White, A. J. S., Kellar, I., Prevost, A. T., Kinmonth, A. L., Sutton, S., Canny, M., & Griffin, S. J. (2011). Adherence to hypoglycaemic medication among people with type 2 diabetes in primary care. Primary care diabetes, 1-7. Primary Care Diabetes Europe. doi:10.1016/j.pcd.2011.07.004 – Full text

AIMS: To assess levels and correlates of adherence to hypoglycaemic medication among patients offered organised general practice diabetes care. METHODS: 60 patients prescribed oral hypoglycaemic medication were recruited to a two-month prospective study. Prescribed doses taken and days on which the prescribed number of doses was taken were measured by MEMS (Medication Event Monitoring System). RESULTS: Overall 99.1% of prescribed doses were taken (median, IQR: 96.8-100%), this was inversely correlated with daily dose frequency (Spearman’s rho=0.37, p=0.004). Only 4 patients (6.7%) took less than 90% of prescribed doses. The prescribed dose was taken on 96.4% of days (median, IQR: 89.1-98.2%), this was correlated with age (rho=0.26, p=0.047) and inversely correlated with HbA(1c) levels (rho=-0.29, p=0.02) and daily dose frequency (rho=-0.33, p=0.009). Adherence to metformin was less than to other hypoglycaemic medication (Z=-3.48, p=0.0005). CONCLUSIONS: A dispensing practice with a well-run diabetes service can support high rates of adherence to hypoglycaemic medication. Before changing medication, low adherence might be considered as a possible cause of progressive hyperglycaemia, particularly among patients prescribed metformin more than once a day. Selective monitoring with MEMS may have a clinical as well as a research role in such people.

Kellar, I., Mann, E., Kinmonth, a L., Prevost, a T., Sutton, S., & Marteau, T. M. (2011). Can informed choice invitations lead to inequities in intentions to make lifestyle changes among participants in a primary care diabetes screening programme? Evidence from a randomized trial. Public health, 44(0), 1-8. Elsevier Ltd. doi:10.1016/j.puhe.2011.05.010 – Full text

OBJECTIVE: To test whether information about benefits and harms of screening for type 2 diabetes increases intentions to make lifestyle changes amongst attenders, predominantly among the socially advantaged and those with a strong future time orientation. STUDY DESIGN: Planned subgroup analysis of attenders for screening participating in a randomized controlled trial of an informed choice invitation vs a standard invitation to attend for type 2 diabetes screening. METHODS: Potentially eligible participants were identified from practice registers using routine data which were used to calculate risk scores for diabetes for all aged 40-69 years without known type 2 diabetes and area deprivation based on post code. In total, 1272 individuals in the top 25% risk category were randomized to receive one of two invitations to attend their practices for screening: an informed choice invitation or a standard invitation. The subsequent attenders completed self-report measures of future time orientation and deprivation immediately before undergoing a screening test. RESULTS: Individual-level deprivation demonstrated a significant moderator effect [F (4,635) = 4.32, P = 0.002]: individuals who were high in deprivation had lower intentions to engage in lifestyle change following receipt of the informed choice invitation. However, intentions were not patterned by deprivation when it was assessed at the area-level using the Index of Multiple Deprivation 2007. The hypothesized moderating effect of future time orientation on invitation type was also supported [F(14,613) = 2.46, P = 0.002): individuals low in future time orientation had markedly lower intentions to engage in lifestyle change following receipt of an informed choice invitation compared with a standard invitation for screening. CONCLUSION: Efforts to enhance informed choice where the implications of diagnosis are a requirement for lifestyle change may require that the immediate benefits are communicated, and efforts to address the apparent barriers to diabetes self-care are made, if the potential for inequity is to be avoided.

Marteau, T. M., Mann, E., Prevost, A. T., