impact of Differing Completion Rates of a Face-to-face Diabetes Self-management Education Programme on Patient Reported Outcome Measures.
Phase: NA
Conditions: Diabetes Mellitus, Type 2, Patient Education as Topic
Sponsor: University of Liverpool

 
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Full Study title 
A feasibility study evaluating the impact of differing completion rates of a face-to-face diabetes self-
management education programme on patient reported outcome measures. 
Short Study Title or Acronym 
Differing completion rates of DIABETES education on Patient Reported Outcomes (DIABETES-PRO 
study) 
Protocol Version number and date 
Version: 1.1.0 
Date: 27.03.24 
Research Reference Numbers 
IRAS Number: 
337691  
Sponsor Reference Number: 
UoL001848 
Student Number: 
201781864 

 
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Signature Page 
The undersigned confirm that the following protocol has been agreed and accepted and that the Chief 
Investigator agrees to conduct the study in compliance with the approved protocol and will adhere to the 
principles outlined in the Declaration of Helsinki, the Sponsor’s SOPs, and other regulatory requirement. 
I agree to ensure that the confidential information contained in this document will not be used for any other 
purpose other than the evaluation or conduct of the investigation without the prior written consent of the 
Sponsor. 
I confirm that I will make the findings of the study publicly available through publication or other dissemination 
tools without unnecessary delay and that an honest, accurate and transparent account of the study will be given.  
Any discrepancies from the study as planned in this protocol will be explained. 
 
For and on behalf of the Study Sponsor: 
Signature:  
...................................................................................................... 
 
Date: 
....../....../...... 
Name (please print): 
Mrs Karen Jennings-Wilding 
 
 
Position: 
Senior Clinical Research Governance Manager 
 
 
 
 
Chief Investigator: 
Signature: .............................. 
 
Date:  
 
Name: (please print): 
........................................................  
 
 
 
 
 

 
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Key Study Contacts 
Chief Investigator 
Professor John Wilding* 
Department of Cardiovascular and Metabolic Medicine Institute of 
Life Course and Medical Sciences  
Clinical Sciences Centre 
Aintree University Hospital  
Longmoor Lane 
Liverpool 
L9 7AL 
United Kingdom 
 
Direct Line +44(0)151 529 5899 
Fax +44(0)151 529 5888 
Email: j.p.h.wilding@liverpool.ac.uk 
 
Academic Secretary - Christine Greenwood +44(0)151 529 5885 
c.greenwood@liverpool.ac.uk 
 
Study Co-ordinator, protocol author 
Gemma Lewis* 
Mersey & West Lancashire Teaching Hospitals NHS Trust  
Diabetes Centre,  
St Helens Hospital,  
Marshalls Cross Road,  
St Helens,  
Merseyside,  
WA9 3DA 
 
Direct line: 01744 646668 
Mobile: 07803061858   
Email: gemma.lewis@sthk.nhs.uk / gemma.lewis@liverpool.ac.uk  
 
PhD student researcher, University of Liverpool. Subsequently 
referred to in this document as ‘the researcher’. 
Contact for Clinical Queries  
Dr Kevin Hardy* 
Mersey & West Lancashire Teaching Hospitals NHS Trust,  
Diabetes Centre 
St Helens Hospital 
Marshalls Cross Road 
St Helens  
Merseyside 
WA9 3DA 
 
PA: +44 (0)1744 646497 
Email: kevin.hardy@sthk.nhs.uk  

 
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Sponsor 
The University of Liverpool is the research Sponsor for this Study.  It 
is recognised that as an employee of the University the Chief 
Investigator has been delegated specific duties, as detailed in the 
Sponsorship Approval letter. 
For further information regarding the sponsorship conditions, please 
contact: 
Mrs Karen Jennings-Wilding 
Senior Clinical Research Governance Manager 
Sponsor@liverpool.ac.uk  
Key Protocol Contributors 
Dr Kevin Hardy* 
Email: kevin.hardy@sthk.nhs.uk 
Professor Greg Irving* 
Email: irvingg@edgehill.ac.uk 
Committees 
This research proposal will be submitted to IRAS for independent 
ethical opinion by the Health Research Authority.  
University of Liverpool Committee on Research Ethics** (online 
ethical approval process completed – confirmed that IRAS approval 
required) 
*CV in appendix 1. ** University of Liverpool research ethics application project ID 13707. 
Study Summary 
Study Design 
Quantitative feasibility study 
Study Participants 
People with type 2 diabetes mellitus 
Planned Size of Sample (if applicable) 
120 people with type 2 diabetes.  
Participants will be randomised across four groups, each with 30 
participants.  
Follow up duration (if applicable) 
4 months 
Planned Study Period 
This is educational research which is being undertaken to fulfil the 
requirements of a 3-year full time PhD with University of Liverpool 
commencing November 2023. 
GANNT chart detailing timetable of research activities in appendix 

 
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1.  
Research Question/Aim(s) 
 
Aims 
Using a quantitative approach this feasibility study aims to explore 
if patients who attend minimal aspects (10%) of diabetes self-
management education (DSME) programmes gain clinically 
significant improvements in ability to self-care compared to those 
who do not attend. If the nationally accepted 60 % completion rate 
is as effective as 100% completion, and if   
Research question 
1. What is the impact of differing completion rates of DSME 
programmes on ability to self-care (primary outcome), 
diabetes distress and health related quality of life in type 2 
diabetes. 
 
Abstract 
Background: Structured diabetes self-management education (DSME) is internationally recommended for all 
people with newly diagnosed type 2 diabetes and is designed to support patients in self-managing their condition 
and prevent associated long-term complications.  DSME is proven to be as effective as pharmacotherapy in 
preventing diabetes associated morbidity and premature mortality but attendance at both a national and local 
level remains poor.  Local records suggest that of those that start DSME (9%) only 12.6% complete the 
programme. Attendance at DSME is currently benchmarked as having completed a registration form and had at 
least one active engagement with a programmes content, with ‘completion’ measured against ≥60% completion 
despite landmark trials reporting outcomes based on the full completion of a programme.  Little is known, of the 
effectiveness of DSME on the psychological and emotional health of people with diabetes who complete less 
than the full DSME programme. 
Aim: This feasibility study will test the impact of differing completion rates of a face-to-face DSME programme 
on patient reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 
diabetes. 
Methods: Using a quantitative approach, a single centre, randomised feasibility study will be conducted, aiming 
to recruit 120 eligible people with type 2 diabetes due to attend a secondary care diabetes clinic in the Northwest 
UK for specialist support, education and advice.  Participants will be randomised into one of four groups:  Group 
1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have 
delayed education.  Normal clinical care will continue.  Preliminary outcomes (psychometric questionnaire scores 
measuring ability to self-care, diabetes distress and health related quality of life) will be evaluated at baseline 
and 3-4 months post-intervention.  Measures of feasibility (eligibility, recruitment and retention rates) will be 

