Type 2 Diabetes: Risk Perceptions and Self-management Behaviour
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Sponsor: University of Oxford

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 1 of 15 
Study Title: Type-2 diabetes: risk perceptions and self-management behaviour. 
 
 
Ethics Ref: 
 
Date and Version No: 7 April 17 – Version No 1.0 
 
Chief Investigator: 
Thomas Rouyard 
DPhil student 
HERC, Nuffield Department of Population Health 
Old Road Campus 
Headington, Oxford, OX3 7LF 
e: thomas.rouyard@gtc.ox.ac.uk | t: 01865 289221 
 
Investigators:  
Pr Alastair Gray 
HERC, Nuffield Department of Population Health 
Old Road Campus 
Headington, Oxford, OX3 7LF 
e: alastair.gray@ndph.ox.ac.uk | t: 01865 289279 
 
Dr Jose Leal 
HERC, Nuffield Department of Population Health 
Old Road Campus 
Headington, Oxford, OX3 7LF 
e: jose.leal@ndph.ox.ac.uk | t: 01865 289263 
 
Dr Richard Baskerville 
27 Beaumont St Practice 
Oxford, OX1 2NR 
e: richard.baskerville@nhs.net | t: 01865 311500 
 
Sponsor:  
University of Oxford 
 
Funder: 
The research is supported by the University of Oxford (‘Oxford-Health 
Economics Research Centre Graduate Scholarship’). 
 
Chief Investigator Signature:  
X
Thomas Rouyard
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 2 of 15 
Conflicts of interest: None. 
 
 
Confidentiality Statement 
This document contains confidential information that must not be disclosed to anyone other than the 
Sponsor, the Investigator Team, host organisation, and members of the Research Ethics Committee, unless 
authorised to do so. 
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 3 of 15 
TABLE OF CONTENTS 
 
1. 
SYNOPSIS ............................................................................................................................................... 5 
2. 
ABBREVIATIONS ..................................................................................................................................... 5 
3. 
BACKGROUND AND RATIONALE ............................................................................................................ 5 
4. 
OBJECTIVES AND OUTCOME MEASURES ............................................................................................... 6 
5. 
STUDY DESIGN ....................................................................................................................................... 7 
6. 
PARTICIPANT IDENTIFICATION .............................................................................................................. 7 
6.1. 
Study Participants .......................................................................................................................... 7 
6.2. 
Inclusion Criteria ............................................................................................................................ 7 
6.3. 
Exclusion Criteria ........................................................................................................................... 7 
7. 
STUDY PROCEDURES ............................................................................................................................. 7 
7.1. 
Recruitment ................................................................................................................................... 7 
7.1. 
Screening and Eligibility Assessment ............................................................................................. 8 
7.2. 
Informed Consent .......................................................................................................................... 8 
7.3. 
Procedure ...................................................................................................................................... 8 
7.4. 
Intervention ................................................................................................................................... 9 
7.5. 
Intervention Effects ....................................................................................................................... 9 
7.6. 
Discontinuation/Withdrawal of Participants from Study .............................................................. 9 
7.7. 
Definition of End of Study ............................................................................................................. 9 
8. 
STATISTICS AND ANALYSIS ..................................................................................................................... 9 
8.1. 
Description of Statistical Methods ................................................................................................ 9 
8.2. 
The Number of Participants ........................................................................................................ 10 
8.3. 
Analysis of Outcome Measures ................................................................................................... 10 
9. 
DATA MANAGEMENT .......................................................................................................................... 10 
9.1. 
Access to Data ............................................................................................................................. 10 
9.2. 
Data Recording and Record Keeping ........................................................................................... 10 
10. QUALITY ASSURANCE PROCEDURES ................................................................................................... 11 
11. ETHICAL AND REGULATORY CONSIDERATIONS ................................................................................... 11 
11.1. 
Declaration of Helsinki............................................................................................................. 11 
11.2. 
Guidelines for Good Clinical Practice ...................................................................................... 11 
11.3. 
Approvals ................................................................................................................................. 11 
11.4. 
Reporting ................................................................................................................................. 11 
11.5. 
Participant Confidentiality ....................................................................................................... 11 
11.6. 
Expenses and Benefits ............................................................................................................. 12 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 4 of 15 
11.7. 
Other Ethical Considerations ................................................................................................... 12 
12. FINANCE AND INSURANCE .................................................................................................................. 12 
12.1. 
Funding .................................................................................................................................... 12 
12.2. 
Insurance ................................................................................................................................. 12 
13. PUBLICATION POLICY ........................................................................................................................... 12 
14. REFERENCES ........................................................................................................................................ 13 
 
