SHARE-D: a Decision Tool to Help Patients With, or at Risk of, Coronary Heart Disease Make Informed Lifestyle Choices: Feasibility Study
Phase: NA
Conditions: Health Behavior
Sponsor: Queen's University, Belfast

Page 1 of 4 
 
 
 
 
 
 
 
 
 
 
 
SHARE-D: a Decision Tool to Help Patients  
Make Informed Lifestyle Choices 
 
 
 
                                                NCT03276546 
 
 
 
 
 
 
 
 
 
 
07 March 2016 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

Page 2 of 4 
 
Purpose and relevance 
This project will inform development of a definitive shared decision tool and methods for its use in 
practice (eg. mobile application, with/without health professional). Further, it will be sustainable beyond 
the grant’s lifetime as it will inform the design of a RCT and increase awareness of peoples’ needs and 
resources in supporting lifestyle change. 
 
To our knowledge the tool which we propose to test, is novel. It is paper-based in its current format, 
designed to be carried out in consultation with a health professional, focuses on PA and diet, and 
considers individuals’ personal circumstances. Our tool (‘SHARE-D’) aims to help people consider why 
and how they may change their lifestyles by guiding their decisions and taking account of their personal 
circumstances. Good decision-making, identifying the means of developing habits and routines, is the 
first step in the process of sustaining long-term change and healthy lifestyles. A novel instrument, 
targeting individuals with, and at risk of, chronic disease, to improve their decision-making through 
shared decision-making interventions thus has the potential to improve public health measurably. 
 
Study aims and objectives 
This feasibility study aims to examine the use of a questionnaire tool (‘SHARE-D’) for shared decision-
making in primary care practice for patients with, and at high risk of, coronary heart disease (CHD), 
using both quantitative and qualitative methods. The project has six key objectives:  
 
1. To test the feasibility of using a novel shared decision tool for diet and PA behaviour change, for 
patients in primary care. 
2. To assess participants’ diet and physical activity behaviour by administering the Dietary Instrument for 
Nutrition Education (DINE) questionnaire and Recent Physical Activity Questionnaire (RPAQ). 
3. To make an objective assessment of participants’ level of PA by using an accelerometer. 
4. To explore patients’ views regarding the usefulness and acceptability of the decision tool. 
5. To explore practitioners’ views of the decision tool. 
6. To refine the design of a decision tool, for shared decision-making and for use in clinical practice, to 
facilitate initiation of sustained behaviour change. 
 
Methods 
Selection of practices 
We propose to invite five general practices in Northern Ireland (NI) to participate, one from each of the 
five regional Health and Social Care Trusts. Practices will be selected purposively to include a range of 
geographical locations (rural/urban, with varying levels of socio-economic deprivation and social 
contexts) and practice size. With the assistance of the NI Clinical Research Network (Primary Care), we 
will telephone a key staff member in each of the selected practices to explain what the proposed study is 
about and explore their interest in participating. For those who express interest, we will post study 
information to the practice, allowing them time to discuss the study and decide whether to take part or if 
more information is needed. With their agreement, the researcher will arrange a suitable time to visit the 
practice and explain further the planned protocol. If an invited practice declines to participate we will 
identify a further practice with a similar profile for invitation to ensure that 5 practices participate. 
 
Selection of patients 
We propose to ask GPs to identify eligible patients (see criteria below) from their medical records or 
opportunistically and invite participation from people with a range of ages (18 years and above), different 
genders and, for those with established CHD, a range of time since diagnosis. We will ask GPs to 
identify 12 patients in each practice for invitation to take part in the study and to exclude from invitation 
patients whom they deem are physically or mentally unable to answer the proposed questionnaires, 
those who would be unable to make lifestyle changes because of physical or mental limitations and 
those who do not live freely within the community. It is anticipated that five or six invitees will agree to 
take part and include a range of possible co-morbidities and characteristics of interest. We recognise 
that GPs may choose to invite those whom they consider most likely to participate and to be compliant 
with the study protocol, thus introducing a possible risk of selection bias. However, we consider that the 
inclusion criteria will identify patients for whom the tool has relevance and they will have valuable 
contributions to make to the study findings. Moreover, possible factors influencing GPs’ selection of 
patients will be sought through their participation in focus groups which will explore their perceptions of 
the applicability of the tool to a wider population than that included in the study sample. 