 
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reported.  
Original contribution to knowledge: Whilst the current literature evidences the clear benefits for people with 
type 2 diabetes attending DSME programmes, there is minimal understanding of the benefits of partial DSME 
completion on a person’s ability to self-care despite national consensus accepting 60% attendance as 
‘completed’.  The proposed research aims to test the feasibility of conducting a full randomised control trial to 
evaluate the effectiveness of DSME programmes on psychometric outcomes with differing completion rates.   
Lay Summary 
Type 2 diabetes accounts for 90% of all diabetes diagnoses.  Without proper care, type 2 diabetes can result in 
complications such as stroke, heart disease, kidney disease, eye disease and nerve damage.  On average, a person 
with diabetes spends less than three hours a year with a healthcare professional meaning patients must manage 
their own diabetes almost 100% of the time.  Diabetes self-management education plays an important role in 
helping people stay healthy, live well, and avoid life threatening complications and is proven to be effective in 
lowering blood glucose levels and preventing health problems later in life.  Despite an increased awareness of 
the importance of education for people with type 2 diabetes, attendance at education programmes remains very 
poor with little to no change over the past decade.  
Many things can prevent attendance or completion of education programmes, including physical and mental 
health issues, reduced finances, work and childcare commitments, location of education programmes and lack 
of information on programme content or availability.  Little is known on the effectiveness of only attending part 
of an education programme on a person’s ability to self-care.   
This study will examine the impact of differing completion rates of diabetes self-management education 
programmes on a person’s self-care skills.  The psychological impact of not completing a diabetes self-
management education programme is unknown and a better understanding of this could help tailor future 
education offers for people with type 2 diabetes.  This is a smaller study to see if a larger project is feasible in the 
future.    
Funding and Support in Kind 
FUNDER(S) 
FINANCIAL AND NON-FINANCIAL SUPPORT GIVEN 
Department of Endocrinology and Diabetes, 
St Helens Hospital, Mersey and West Lancashire 
Teaching Hospitals NHS Trust.  
Funded clinical research fellow post and PhD fees at 
University of Liverpool.  
Postage costs for patient information sheets to patients 
 
Roles and Responsibilities of Study Sponsor and Funder 
The sponsor of this study is University of Liverpool where the researcher is currently registered on her full-time 

 
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3-yr PhD.  The University of Liverpool is a member of the prestigious Russell Group of UK research intensive 
institutions and is internationally recognised with 91% of its research being ranked as world-leading and 
internationally excellent in the latest Research Excellence Framework. As the study sponsor, the University of 
Liverpool is responsible for the initiation and management of the research and takes primary responsibility for 
ensuring that the design of the study meets appropriate standards.  
The funder is the Diabetes Centre, St Helens Hospital, Mersey and West Lancashire Teaching Hospitals NHS Trust 
who will provide the working environment and resources for the clinical research fellow post to which the 
researcher is employed.  
Service user involvement 
The DIABETES-PRO study design and justification have been discussed with a service user living with 
diabetes. Having completed previous education programmes they were shocked by the low number 
that attend DSME programmes and that a record of ‘attended’ required minimal engagement with a 
programme, or that a patient is classes as ‘completed’ following engagement with >60% of a 
programme. The service user was reassured that all patients would be offered a full education 
programme at the end of the study and thought the offer of a home visit or telephone appointment to 
reduce the burden on patients to attend an additional appointment at the end of the study (follow up 
visit) was important. 
Templates from the Health Research Authority (HRA) have been adopted for use in this study to ensure 
that participant information sheets and consent forms are easy to read and contain the required 
information to support participants in making an informed choice. 
Peer review  
Peer review has been completed and submitted to the sponsor. Copies of peer review feedback is included in 
Appendix 1. The internal peer reviewer (Consultant Physician/Diabetologist) and external peer reviewer 
(Physiotherapy Lecturer and Researcher) both approved the study.  Comments are summarised below, with 
accompanying amendments. 
 
1. Clarify the role of the researcher in supporting participants (minor). Section 6.2 Study processes updated 
and Section 9 Adverse events updated to include table 5.   
 
Protocol Contributors 
Author of the protocol: Gemma Lewis 
Supervision / advice: Dr Kevin Hardy, Professor John Wilding, Professor Greg Irving.  
The PhD student will undertake this research as part of a research PhD at the University of Liverpool. The study 
sponsor (University of Liverpool) and funder (Mersey and West Lancashire Teaching Hospitals NHS Trust) will 

 
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control the final decision on study design, conduct, data analysis and interpretation , manuscript writing and 
dissemination of results.  
James Lind Alliance top 10 priorities for type 2 diabetes have informed the aims and objectives for this research 
protocol (1).  
Key Words: 
type 2 diabetes mellitus; patient education as topic; patient 
reported outcome measures; health education;  
 

 
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Study Flow Chart 
 

 
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Figure 1: Study flow chart 
Glossary of Abbreviations 
HRA 
Health Research Authority 
REC 
Research Ethics Committee 
PIS 
Participant Information Sheet 
DSME 
Diabetes Self-Management Education 
PRO 
Patient Reported Outcome 
PROM 
Patient Reported Outcome Measure 
MCID 
Minimal Clinically Important Difference  
QISMET 
Quality Institute for Self-Management Education and Training 
 
HCPC 
Health and Care Professions Council 
 
HEA 
Higher Education Academy 
 
NICE 
National Institute of Clinical Excellence 
 
 
 

 
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Contents  
Research Reference Numbers ..........................................................................................................................1 
Signature Page ..................................................................................................................................................2 
Key Study Contacts ...........................................................................................................................................3 
Study Summary .................................................................................................................................................4 
Funding and Support in Kind ............................................................................................................................6 
Roles and Responsibilities of Study Sponsor and Funder .................................................................................6 
Protocol Contributors .......................................................................................................................................7 
Key Words:........................................................................................................................................................8 
Study Flow Chart...............................................................................................................................................9 
Glossary of Abbreviations .............................................................................................................................. 10 
INTRODUCTION ................................................................................................................................................. 13 
BACKGROUND ................................................................................................................................................... 13 
RATIONALE FOR CURRENT STUDY ..................................................................................................................... 16 
THEORECTICAL FRAMEWORK ............................................................................................................................ 17 
4.1 Null hypothesis ........................................................................................................................................ 17 
RESEARCH QUESTION ........................................................................................................................................ 18 
5.1 Research question ................................................................................................................................... 18 
5.2 Outcome .................................................................................................................................................. 18 
STUDY DESIGN AND METHODS OF DATA COLLECTION ..................................................................................... 18 
6.1 Design ...................................................................................................................................................... 18 
6.2 Study processes ....................................................................................................................................... 19 
6.3 Data Collection ........................................................................................................................................ 22 
6.4 Data Analysis............................................................................................................................................ 23 
6.5 Data Storage ............................................................................................................................................ 23 
STUDY SETTING .................................................................................................................................................. 24 
SAMPLE AND RECRUITMENT PARTICIPANT ENTRY ........................................................................................... 24 
8.1 Eligibility Criteria ...................................................................................................................................... 24 
8.2 Recruitment ............................................................................................................................................. 25 
ADVERSE EVENTS ............................................................................................................................................... 27 

 
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9.1 Definitions ............................................................................................................................................... 27 
9.2 Reporting procedures .............................................................................................................................. 28 
10. REGULATORY ISSUES.................................................................................................................................... 32 
10.1 Ethical Approval ..................................................................................................................................... 32 
10.2 Confidentiality ........................................................................................................................................ 32 
10.3 Indemnity ............................................................................................................................................... 33 
10.4 Audits ..................................................................................................................................................... 33 
10.5 Document Control ................................................................................................................................. 33 
11. END OF STUDY ............................................................................................................................................. 33 
12. DISSEMINIATION POLICY ............................................................................................................................. 33 
12.1 Dissemination policy ............................................................................................................................... 33 
13. ARCHIVING ................................................................................................................................................... 34 
14. REFERENCES ................................................................................................................................................. 35 
15. Appendices .................................................................................................................................................. 42 
15.2 
Appendix 2 – Amendment History .................................................................................................... 44 
 
 
 