 
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 5 of 15 
1. SYNOPSIS 
 
Study Title 
Type-2 diabetes: risk perceptions and self-management behaviour 
Internal ref. no. / short 
title 
 
Study Design 
Pilot study, Questionnaires 
Study Participants 
People with Type 2 diabetes, aged 30 to 75 
Planned Sample Size 
40  
Planned Study Period 
01/06/2017 – 01/10/2017 
 
Objectives 
Outcome Measures 
Primary 
 
To assess the feasibility of a larger 
study. 
Feasibility 
of 
study 
protocol, 
consent 
rate, 
acceptability 
of 
intervention, retention rate, rates 
of missing data. 
Secondary 
 
To assess the effectiveness of the 
intervention in patient’s awareness of 
risks for complications associated with 
Type 2 diabetes.  
Change in risk perception scores.  
To assess whether the intervention 
encourages 
the 
adoption 
of 
recommended self-care behaviours.  
Change 
in 
self-management 
behaviour scores. 
 
2. ABBREVIATIONS 
 
CI 
Chief Investigator 
CRF 
Case Report Form 
CTRG 
Clinical Trials & Research Governance, University of Oxford 
GCP 
Good Clinical Practice 
GP 
General Practitioner 
NHS 
National Health Service 
REC 
Research Ethics Committee 
T2DM 
Type-2 Diabetes Mellitus 
 
3. BACKGROUND AND RATIONALE 
 
For the past twenty years, evidence has accumulated about the harmful effects caused by type 2 diabetes. 
Overall, people with type-2 diabetes (T2DM) have age-specific death rates about twice those of the general 
population. In particular, they have a higher risk of experiencing cardiovascular diseases. 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 6 of 15 
 
In the recent literature, there is a consensus that consistent self-management behaviour can delay the 
onset of complications associated with type 2 diabetes. Several studies have shown that diabetes self-
management education - i.e. interventions aiming at improving (multidimensional) self-management in 
patients – are associated with improved intermediate outcomes (especially glycaemic control) and thus, 
indirectly, clinical outcomes. [1-6] This might explain why self-management has become the cornerstone 
for treating T2DM. [7, 8] However, in spite of this consensus, the most effective method to provide 
diabetes self-management education (SME) is still unclear. 
 
Although many factors are known to influence health behaviours, risk perceptions are thought to play a 
key role in the behavioural process. People who underestimate their risks may be less likely to adopt 
recommended behaviours, while overestimating their risks may cause so much anxiety that it hampers 
people from taking precautionary measures [9]. There is strong evidence supporting the causality of the 
association between perceived risks and precautionary behaviours; empirical data have shown a highly 
significant, albeit small-to-moderate, positive association [10-12]. In addition, perceived risks are 
significant predictors of behavioural intentions [13, 14]. Although behavioural processes are complex, 
wrong risk perceptions are a major impediment to the adoption of self-care behaviours and, as a result, 
an additional risk for the occurrence of adverse outcomes. 
 
Recent studies have shown that people with T2DM largely underestimate their risks of developing 
complications. [15] Existing risk communication interventions have shown mixed results, with many 
participants barely understanding the explanations of health professionals about risks and having poor 
recall of risk information [16-18]. In this context, there is a need for better risk communication 
interventions. [15] Rather than increasing the quantity of information to be communicated (‘less is often 
more’ [19]), it is necessary to improve its quality. New interventions that make use of patients’ decision-
making biases are considered to be very promising in the risk communication ﬁeld [20-22]. We believe that 
such interventions, through which personalised risks are communicated, will help to correct erroneous risk 
perceptions, and, in turn, have a greater impact on self-care behaviours.   
 
Based on the results of recent studies investigating the risk perceptions and risk attitudes of people with 
T2DM, we have developed a new, tailored risk communication intervention. This intervention aims to 
increase patients’ awareness of their risks for complications associated with T2DM and, in turn, to 
encourage the adoption of recommended self-care behaviours. The objectives of the full trial are to assess 
the feasibility and measure the expected impact of such an intervention, in order to inform the design of 
a larger study (RCT to be conducted in the future). 
 