Page 3 of 4 
 
Inclusion/exclusion criteria 
Participants will have a Body Mass Index (BMI) greater than 30, indicating obesity, or low levels of 
physical activity (assessed by their general practitioner (GP), using the General Practice Physical 
Activity Questionnaire (GPPAQ), a tool recommended for use in primary care). We will include patients 
who have been diagnosed as having CHD and patients without a diagnosis of CHD but who are at high 
risk of CVD (10-year estimated risk of at least 20%, as assessed by the GP). Thus, our sample will 
include patients who would most benefit from behaviour change. Exclusion criteria, as listed above, are 
based on limitations in using the ‘SHARE-D’ tool in its current format or in making diet or PA change.   
 
Sample size 
As a feasibility study is planned, a formal sample size calculation has not been conducted. We plan to 
interview five patients from five practices (expecting less than 50% response from invitees in each 
practice) giving a total study sample size of 25. This size of sample will allow inclusion of patients with a 
range of conditions, socio-economic characteristics and community support. Selecting a practice from 
each of five different health and social care trusts allows inclusion of patients who have access to 
different models of health and social care provision of services to support healthy lifestyles. 
 
Recruitment of patients 
The researcher will provide a study invitation letter for the lead GP from each practice to, if he/she 
approves the content, send to selected patients with a study information sheet, reply slip and stamped 
addressed envelope so that patients will be encouraged to return the reply slip, indicating their decision 
about taking part in the study, to the practice. Those who agree to participate will, with their consent, be 
telephoned by the researcher to arrange a mutually convenient time and location for a meeting at which 
the researcher will explain the study fully and ask the patient to sign a consent form if they still agree to 
participate. They will have the opportunity to ask any questions about the study and will be assured of 
confidentiality. 
 
Data collection 
With consent, at their initial meeting, participants will complete the DINE (Roe et al, 1994) and RPAQ 
(Besson et al, 2010) questionnaires, administered by the researcher, a post-doctoral fellow with 
experience in working with patients with coronary heart disease, to provide a baseline measure of diet 
fat and fibre intake and a measurement of physical activity. Then, in consultation with a health 
professional in the practice (nurse or general practitioner), they will complete a decision tool, a paper-
based questionnaire which will highlight the need for personal decisions regarding lifestyle behaviour. 
Based on current evidence, relating to factors known to be important in behaviour change, this tool will 
provide information about benefits and risks associated with diet and physical activity and will include a 
series of questions to encourage individuals to consider their personal lifestyle behaviours and how to 
make changes. Based on a review of theories of behaviour change, with a focus on health beliefs, social 
support and self-determination, this will facilitate their consideration of their own beliefs, attitudes and 
values, as well as conditions existing within their social and physical environments, which would support 
or hinder possible changes in their behaviour. The duration of the meeting and data relating to their age, 
gender, medical conditions, medication and social circumstances will also be recorded. Participants will 
be offered some Northern Ireland Chest, Heart & Stroke literature/leaflets outlining the importance of 
healthy lifestyles and they may keep these and refer to them at their convenience. 
 
The decision tool to be tested is designed to encourage conversation between a patient and health 
professional and support shared decision-making. It allows opportunities for the patient to ask questions 
at any time. After a shared decision has been made regarding possible changes in diet and physical 
activity, the researcher will arrange contact again for one month later. 
At the end of the initial meeting participants will be invited to wear an Actigraph GT3X accelerometer for 
a 7 day period, to provide an objective measure of their physical activity. If they agree to do so, 
arrangements will be made to collect the device at the end of this period. We have considered the risk of 
potential confounding effects on behaviour change of using an accelerometer (reactivity effects) but 
concluded that these would be outweighed by the additional information gained through testing the 
feasibility of its use. In a definitive study it would be valuable to include an objective measure to assess 
the impact of the intervention on physical activity behaviour change. 
 