 
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INTRODUCTION 
This protocol describes ‘A feasibility study evaluating the impact of differing completion rates of a face-to-face 
diabetes self-management education programme on patient reported outcome measures and provides 
information about procedures for entering participants, study procedures, safety reporting and governance 
requirements. Every care was taken in its drafting, but corrections or amendments may be necessary.  These 
will be circulated to investigators in the study following receipt of required approvals. 
Queries relating to this study should be referred in the first instance to the researcher or chief investigator.  
This study will adhere to the principles outlined in the UK Policy Framework for Health and Social Care Research. 
It will be conducted in compliance with the protocol, the Data Protection Act 2018 and the UK general data 
protection regulation as amended from time to time and any successor legislation in the UK and any other directly 
applicable regulation relating to data protection and privacy as well as any other regulatory requirements as 
appropriate. 
BACKGROUND 
Diabetes is a complex condition leading to increased disability and premature mortality; 7000 excess deaths in 
the United Kingdom in 2022 (2).  The International Diabetes Federation (IDF) estimate 537 million people are 
living with diabetes around the world (3) of whom approximately 4.3 million reside in the UK (4).  Over 90% of 
diagnoses are attributed to type 2 diabetes with an increased prevalence in areas with high levels of deprivation, 
poor access to healthcare, poorer housing, reduced finances, and lower levels of educational attainment (5).  
Presentation and disease progression of type 2 diabetes are heterogeneous, which can lead to delayed diagnosis, 
multiple abnormalities, and varying susceptibility to complications (6).  Complications are often classified as 
either microvascular, such as retinopathy, neuropathy, and nephropathy, or macrovascular including 
cardiovascular, cerebrovascular, and peripheral vascular disease (7).  
Diabetes prevalence in the UK has generally increased year on year since 2010/11 from less than 5% (8) to more 
than 7.3% in 2022/23 (9).  Public Health England identified the most common causes of morbidity in 2019 
according to global burden of disease, as measured by age standardised years lived with disability (YLDs) per 
100,000 population, with diabetes accounting for the second main cause in males (figure 2), and the seventh 
main cause of morbidity in females (figure 3) (8).  The YLD rate for diabetes mellitus increased significantly 
between 1990 and 2019 (males >2.3, females >2.2) (8).   In 2019 the USA had the highest burden of all cause 
morbidity in both males and females followed by England (and the UK), while Japan had the lowest, England had 
the highest rate of morbidity for diabetes in males and second highest for diabetes in females (8).  Whilst 
mortality specifically linked to diabetes has decreased (10), emergency admissions have increased more rapidly 
in areas of high deprivation when compared to those in the least deprived quintiles (11).  Increased incidence of 
diabetes is associated with Black and Asian ethnicity (12,13) and lower socio-economic status [17,18] which is 
associated with poorer outcomes and poorer compliance with diabetes treatments [19], including engagement 
with DSME [20] and a significantly greater mortality rate (14).  

 
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Figure 2: Male common causes of morbidity in England 2019 (8) 
 
 
Figure 3: Female common causes of morbidity in England 2019 (8) 

 
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NICE recommends DSME is offered at the point of diagnosis and annually thereafter for people with type 2 
diabetes (15).  Despite this, uptake of DSME remains poor (table 1) (9) with a discord between offered and 
attended figures at a local and national level with evidence suggesting DSME is equally as important as 
pharmacotherapy in the effective management of type 2 diabetes (15–17).  Negative perceptions of education 
remain an obstacle to adult learning and the uptake of DSME [22] despite a joint consensus by the American 
Diabetes Association (ADA) and European Association for the Study of Diabetes (EASD) (18) and NICE (15) all 
considering DSME as the foundation for successful management of diabetes, and for avoidance of associated 
metabolic co-morbidities and hospitalisation (19).   
Table 1: DSME figures of offer and attended within 12 months of diagnosis (9) 
DSME within 12 months of diagnosis 
St Helens % 
England % 
Offered 
68.9 
71.0 
Attended 
9.1 
7.0 
 
The National Diabetes Audit suggests 71% of people with type 2 diabetes are offered DSME, with an average 
attendance rate of 7%.  Local records suggest that of those that start DSME (9%) only 12.6% complete the 
programme (20), with those in a lower socioeconomic group harder to reach despite often needing the 
intervention the most (21).  Multiple studies have demonstrated poor attrition rates across DSME programmes 
meaning patients frequently do not receive the required number of hours or content (21,22).  NHS England (23) 
and the Center for Disease Control and Prevention (24) currently benchmark DSME attendance as completed a 
registration form and had at least one active engagement with a programmes content, with completion 
measured against ≥60% despite landmark trials (23,25–27) reporting outcomes based on full completion of a 
programme.  Evidence suggests the reasons for non-attendance and non-completion of DSME are multifactorial 
(28–31), with patients living in areas of high deprivation more likely to decline DSME programmes (30,32,33).   
The borough of St Helens has a legacy of poor health linked with deprivation and the town’s industrial past. St 
Helens is ranked as the 26th most deprived local authority in England, its relative position having deteriorated 
since 2015 with almost 25% of residents living in the 10% most deprived neighbourhoods in the country (34).  St 
Helens has widespread health deprivation with a higher-than-average diabetes prevalence of 9.2% (14,935 
individuals) (20), versus 7.3% in England (35).  Despite improvements in mortality rates over the last 20 years the 
borough’s mortality rate remains higher than the national average as seen in figure 4 (36), with two thirds of 
adults recorded as overweight or obese, 1 in 5 adults are physically inactive and less than 50% eat the 
recommended ‘5 a day’ (37).  

 
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Figure 4:All-age all-cause mortality trend 1999-2019 (36) 
 
RATIONALE FOR CURRENT STUDY 
Despite the current literature evidencing the clear benefits of DSME on behavioural choices, HbA1c levels and 
reduced risk of morbidity and premature mortality (38) attendance and completion levels remain poor.  There is 
minimal understanding of the impact of non-completion of DSME programmes on HbA1c or psychometric 
outcomes.  Positive endpoints for DSME studies are typically based on participants who complete the full 
programme (22) with HbA1c (39) used as a measure of effectiveness yet often studies fail to demonstrate 
significant or lasting results despite being statistically powered (38).  
There is scarce literature examining the impact of attrition on DSME effectiveness.  Although a small retrospective 
study in the USA using secondary data analysis of 105 patient records reported patients who attended 1 or 8 
hours or more of DSME had a significant reduction in HbA1C when compared to those who received no education 
(22).  Evidence is available looking at diabetes prevention programmes which suggests each session attended is 
linked to a reduction in body weight between 0.26-0.3% (24,40) suggesting a positive impact with any level of 
engagement.   

 
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Internationally the benchmark for recording a patient as completed DSME is attendance at ≥60% of a 
programme’s content (23,41–43), a discord with the literature measuring effectiveness of landmark studies at 
100% completion (25,39).  A record of DSME attendance is given for patients who sign up and engage with >10% 
of materials (23,41,43).   
There is no research available measuring the impact of non-completion on UK DSME programme effectiveness 
or internationally on the impact of differing completion rates on patient reported outcome measures (PROMs) 
despite the acceptance of completion (≥60%) at discord with legendary studies benchmarking completed at 
100%.  The aims of this study are to explore if patients who attend minimal aspects (10%) of DSME programmes 
gain clinically significant improvements in ability to self-care compared to those who do not attend, and if the 
nationally accepted 60 % completion rate is as effective as 100% completion.   
THEORECTICAL FRAMEWORK 
Philosophical assumptions (also referred to as epistemology) influence our views about how phenomena should 
be approached (44) assisting researchers in refining the types of evidence required, how it should be collected, 
and how it should be interpreted.  This quantitative study will adopt an experimental hypothesis driven design 
whereby the variable or intervention is controlled, with the exception of a control group, to attempt to establish 
causal effect of an intervention, in this case DSME completion rates. Whilst the most powerful and highly 
regarded form of experimental study remains the randomised control trial (RCT), this study will test the feasibility 
of conducting a full RCT.   
This study positions itself with critical realism, often thought to be a useful middle ground between the naive 
realism associated with quantitative research ‘what you see is what you get’ and the subjectivity given to 
interpretive sciences. (45).  Quantitative critical theory approaches are growing, complementing the objectivity 
afforded to quantitative designs with a social lens which considers social determinants of health.  Whilst with 
any scientific method in which hypothesis are formulated there are inherent limitations, among them the 
problem of induction which prevents researchers from generalising observations on a select sample to the wider 
population, a fatal flaw in the logic of scientific research as the implication is nothing can be certain.  Philosopher 
Karl Popper in 1935 acknowledged that whilst induction is a flaw in scientific research, the focus should not be 
in attempting to prove theories but trying to disprove them (46). The harder a researcher tries to disprove the 
null hypothesis the more confidence a reader should have in it (45).  The DIABETES-PRO study focus is not in 
discovering new health care interventions but merely to test current interventions with small samples and 
generalising through the logic of induction and sophisticated statistical tests to measure and compare the 
efficacy of differing DSME completion rates for people with type 2 diabetes by translating variables into 
numerical data, a method often thought to be reductionist by nature (47).  
4.1 Null hypothesis 
Differing DSME completion rates have no impact on a person’s ability to self-care, diabetes distress or health 
related quality of life.  

 
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RESEARCH QUESTION 
Using a quantitative approach this feasibility study aims to explore if patients who attend minimal aspects (10%) 
of DSME programmes gain clinically significant improvements in ability to self-care compared to those who do 
not attend, and if the nationally accepted 60 % completion rate is as effective as 100% completion on patient 
reported outcome measures.  
5.1 Research question 
1. What is the impact of differing completion rates of DSME programmes on ability to self-care (primary 
outcome), diabetes distress and health related quality of life in type 2 diabetes. 
5.2 Outcome 
The primary outcome measure will be measured as: 
• 
Change in self-care activities outcome measure (pre and post intervention) using the Diabetes Self-
Management Questionnaire - Revised (DSMQ-R) scale (48). 
Secondary outcome data will capture data on: 
• 
Change in diabetes distress (pre and post intervention) using the Problem Areas in Diabetes (PAID) tool 
(49). 
• 
Quality of life outcome measures (pre and post intervention) using the PROMIS-Global Health V1.2 
scale (50). 
Other preliminary data will explore whether deprivation and diabetes duration have any impact on PROMs 
across the four groups.   
 
STUDY DESIGN AND METHODS OF DATA COLLECTION 
This is a quantitative feasibility study focusing on the impact of differing completion rates of DSME programmes 
on psychometric outcomes pre and 4 months post intervention.  
6.1 Design 
This is a single-centre randomised feasibility study evaluating the impact of different completion rates of DSME 
programmes on psychometric outcomes specifically looking at ability to self-care, diabetes distress and quality 
of life. DSME will be the intervention and will typically be delivered within 3 weeks of the baseline appointment. 
There is a deliberate short separation between education intervention and follow up psychometric tests of 3-4 
months to allow participants the opportunity to adopt any behaviour changes following the DSME programme 
whilst minimising the risk of not receiving the full NICE recommended DSME programme and to broadly align 
with landmark studies.  Landmark studies namely DCCT (26,27) and DESMOND (25) evidenced a statistically 

 
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significant improvement to PROMs at 4 months post education intervention, however HbA1c changes were not 
significant within this timeframe despite being statistically powered.  A recent systematic review (38) concluded 
that as DSME is primarily focused on behavioural change to facilitate glycaemic control, efficacy measures should 
focus on behavioural and psychosocial changes, however these are often overlooked.  This study is a feasibility 
trial and by its very nature is not statistically powered, therefore despite HbA1c being arguably the measure of 
choice within the literature for measuring effectiveness of diabetes interventions, this study will use PROMs as 
its primary outcome measure.  
6.2 Study processes 
Screening and recruitment 
Potentially eligible participants meeting the inclusion criteria and not excluded by exclusion criteria (outlined in 
section 8.1) who are either due to attend the diabetes centre for new patient clinic, have been referred for DSME 
intervention or are on the monthly shared care report for newly diagnosed type 2 diabetes requiring an offer of 
DSME will be screened for entry into the study and added to a screening log sheet (appendix 1). Potentially 
eligible participants due to attend new patient clinic will be invited into the study by NP clinic letter (appendix 1) 
with attached participant information sheet (PIS) (appendix 1).  Letters will be posted ahead of their clinical 
appointment. For potential eligible participants identified through DSME referrals or the monthly shared care 
record report will be sent a telephone screening letter (Appendix 1) and PIS prior to meeting with the researcher.  
Study recruitment technique is outlined in further detail in section 8.2.2.  
At the screening meeting potentially eligible participants will be asked to confirm they have read the PIS and 
invited to ask questions about the research.  Where patients decline to take part in the research, they will be 
reassured this will not have any impact on their current or future treatment.  Participants who give written 
informed consent will be enrolled onto the study. The researcher will utilise an informed consent checklist 
(Appendix 1) to ensure consistency and that all elements for informed consent have been completed. 
Participants will be consented for informing their GP, this is made clear in the PIS.  
Visit 1 
At enrolment baseline characteristics will be recorded from the electronic medical record, or where not available 
directly from the patient: NHS number, age, sex, ethnicity, diabetes duration, postcode, latest HbA1c, prescribed 
glucose lowering agents, and a Charlson Comorbidity Index will be calculated.  Postcode will be used to calculate 
indices of multiple deprivation (IMD) score.  
Participants (n=120) will be randomised by permuted block strategy of 2:1 across four groups using an online 
randomisation software application designed for clinical trials (51,52).  Due to the design of this study 
randomisation will not be blind to the researcher or participants.  Group design will be as follows: 
• 
Group 1: DSME 6 hours, 100% completed (completed). 
• 
Group 2: DSME 3 hours 36 minutes, 60% completion (partial completion) 

 
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• 
Group 3: DSME 36 minutes, 10% of content (attended) 
• 
Group 4: Delayed education (education not offered, not attended, or declined)  
 
DSME programme overview is provided in appendix 1 giving a broad overview of DSME content by programme 
completion status.  Local demographic data suggests that of the local population 46.4% are living in the most 
deprived neighbourhoods within the UK (9). Of the local population 19.3% have a reading age of 9-11 or below 
(53,54), are classed as being functionally illiterate and are therefore likely to struggle reading a paper 
questionnaire.  Verbal support for completing the PROMs will be offered by the researcher to ensure participants 
from lower socioeconomic backgrounds are not excluded from participating in the DIABETES PRO study as they 
are evidenced to make up a larger proportion of people with diabetes (55–57). Support will be limited to reading 
the questions verbatim. 
Participants will be asked to complete three psychometric tests measuring self-care activities, diabetes distress 
and quality of life using the following validated tools: Diabetes Self-Management Questionnaire-Revised (DSMQ-
R)(48), Problem Areas in Diabetes (PAID) scale (49) and the Patient Reported Outcome Measures Information 
System (PROMIS) Global Health scale v1.2 (50) (appendix 1).   
Participants in groups 1, 2 and 3 will be asked to book a DSME session with the researcher, typically this should 
be no longer than 3 weeks from study enrolment.  Research group DSME programmes (intervention) will be run 
by the researcher separate to routine patient DSME to minimise disruption of participants leaving part way 
through on patients.   
Participants randomised to group 4, delayed education will not be required to attend DSME as part of the 
DIABETES PRO study.  Collected data will be collected and managed using Research Electronic Data Capture 
(REDCap) electronic data capture tools. A REDCAP data collection tool has been included in Appendix 1 for 
reference. REDCap is a secure, web-based software platform designed to support data capture for research 
studies, providing an intuitive interface for validated data capture; audit trails for tracking data manipulation and 
export procedures; automated export procedures for seamless data downloads to common statistical packages; 
and procedures for data integration and interoperability with external sources (58,59) (see section 3.6 for further 
details). 
Visit 2 
To ensure there is enough information about the intervention within this study particular consideration has been 
given to discussing areas the National Institute for Health Research (NIHR) report to be inadequately detailed in 
rejected health research proposals (60). See table 2.  
Table 2: NIHR adapted final checklist for health research proposals. (60) 
Organisation 
• 
What type of trust is involved? 
Mersey and West Lancashire Teaching Hospitals NHS Trust, 
previously St Helens and Knowsley Teaching Hospitals NHS Trust 

 
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• 
How big is the organisation? 
• 
How many study sites? 
and Southport and Ormskirk NHS Trust serves a population of over 
600,000 delivering care across 5 hospital sites, intermediate care, 
primary care, and community-based services.  
 
The specialist diabetes centre is based at St Helens Hospital and 
will be the single study centre for this research.  
 
Location 
• 
What type of area is it? 
• 
Population demographics 
The borough of St Helens has a legacy of poor health linked with 
deprivation and the town’s industrial past. St Helens is ranked as 
the 26th most deprived local authority in England, its relative 
position having deteriorated since 2015 with almost 25% of 
residents living in the 10% most deprived neighbourhoods in the 
country (34).   
 
St Helens has widespread health deprivation with a higher-than-
average diabetes prevalence of 9.2% (14,935 individuals) (20), 
versus 7.3% in England (35).   
Patient group 
• 
Who 
is 
receiving 
the 
intervention? 
• 
How many patients are being 
seen? 
• 
Characteristics of the patients? 
Patients with type 2 diabetes referred to the Diabetes Centre, St 
Helens Hospital for specialist intervention and / or DSME and / or 
registered with a St Helens GP and opted into data sharing will be 
screened for entry.   
 
The Diabetes department works closely with primary care 
colleagues to offer specialist advice, education, and guidance to 
patients with diabetes who are assessed and then discharged for 
clinical management by their GP. Referrals for DSME are made 
directly from primary care into DSME education sessions.  The 
shared care report highlights any patient with a local GP who has 
had a first use of a type 2 diabetes code within the last month and 
have opted into data sharing. The use of the three recruitment 
streams for this study allows for a sample which is representative 
of the local population and is not limited to only patients requiring 
specialist led care.   
 
The DIABETES PRO study will aim to recruit 120 participants which 
will be randomised across four groups containing 30 participants 
each.  
 
Patients ≥18 years of age from a variety of socioeconomic 
backgrounds. St Helens has a predominantly white British 
population (96.5%), and this is likely to represented in the sample 
(37). 
 
Workforce and staffing 
• 
Staffing 
skill, 
grade 
and 
The researcher is employed by the Diabetes Centre as a clinical 
research fellow and is a Fellow of the HEA with experience teaching 

 
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profession 
• 
Staff new or existing 
• 
Training needed to deploy the 
intervention? 
adult learners within higher education settings.  The researcher has 
a clinical background as a podiatrist and is currently registered with 
the HCPC.  
 
The researcher is the patient education lead within the department 
and is in the process of accrediting the DSME programme with 
QISMET.  
Intervention 
• 
How is the intervention different 
from normal care? 
• 
What does it look like? 
• 
Is it clear when it starts and 
finishes? 
Clinical intervention of participants will not be altered.  
 
Participants will receive the same DSME programme as routine 
clinical patients. Normal delivery of DSME programmes is by a 
diabetes specialist nurse or dietician. Research DSME programmes 
will be, where possible, delivered by the researcher for 
consistency.  
 
Participants will be reminded at the beginning of the DSME 
programme that this is a research study and that some participants 
will leave after 36 minutes, 3 hours and 36 minutes, with others 
remaining for the full 6 hours programme. Reminders will be given 
at the time points in which participants from groups 2 and 3 should 
leave.  
 
Contextual information 
• 
Policy initiatives related to the 
intervention? 
DSME is NICE recommended for all patients newly diagnosed with 
type 2 diabetes with annual refresher thereafter (15).  The National 
Diabetes Audit suggests 71% of people with type 2 diabetes are 
offered DSME, with an average attendance rate of 7%.   
 
Local records suggest that of those that start DSME (9%) only 12.6% 
complete the programme (20).  
 
Visit 3 
Between 3-4 months post intervention participants will be asked to repeat baseline psychometric tests.  For 
participants in group 4 this will be 4 months from enrolment. This will be the end of the study. 
At the end of the study participants in groups 2, 3 and 4 will be offered a full DSME programme.  
6.3 Data Collection 
A REDCap data capture template has been created for collection and analysis and included in Appendix 1.  
REDCap which provides a secure platform for clinical research studies (58,59) will be utilised for data capture. 
Screening and baseline demographics will be obtained from the patient electronic record system, if any 
demographic information is unavailable this will be collected direct from the participant. Paper questionnaires 
will be completed by hand by study participants supported by the researcher and subsequently entered on the 

 
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data capture sheet by the researcher (example data capture template in appendix 1). To ensure consistency of 
the data being collected DIABETES-PRO pathway checklists will be used for visits 1, 2 and 3 (appendix 1). 
6.4 Data Analysis 
Descriptive analysis will be completed for all demographic data presenting continuous variables as means ± 
standard deviation and categorical variables as numbers (%).  Data will be tested for normality using a Sharipo-
Wilk test and subject to visual inspection of histograms and normal Q-Q plots.  
Psychometric outcomes will include the Diabetes Self-Management Questionnaire-Revised (DSMQ-R)(48), 
Problem Areas in Diabetes (PAID) scale (49) and the Patient reported outcome measures information system 
(PROMIS) Global Health scale v1.2 (50).  Data will be treated as continuous and analysis of the difference in the 
mean before and after intervention will be conducted using an analysis of variance (ANOVA) test to check for 
statistical and clinical difference in the mean across the four groups.  
Statistical analysis will be conducted using IBM® SPSS® Premium 29 with support from University of Liverpool 
statisticians. The alpha level will be set at 5% for statistical significance.   
Whilst a statistically significant difference is desirable, it is important to understand what would represent a 
meaningful clinical change for a patient.  As such the minimal clinically important difference (MCID) will be 
reported to measure the smallest difference in which the patient would perceive a benefit (61–64).  Where the 
MCID is not published this will be calculated using a distribution-based derivation using 0.5 SD of the observed 
change in PROM score (62,65). Whilst this approach is not without its limitations (61,63) no consensus on the 
ideal means of determining the MCID is available (63).  A systematic review concluded that 0.5 SD of the observed 
change approximated the published MCID in the majority of cases popularising this derivation in the literature 
(65). 
MCID will be classed as >2 T-score points for the PROMIS Global Health v1.2 (66) in which physical health and 
mental health are given separate T-scores with a 95% confidence interval.  The MCID will be calculated for PAID 
and DSMQ-R. 
Recruitment of participants and the number of dropouts will be reported descriptively (frequencies and 
percentages).  Due to the aims of this study considering differing completion levels of DSME, intention to treat 
analysis will not be used. Where participants allocated to a group do not fully complete the required amount of 
DSME there results would be withdrawn from the final analysis. 
6.5 Data Storage 
All collected research data will be inputted by the researcher onto REDCap using a pseudo identifier and accessed 
via an NHS password protected encrypted computer.  All physical copies of consent forms, pathway checklists 
and completed questionnaires will be documented and filed securely in a locked filing cabinet on NHS property 
within one day of collection. Study pathway visit checklists (Appendix 1) and consent forms will contain 