4. OBJECTIVES AND OUTCOME MEASURES 
 
Objectives 
Outcome Measures  
Timepoint(s) of evaluation of this 
outcome measure (if applicable) 
To assess the feasibility of a 
larger study. 
Feasibility of study protocol, 
consent rate, acceptability of 
After the study. 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 7 of 15 
intervention, 
retention 
rate, 
rates of missing data. 
To assess the effectiveness 
of the intervention in patient’s 
awareness 
of 
risks 
for 
complications associated with 
Type 2 diabetes.  
Change in risk perception scores.  • Baseline 
(right 
before 
the 
intervention). 
• Baseline 
(right 
after 
the 
intervention). 
• After 12 weeks. 
To 
assess 
whether 
the 
intervention encourages the 
adoption of recommended 
self-care behaviours.  
Change 
in 
self-management 
behaviour scores. 
• Baseline 
(right 
before 
the 
intervention). 
• After 12 weeks. 
 
 
5. STUDY DESIGN 
 
We have designed a pilot study to assess the feasibility and measure the impact of a risk communication 
intervention for people with T2DM on risk perceptions and self-management behaviour. The intervention 
has been developed in collaboration with both health professionals and patients. 
 
6. PARTICIPANT IDENTIFICATION 
6.1. Study Participants 
40 participants will be recruited (20 in the intervention group, 20 in the control group). 
 
6.2. Inclusion Criteria 
 
• Participant is willing and able to give informed consent for participation in the study. 
• Aged between 30 and 75. 
• Diagnosed with Type-2 diabetes. 
 
The rationale for the lower age limit (30) is that the disease is rarely diagnosed before that age. The 
rationale for the upper age limit (75) is to be in line with similar existing studies. 
 
6.3. Exclusion Criteria 
• If unable to provide informed consent. 
• If non-English speaker. 
• If not suitable for the study according to GP. 
 
7. STUDY PROCEDURES 
7.1. Recruitment 
Potential participants will be identified by their GP at 27 Beaumont St practice, Oxford.  
 
Patients willing to participate in the study will be notified during their regular clinical appointments and 
research visits will be set up to coincide with patients’ appointments. 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 8 of 15 
 
7.1. Screening and Eligibility Assessment 
The GP will screen his records in order to identify eligible patients. 
 
7.2. Informed Consent 
A patient information sheet; detailing no less than the exact nature of the study, what it will involve for 
the participant, the implications and constraints of the protocol, and any risks in taking part; will be given 
to eligible patients during their regular clinical appointment. It will be clearly stated that the study is 
optional and that the participant is free to withdraw without a reason at any time without prejudice to 
future care or affecting their rights. The GP will also explain the study and answer potential questions. 
 
Patients willing to participate in the study after reading the patient information sheet will let their GP know 
and research visits will be set up to coincide with the patients’ next appointments, approximately 6 weeks 
after approach. The CI will meet with the patient to discuss the study, answer any questions they have and 
receive written informed consent, in the form of a participant dated signature and the dated signature of 
the CI, to take part.  
 
7.3. Procedure 
 
• Visit 1 
For participants who gave their informed consent, the CI will administer the study questionnaires that 
measures risk perceptions and assesses self-management behaviour (~10 minutes). [23, 33] 
 
After the first set of questionnaires are completed, all participants will attend their routine clinical 
consultation with their GP. During the consultation, half of the participants will receive the risk 
communication intervention from the GP (intervention group, ~5 minutes) and half of the participants will 
not (control group). Participants will be randomised into the intervention or the control group by means 
of a list drawn up by a computerised randomisation program. They will be attributed with an order number 
and this number will be randomly allocated into one of the two groups. The participant will be blind to 
their allocation but the CI will not be.  
 
Right after the consultation, risk perceptions of all participants (i.e. in both groups) will be measured by 
the CI once again (~5 minutes), to account for potential effect of the consultation on the control group. 
 
• Visit 2 
At participants’ next consultation visit, which will be approximately 12 weeks after the intervention, the 
same questions about risk perceptions and self-management behaviour will be asked by the CI right before 
the consultation (~10 minutes). 
 
The interest of face-to-face appointments is that it ensures reliability in participants’ answers, as compared 
to email or telephone interviews. 
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 9 of 15 
This methodology has been used in most recent studies that aimed at measuring the impact of risk 
communication interventions. [17, 24, 25] 
 
7.4. Intervention 
 
The GP will discuss participants’ personalised risk estimates for diabetes-related complications and life 
expectancies associated with different self-management behaviours (~5 minutes). These personalised risk 
estimates will be calculated by the GP through a validated simulation model (UKPDS-OM [32]). According 
to personal characteristics (age, gender, ethnicity…) and risk factors (duration of diabetes, history of 
complications, blood glucose level…), the UKPDS-OM allows to compute, for each individual, their own 
(personalised) risk estimates of developing diabetes-related complications and life expectancies. 
 