 

Page 4 of 4 
Follow-up contact 
At a one month follow-up meeting the researcher will ask about progress in lifestyle change, repeat the 
DINE and RPAQ questionnaires, consider and record possible unmet needs for support in change, help 
participants to identify appropriate sources of support, provide ‘signposting’ to these and answer any 
queries. A written record will be made of whether they have been in contact with their GP or practice 
nurse or have received any support from health professionals, community based organisations/facilities 
or friends and family, relating to lifestyle change. At the completion of this meeting the researcher and 
participant will agree arrangements for contact to be made again, two months later. 
 
At 3 months after the initial meeting, the researcher will again meet participants to repeat the DINE and 
RPAQ questionnaires and record unmet and met needs for support, with particular note of the 
availability and use of health service and community resources in supporting lifestyle behaviour change. 
Following a semi-structured interview approach, participants’ views of the decision-making tool will be 
sought and noted in writing by the researcher. Questions will be asked about each section, and each 
question, in relation to usefulness, clarity and relevance regarding helping them to adopt and sustain 
healthy lifestyles. Opinions will be sought regarding possible different or preferred methods of its 
administration (eg. mobile application, with/without health professional). Responses will not be 
audiotaped in order to minimize possible inhibition of expression of frank opinion, since there is 
recognition that people who attempt to make lifestyle changes and do not succeed may be embarrassed 
by their lack of success and sensitive about an ongoing need to make changes. Also at this 3-month 
meeting patients will be again invited to wear an accelerometer for a 7-day period to record physical 
activity. 
 
Semi-structured interviews with health professionals 
After patients’ interviews and questionnaires have been completed in all five practices and their views on 
the decision tool have been explored, interviews will be conducted in each practice with GPs who invited 
patients’ participation and health professionals with whom the patients have consulted during the time of 
the study. We hope to recruit at least one GP or one practice nurse per practice. If more than two health 
professionals in a practice wish to participate then we would attempt to conduct a focus group in that 
practice. The aim of the focus groups is to ascertain if the patients have shared any information relating 
to their use of the decision tool in consultations and the views of GPs and nurses regarding its potential 
utility in everyday practice. This will include their opinions on how the tool could be used during a 
consultation, the types of patients for whom the use of the tool would be considered appropriate, the 
questions included in it and what could be included in a potential electronic application of the decision 
tool. Primary questions for these groups will also be informed by analysis of the patients’ interviews. The 
interviews or focus groups with health professionals will be audio-taped, with consent, and the recorded 
data will be transcribed verbatim, anonymously, for analysis. 
 
Data analysis 
The lifestyle questionnaires DINE, to ascertain diet habits, and RPAQ, to measure physical activity, will 
be used in order to record a measure of these aspects of participants’ lifestyles during the time of the 
study, in order to provide objective contextual detail for the qualitative findings. Comparisons will be 
made of DINE fibre, fat and unsaturated fat scores and of RPAQ scores between the baseline 
measurements and at one month and at 3 months, so that change may be tracked for individuals. 
Descriptive statistics will be reported only. These data will guide in sample size estimations for a later 
study. Data derived from the accelerometers (minutes of moderate and vigorous physical activity), at 
baseline and at the 3-month follow-up point, will provide an objective measure of physical activity. 
Qualitative analysis of patients’ opinions of the decision tool and reasons for any behaviour change 
undertaken during the study, which will have been noted in writing by the researcher at the second and 
third meetings, will be carried out. Experiences of incentives and barriers to lifestyle behaviour change 
will be sought. Data collection and analysis will be iterative. Thematic analysis will be employed, using 
the constant comparative method and the support of the computer software programme NVivo (QSR, 
2010). Focus groups and interviews with health professionals at the five practices will be analysed 
qualitatively using a theoretical framework analysis. All data will be recorded anonymously and no 
individual will be identified in any report of the study.