 
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identifiable patient information labels (NHS number, name and date of birth) , these will only be used by the 
researcher and will not be shared.  Data will be given a unique study identifier at the point it is entered onto 
REDCap.   
All participants will be given a unique study identifier which will be recorded on the screening and recruitment 
log (appendix 1).  Patient identifier information will be kept in a separate, password protected database at the 
point of entry into the DIABETES-PRO study which will document a participants NHS number along with their 
unique study number. 
All data will be stored until data analysis is completed at which point it will be archived in line with Mersey and 
West Lancashire Teaching Hospitals NHS Trust R&D standard operating procedures (67) . Physical copies of data 
will be accessed on site (Diabetes Centre, St Helens Hospital) and destroyed when no longer required.  
STUDY SETTING 
This is a single-centre study.  All research activity including participant identification, recruitment, data collection 
and analysis will be conducted at the Diabetes Centre, St Helens Hospital, Marshalls Cross Road, WA9 3DA.  A 
representative convenience sample will be used of patients who have been referred to the Diabetes centre for 
support, education and / or advice with their type 2 diabetes or are highlighted via a shared care report as being 
newly diagnosed with type 2 diabetes in the last month by their primary care provider.   
Data will be stored at the Diabetes Centre until the point of data lock (completion of analysis) at which time it 
will be archived in line with Mersey and West Lancashire Teaching Hospitals NHS Trust R&D guidelines.  
SAMPLE AND RECRUITMENT PARTICIPANT ENTRY 
8.1 Eligibility Criteria 
8.1.1 Inclusion Criteria 
All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able 
to provide informed consent and are responsible for daily management of their diabetes will be screened for entry 
into the study.  
8.1.2 Exclusion Criteria 
The following patients will be excluded entry into the study: 
• 
Lack capacity to make an informed decision. 
• 
A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational 
diabetes. 

 
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• 
Received structured education for their diabetes within the last 12 months either online or face 
to face. 
• 
Require 1:1 education support e.g., requires interpreter. 
• 
Patients unable to attend for structured classroom education e.g., housebound. 
 
8.2 Recruitment 
8.2.1 Sample Size 
A sample size of 24-50 participants per group is deemed adequate within a feasibility study to estimate effect 
sizes and inform future DSME modifications and research (68,69).  A sample of 120 patients will be enrolled onto 
this study allowing for adequate numbers (n=30) across the four groups, controlling for expected participant 
drop out.  Monthly recruitment targets are pre-specified in a study progression criteria table (table 3) to ensure 
an adequate sample size is achieved for data analysis.  
The diabetes outpatient department receives a on average 24 referrals for DSME per month with a mean monthly 
attendance rate of 21 patients.  Locally an average of 86 patients are newly diagnosed with type 2 diabetes each 
month (20), patients who have opted in for data sharing are contacted with an offer of DSME.  This has been 
used to inform realistic recruitment rates.  Recruitment rates will be kept under review and discussed with 
supervisors should the monthly figure fall below projected numbers. 
Table 3:Progression criteria and study status 
Criterion 
Green 
Amber 
Red 
Monthly recruitment  
≥ 17 participants  
14-16 participants  
< 13 participants 
Retention rate 
>80% at endpoint 
60-80% at endpoint 
<60% at endpoint 
 
8.2.21.2.2 Sample identification and technique  
A convenience sample of 120 participants will be recruited for this study through three existing streams with 
potentially eligible participants added to the screening log sheet (appendix 1) and the pre-visit 1 section of the 
DIABETES-PRO study visit 1 pathway will be completed (appendix 1). 
1. Clinic lists of new patients due to attend the diabetes centre at St Helens Hospital are available on the 
hospital patient administration system.  The hospital electronic record will be used to screen for 
potentially eligible participants from the clinical list by the researcher.  Potentially eligible participants 
due to attend new patient clinic will be invited into the study by letter (appendix 1, NP clinic screening 
letter) with attached PIS which will be posted ahead of their clinical appointment. On the day of their 
clinical appointment the researcher will meet potentially eligible participants to check they received the 
PIS and to answer any questions. Where potentially eligible participants agree they will be invited for 

 
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screening. Following screening, where eligible participants agree to be involved in the research and 
provide written informed consent, they will be enrolled in the study. 
2. Patients who have been referred by their GP for DSME are called and offered education.  Education 
referrals will be used to screen for potentially eligible participants from those awaiting a DSME 
appointment by the researcher.  Potentially eligible participants will be asked as part of the DSME 
booking process if they would like information on the research. Where potential eligible participants 
agree a letter (appendix 1, telephone screening letter) will be sent out with a PIS and a screening 
appointment will be made with the researcher.  Screening appointments will be offered either at the 
Diabetes Centre or as a home visit.  Following screening, where eligible participants agree to be involved 
in the research and provide written informed consent, they will be enrolled in the study. 
3. Patients who have opted into data sharing and have been diagnosed with type 2 diabetes within the last 
month in primary care are reported via the shared care record, called and offered DSME.  As part of this 
process potentially eligible participants will be screened and identified by the researcher Potentially 
eligible participants will be asked as part of the DSME booking process if they would like information on 
the research. Where potential eligible participants agree a letter (appendix 1, telephone screening letter) 
will be sent out with a PIS and a screening appointment will be made with the researcher.  Screening 
appointments will be offered either at the Diabetes Centre or as a home visit.  Following screening, where 
eligible participants agree to be involved in the research and provide written informed consent, they will 
be enrolled in the study. 
The researcher is employed as a diabetes clinical research fellow in the Diabetes Centre at St Helens Hospital and 
therefore already a member of the patients existing clinical team, however, is not providing direct clinical care 
to any potential participants.  Clinical appointment lists and patient records will be obtained by the researcher 
in her existing NHS role.  Sampling will continue until the required number of participants are recruited. 
A screening and recruitment log will be stored in the study file and will include the following information: patient 
initials, screening outcome date of consent, if consent was refused, did/did not meet inclusion/exclusion criteria, 
date entered the study, unique identifier, randomisation group, study status (ongoing, withdrawn, completed, 
died) (70,71).  A blank copy of the screening and recruitment log is included in appendix 1. Mersey and West 
Lancashire Teaching Hospital NHS Trust R&D department will be informed of all participants recruited to the 
DIABETES-PRO study. 
8.2.3 Informed Consent 
The Participant Information Sheet (PIS) and Consent Form is the written information that explains the nature of 
the research, procedures involved and associated risks. Written informed consent will be obtained before any 
study specific procedures are undertaken. Informed consent is an ongoing process for all participants.  In 
obtaining and documenting informed consent, the researcher will comply with the applicable regulatory 
requirement(s) and adhere to Good Clinical Practice and to the ethical principles that have their origin in the 
Declaration of Helsinki. The European Commission Guidelines state that, 'subjects must be allowed sufficient 

 
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time to decide whether or not they wish to participate’. All PIS and consent forms will be identified by the date 
and version number.  
Where possible potentially eligible participants identified through new patient clinic lists will be sent a covering 
letter (NP clinic screening letter, appendix 1) and PIS ahead of their clinical appointment using an adapted 
template from the HRA website.  On arrival to clinic the researcher will greet the patient and ensure they have 
read and fully understood the information, answering any questions.   
For patients identified through GP education referrals or the shared care record database report for newly 
diagnosed type 2 diabetes, interested potentially eligible participants will be sent a letter (appendix 1, telephone 
screening letter) and a PIS ahead of the screening appointment with the researcher.  At the appointment with 
the researcher, either at the Diabetes Centre, or as a home visit, any questions will be answered.  
In those agreeing to take part in the research, written informed consent will be obtained and countersigned by 
the researcher.  Two copies will be made: one for the participant and one for scanning onto the patient electronic 
record by the R&D department with the research records retaining the wet ink version.  Consent forms (appendix 
1) have been designed using a template from the HRA website.  
Recruitment packs will be used which consists of exact copies of the PIS, Consent Form, and an Investigator 
Consent Process Checklist which will record the participants NHS number, name and date of birth.  Recruitment 
packs will be delivered to the research scanning collection point at the Cancer Research Team Office, St Helens 
Hospital within 24 hours (or the next working day) for scanning/recording purposes (70,71).  Occasionally, 
consent could be taken but the participant may not meet eligibility after screening procedures, this will be 
recorded in the study related screening and recruitment log. 
 