7.5. Intervention Effects 
In the unlikely event of a negative effect of the intervention on risk perceptions and/or self-management 
behaviour found after data analysis, the CI will inform the GP. Personal details of participants will be kept 
separate from research data, and the CI will use ID numbers to refer to a given participant. The use of ID 
numbers will be limited for the purpose of giving feedback to the GP after data analysis. 
In case a positive effect on risk perceptions and self-management behaviour is found in the intervention 
group, the intervention will also be offered to participants in the control group at their next consultation 
visit. 
 
7.6. Discontinuation/Withdrawal of Participants from Study 
Each participant has the right to withdraw from the study at any time.  In addition, the Investigator may 
discontinue a participant from the study at any time if the Investigator considers it necessary for any 
reason including withdrawal of consent. Data collected up to the withdrawal will be used. 
 
7.7. Definition of End of Study 
The end of study is the date when the questionnaire of the last participant will have been filled out. 
 
8. STATISTICS AND ANALYSIS 
8.1. Description of Statistical Methods 
Frequencies and percentages will be used to describe categorical variables, and means ± SD to describe 
continuous variables. 
 
Pre-post intervention differences between groups in terms of study outcome variables will be tested using 
Chi-square and Student t-tests, whereas pre-post intervention differences within groups will be tested 
using McNemar and paired t-tests. 
 
The Kappa test will be used for detecting the degree of agreement between pre- and post-perceived risk 
with baseline objective risk. 
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 10 of 15 
In the intervention group, correlation between appropriateness of risk perceptions and self-management 
scores (post-intervention) will be tested by means of point biserial correlation. Finally, Pearson and 
Spearman correlations will be used to test for correlations between observable characteristics and 
outcome variables. 
 
8.2. The Number of Participants 
40 participants will be recruited (20 in the intervention group, 20 in the control group). 
 
According to Connelly (2008), extant literature suggests that a pilot study sample should be 10% of the 
sample projected for the larger parent study. [26] Isaac and Michael (1995) suggested 10 - 30 participants 
[27]; Hill (1998) suggested 10 to 30 participants for pilots in survey research [28]; Julious (2005) in the 
medical field [29] and van Belle (2002) suggested 12 [30]; Treece and Treece (1982) suggested 10% of the 
project sample size. [31] 
 
Existing studies of reference used the following sample sizes: 
Welschen et al (2012) [17]: 261 
Asimakopoulou et et al (2008) [24]: 95 
Tawfik & Mohamed (2016) [25]: 180 
 
Based on these observations, we decided to take the size of the bigger sample as reference (n=261) and 
to apply the 10% rule. However, in order to allow for drop-outs and facilitate comparison between the two 
arms, we decided to add a margin and target 40 participants in total. 
 
8.3. Analysis of Outcome Measures 
We will analyse the following outcome variables: 
- 
Feasibility of a larger study: in order to inform the design of a larger study, we will assess the 
following criteria: integrity of study protocol, consent rate, acceptability of intervention, expected 
impact of intervention. 
- 
Appropriateness of risk perceptions: we will compare participants’ perceived risks to their 
personalised risk estimates computed via a validated simulation model (UKPDS-OM [32]). 
- 
Self-management scores: we will assess participants’ adherence to self-care activities using two 
validated questionnaires: 1) The Summary of Diabetes Self-Care Activities Measure (SDSCA) [23]; 
2) The 8-Item Morisky Medication Adherence Scale (MMAS-8) [33] 
 
9. DATA MANAGEMENT 
9.1. Access to Data 
Direct access will be granted to authorised representatives from the Sponsor and host institution for 
monitoring and/or audit of the study to ensure compliance with regulations. 
 
9.2. Data Recording and Record Keeping 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 11 of 15 
Data will be anonymised and no participant will be identifiable from the data in the possession of the 
researchers, outside of the CI and the direct care team. Participants will be linked to an ID number that 
will be used by the CI to give feedback to the GP after study. 
 