ADVERSE EVENTS 
9.1 Definitions 
Adverse Event (AE): any untoward medical occurrence in a patient or clinical study subject, including 
unfavourable and unintended signs, including abnormal laboratory results, symptoms or a disease associated 
with treatment. 
Serious Adverse Event (SAE): any untoward and unexpected medical occurrence or effect that: 
• 
Results in death 
• 
Is life‐threatening – refers to an event in which the subject was at risk of death at the time of the 
event; it does not refer to an event which hypothetically might have caused death if it were more severe 
• 
Requires hospitalisation, or prolongation of existing inpatients’ hospitalisation 
• 
Results in persistent or significant disability or incapacity 

 
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• 
Is a congenital anomaly or birth defect 
A risk assessment has been carried out for this study.  Risks are scored according to severity and likelihood 
giving an overall risk score (please see figure 5). Identified risks are detailed in table 4.  
Peer review feedback highlighted the risk of the researcher knowingly or unknowingly biasing results by 
supporting participants to complete the PROM tools. This has been risk assessed in table 5. To ensure 
transparency, support from the researcher will be limited to reading the questions verbatim for each of the 
PROM tools. This will be done for every participant to standardise the approach.   
9.2 Reporting procedures 
All adverse events will be reported. Depending on the nature of the event the reporting procedures below will 
be followed. Any questions concerning adverse event reporting should be directed to the Chief Investigator in 
the first instance. 
9.2.1 Non-serious Adverse Events (AEs) 
Potential Adverse Events (AEs) are outlined in table 5.  
All such events, whether expected or not, will be recorded on a Case Report Form (CRF) and in the 
patient's medical notes. 
9.2.2 Serious Adverse Events (SAEs) 
No serious adverse events are anticipated for this study. Upon identification of an SAE the researcher 
would complete a study specific SAE form which would be sent to the Chief Investigator within 24 
hours.  
Contact details for reporting SAEs 
Fax: +44(0)151 529 5888, attention Prof. John Wilding 
Please send SAE forms to: j.p.h.wilding@liverpool.ac.uk 
Tel: +44(0)151 529 5899 (Mon to Fri 09.00 – 17.00) 
All SAEs will be reported to the REC where in the opinion of the Chief Investigator, the event was: 
• 
‘related’, i.e. resulted from the administration of any of the research procedures; and 
• 
‘unexpected’, i.e. an event that is not listed in the protocol as an expected occurrence 
Reports of related and unexpected SAEs will be submitted within 15 days of the Chief Investigator 
becoming aware of the event, using the HRA Non-CTIMP safety report to REC form. The Chief Investigator 
will also notify the Sponsor of all SAEs. 
For NHS REC approved studies please refer to https://www.hra.nhs.uk/approvals-amendments/managing-your-
approval/safety-reporting/ - (Scroll to Safety reporting for non-CTIMP studies) 

 
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Figure 5: Risk assessment template and legend 
 
  
Impact Score 
  
Likelihood /probability 
1 
 
Rare 
2 
 
Unlikely 
3 
 
Possible 
4 
 
Likely 
5 
 
Almost certain 
5  Catastrophic  
5 
10 
15 
20 
25 
4  Major  
4 
8 
12 
16 
20 
3  Moderate  
3 
6 
9 
12 
15 
2  Minor  
2 
4 
6 
8 
10 
1  Negligible (very low) 
1 
2 
3 
4 
5 
Likelihood – Descriptor and definition 
Almost certain - More likely to occur than not, possibly daily (>50%) 
Likely - Likely to occur (21-50%) 
Possible - Reasonable chance of occurring, perhaps monthly (6-20%) 
Unlikely - Unlikely to occur, may occur annually (1-5%) 
Rare - Will only occur in exceptional circumstances, perhaps not for years (<1%) 
Impact - Descriptor and definition 
Catastrophic – Serious trust wide failure possibly resulting in patient deaths / Loss of registration status/ External enquiry/ Reputation of the organisation seriously damaged- National 
media / Actual disruption to service delivery/ Removal of Board 
Major – Significant negative change in Trust performance / Significant  deterioration in financial position/ Serious reputation concerns / Potential disruption to service 
delivery/Conditional changes to registration status/ may be trust wide or restricted to one service  
Moderate – Moderate change in Trust performance/ financial standing affected/ reputational damage likely to cause on-going concern/potential change in registration status 
Minor – Small or short term performance issue/ no effect of registration status/ no persistent media interest/ transient and or slight reputational concern/little financial impact. 
Negligible (very low) – No impact on Trust performance/ No financial impact/ No patient harm/ little or no media interest/ No lasting reputational damage. 

 
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Table 4: Potential participant adverse study events and controls. 
 
Risk 
Initial 
Risk 
Score
Key Controls 
Sources of Assurance 
Residual 
Risk 
Score 
(
)
Additional 
Controls 
Required 
Additional 
Assurance 
Required 
Action Plan 
(with target 
completion 
dates) 
Target 
Risk 
Score 
Participants  become 
distressed after 
completing patient 
reported outcome 
measures highlighting 
diabetes distress 
3 x 1 
The use of PROMs selected for use within this study are 
validated tools approved for use in clinical practice however it 
may be possible that a participant becomes distressed if a 
score is not anticipated e.g., diabetes distress highlighted. 
Where participants are highlighted as having high levels of 
distress then a letter will be sent to their GP with their 
permission highlighting further support may be needed.  
Participants will also be given contact details for St Helens 
Think Well-Being team.  
Validated PROMs designed 
for use measuring diabetes 
distress, quality of life and 
self-care abilities which have 
been used and designed in 
collaboration with people 
with diabetes. Psychological 
support pathway already in 
place locally.   
3 x 1 
None 
needed 
None needed 
Progress as 
planned 
3 x 1 
As a result of delayed 
or incomplete DSME 
participants are 
unable to adequately 
manage their 
diabetes  
4 x 2 
There is a national NICE recommended target to offer all 
patients DSME within 12 months of diagnosis. This study will 
potentially delay DSME access by 4 months, less than the 
nationally recommended 12 months. All participants will be 
offered a full DSME programme at the end of the study. As a 
result of participating in this study participants are likely to gain 
access to DSME sessions quicker than those on the routine 
waiting list. 
DSME offers and attendance 
are recorded locally and are 
reported nationally via the 
National Diabetes Audit.  
Database will be monitored 
weekly to ensure no 
unnecessary delay in 
offering DSME programmes 
following completion of the 
research.   
3 x 1 
None 
needed 
None needed 
Progress as 
planned 
3 x 1 
As a result of the 
DSME programme 
participants worry 
about the impact of 
diabetes on their 
long-term health 
2 x 1 
DSME sessions are taught by health care professionals with 
experience working with people with diabetes and will be able 
to offer any advice and reassurance as required. As part of the 
DSME programme all participants will receive a short booklet 
about managing their diabetes at the start of the programme.  
Education sessions will be 
QISMET accredited and are 
designed to support 
behavioural changes with 
patients. Information about 
the seriousness of diabetes 
is delivered sensitively to by 
trained health care 
professionals with 
experience in teaching. 
2 x 1 
None 
needed 
None required 
Progress as 
planned 
2 x 1 
Participants are 
concerned about how 
their data will be 
used and if they will 
be identifiable 
3 x 3 
Participants will be reassured as part of the screening and 
recruitment process about how data is handled and that a 
pseudocode will be used at the point their data is entered onto 
the study database. Only the researcher will have access to the 
cross-identifier checklist.  Participants will be reminded that 
they are free to withdraw from the study at any point at which 
no further data about them will be collected.  
Participant information 
sheet, consent form and 
data management plan. 
2 x 1 
None 
needed 
None needed 
Progress as 
planned 
2 x 1 

 
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Table 5: Potential researcher bias risk assessment and controls. 
Risk 
Initial 
risk 
score 
Key controls 
Residual 
risk 
score 
Additional 
controls 
required 
Additional 
assurance 
required 
Action plan Target risk 
score 
Researcher 
knowingly or 
unknowingly 
influences 
participants 
understanding 
of questions in 
an effort to 
support 
completion of 
item.  
2 x 2 
Researcher 
support will be 
limited to  
reading tool 
questions 
verbatim. 
1 x 2 
None 
needed 
None 
needed 
Progress as 
planned 
1 x 2 
 
10. REGULATORY ISSUES 
10.1 Ethical Approval 
Before the start of the study, a favourable opinion will be sought from the UK Health Department’s Research 
Ethics Service NHS REC for the study protocol, informed consent forms and other relevant documents e.g. patient 
letters, consent forms and PIS.  Health Research Authority (HRA) approval will be obtained where required. 
The study will be submitted for Confirmation of Capacity and Capability. The study will be conducted in 
accordance with the recommendations for physicians involved in research on human subjects adopted by the 
18th World Medical Assembly, Helsinki 1964 and later revisions.  Prior to the recruitment of any participants the 
Chief Investigator or designee will ensure that appropriate approvals are in place.  
The researcher will work with Mersey and West Lancashire Teaching Hospitals NHS Trust research and 
development team throughout the process to implement and confirm their support for the study as required.  
10.2 Confidentiality 
The Chief Investigator will preserve the confidentiality of participants taking part in the study and will abide by the Data 
Protection Act 2018 and the UK GDPR as amended from time to time and any successor legislation in the UK and any 
other directly applicable regulation relating to data protection and privacy. 
As discussed in section 6.5 all collected research data will be kept on an NHS password-protected encrypted computer. 
All physical copies of consent forms and completed questionnaires will be documented and filed securely in a locked 
filing cabinet on NHS property within one day of collection. All participants will be given a unique study identifier, and 
patient identifier information will be kept in a separate, password protected database at the point of entry into the 
study.  Where data do need to be transferred between the researcher and supervisory team this will be via secure NHS-
encrypted email or with a secure NHS encrypted USB drive.  

 
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All data will be stored until data analysis is completed at which point it will be archived in line with Mersey and West 
Lancashire Teaching Hospitals NHS Trust R&D protocols (67).  Physical copies of data will be accessed on site (Diabetes 
Centre, St Helens Hospital) and destroyed when no longer required. 
10.3 Indemnity 
The University of Liverpool holds Indemnity and insurance cover with Newline Insurance Company, which apply 
to this study. 
10.4 Audits 
The study may be subject to inspection and audit by the University of Liverpool under their remit as sponsor and 
other regulatory bodies to ensure adherence to GCP and the UK Policy Framework for Health and Social Care 
Research (v3.2 10th October 2017). 
10.5 Document Control 
Any amendments to the study will be with agreement with the Chief Investigator and the researcher’s 
supervisory team.  Amendments to the protocol or associated study documents will be the responsibility of the 
researcher with advice and support from the supervisory team who will collectively agree if amendments are 
substantial or non-substantial and require re-submission to the REC. All amendments will be tracked and filed in 
the following fashion: ‘study title’ – ‘document name’ – ‘document version number’ – ‘document creation / 
update date’.  
Document version numbers are displayed as 'Major.Minor.Revision'.  The first version of a document would be 
'1.0.0' with revisions displayed as '1.0.1', minor adaptations as '1.1.0' and major changes as '2.0.0'.  Once updated 
documents have been ratified, old copies of the documents will be archived, and the new copies will replace 
them in the master file.  Document revisions will be recorded in a separate document.  
11. END OF STUDY 
End of study will be classified as the end of data analysis at which point an end of study declaration will be 
submitted.  Once the end of study is declared no study activity, other than final analysis of the data (following 
‘lock’ of the study database) and report writing, will be undertaken.  End of study will be declared to the research 
ethics committee as per University of Liverpool standard operating procedures(72).  
12. DISSEMINIATION POLICY 
12.1 Dissemination policy 
Upon completion of the study the study data will be analysed and tabulated with findings and discussions that form 
as part of the analysis forming part of the researcher’s PhD thesis. Publications, posters, and abstracts are planned 
as part of this process within suitable journals and professional national and international conferences. Following 
completion and publication of the research the data will be owned by University of Liverpool and will be made 

 
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available via the research data repository upon completion of the PhD.  Participants will be sent an end of study 
summary after the final study report has been completed. 
13. ARCHIVING 
The University of Liverpool Information Management Policy (73), Records Retention Guide (74)and Records 
Retention Schedule Version CSD 3.0 (75) have guided decisions on data retention and disposal for this project. 
Archiving practices will follow processes of the sponsor (University of Liverpool), whereby the study master file 
which includes findings and output data will be kept in an appropriate format and storage for at least 10 years.  
Personal addresses, postcodes and telephone numbers of all potential participants will be in a password 
secured database on an NHS desktop computer and on the secure NHS trust server.  They will ensure 
compliance with the legal requirements of the GDPR and the Caldicott principles adopted by the NHS.  Paper 
data collection forms will be kept in a secure locked location at the study site.  Consent forms will be retained 
as essential documents, but items such as contact details will be deleted as soon as they are no longer 
required.   
All metadata records for the qualitative data will be uploaded onto the University research data repository.  All 
records will be anonymised and identified by study number only in order to maintain confidentiality.  The PI will 
have access to this data.   
 
 

 
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15. Appendices 
 Provided as separate documents at request of sponsorship team. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
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15.2 
Appendix 2 – Amendment History 
Amendment 
No. 
Protocol 
version no. 
Date issued 
Author(s) of 
changes 
Details of changes made 
1 
V1.0.1 
31.1.24 
Gemma Lewis 
• 
The criteria ‘Dementia’ has been 
removed and will now be encompassed in 
the exclusion criteria of those who are 
unable to make an informed decision, 
allowing those who are able to provide 
informed consent ability to participate. 
• 
A second exclusion criterion states 
“Severe or enduring mental health 
problem which prevent group education 
attendance.” This has been removed and 
will be encompassed within the exclusion 
criteria amended ‘Patients unable to 
attend for structured classroom 
education’. 
• 
The Archiving section has been 
completed and guidance text removed 
• 
The End of Study definition states 
the Trust SOP will be followed but this 
should be the Sponsor SOP. This has been 
updated. 
2 
V1.0.2 
07.02.24 
Gemma Lewis 
Section 13, Archiving revised following 
sponsor feedback and encompass The 
University of Liverpool Information 
Management Policy, Records Retention 
Guide and Records Retention Schedule 
Version CSD 3.0. Table included to give 
greater clarity.  
3 
V1.0.3 
19.2.24 
Gemma Lewis 
Section 13 Archiving updated as per 
sponsor requirements.  
4 
V1.1.0 
27.03.24 
Gemma Lewis 
Section 6.4 Data Analysis updated 
following REC feedback. Information 
included clarifies how dropouts will be 
managed within analysis of data. 
 
List details of all protocol amendments here whenever a new version of the protocol is produced. 

 
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Protocol amendments must be submitted to the Sponsor for approval prior to submission to the REC.