Anonymised research data will be recorded and stored numerically (University password-protected 
computers), managed by Thomas Rouyard, for the duration of the project. Only the researchers involved 
in the project will have access to the data. Data may be kept up to 5 years following the publication of 
research findings in University locked up cupboards. Data may also be used to inform the design of a larger 
trial before publication of research findings and be included in the analysis of this larger trial. 
 
10. QUALITY ASSURANCE PROCEDURES 
The study may be monitored, or audited in accordance with the current approved protocol, GCP, relevant 
regulations and standard operating procedures. 
 
The CI administering the questionnaires will continually be present with the participants, which will ensure 
reliable, high quality data to be collected. 
 
11. ETHICAL AND REGULATORY CONSIDERATIONS 
11.1. 
Declaration of Helsinki 
The Investigator will ensure that this study is conducted in accordance with the principles of the 
Declaration of Helsinki. 
 
11.2. 
Guidelines for Good Clinical Practice 
The Investigator will ensure that this study is conducted in accordance with relevant regulations and with 
Good Clinical Practice. 
 
11.3. 
Approvals 
The protocol and participant information sheet will be submitted to an appropriate Research Ethics 
Committee (REC), HRA, and host institution(s) for written approval. 
 
The Investigator will submit and, where necessary, obtain approval from the above parties for all 
substantial amendments to the original approved documents. 
 
11.4. 
Reporting 
The CI shall submit once a year throughout the study, or on request, an Annual Progress report to the REC 
Committee, host organisation and Sponsor.  In addition, an End of Study notification and final report will 
be submitted to the same parties. 
 
11.5. 
Participant Confidentiality 
The study staff will ensure that the participants’ anonymity is maintained.  The participants will be 
identified only by a participant ID number on all study documents and any electronic database, with the 
exception of the CRF, where participant initials may be added.  All documents will be stored securely and 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 12 of 15 
only accessible by study staff and authorised personnel. The study will comply with the Data Protection 
Act, which requires data to be anonymised as soon as it is practical to do so. 
 
11.6. 
Expenses and Benefits 
Each participant will receive £10 for their time taking part in the study, upon completion of the last 
questionnaire (visit 2). This has been determined on the basis of previous studies published in the 
literature. 
11.7. 
Other Ethical Considerations 
The intervention has been developed in collaboration with both health professionals and patients. 
Although some patients might find risk communication distressing, the intervention has been designed to 
be as patient-friendly as possible and will be conducted by patients’ personal GP. Patients will be 
encouraged to share any concern with their GP. 
 
12. FINANCE AND INSURANCE 
12.1. 
Funding 
The research is supported by the University of Oxford (‘Oxford-Health Economics Research Centre 
Graduate Scholarship’). 
 
12.2. 
Insurance 
The University has a specialist insurance policy in place which would operate in the event of any participant 
suffering harm as a result of their involvement in the research (Newline Underwriting Management Ltd, at 
Lloyd’s of London).  NHS indemnity operates in respect of the clinical treatment that is provided. 
 
13. PUBLICATION POLICY 
The Investigators will be involved in reviewing drafts of the manuscripts, abstracts, press releases and any 
other publications arising from the study. Authors will acknowledge that the study was funded by the 
National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and 
Care Oxford at Oxford Health NHS Foundation Trust. Authorship will be determined in accordance with 
the ICMJE guidelines and other contributors will be acknowledged. 
 
 
Amendment table 
Amendment number 
Protocol number 
Date 
Author 
Description 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 13 of 15 
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2. Gary, T. L., J. M. Genkinger, E. Guallar, M. Peyrot and F. L. Brancati (2003). "Meta-analysis of randomized 
educational and behavioral interventions in type 2 diabetes." The Diabetes Educator 29(3): 488-501. 
 
3. Norris, S. L., M. M. Engelgau and K. V. Narayan (2001). "Effectiveness of self-management training in 
type 2 diabetes: a systematic review of randomized controlled trials." Diabetes care 24(3): 561-587. 
 
4. Norris, S. L., J. Lau, S. J. Smith, C. H. Schmid and M. M. Engelgau (2002). "Self-Management education 
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Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
Page 14 of 15 
 
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Research Protocol _ version 1.0 
 
                        7 April 2017 
Type-2 diabetes: risk perceptions and self-management behaviour 
 
 
Thomas Rouyard 
IRAS project ID: 210623 
 
 
 
Clinical Research Protocol Template version 11.0      
 
 
 
 
CONFIDENTIAL 
© Copyright: The University of Oxford and Oxford University Hospitals NHS Trust 2016  
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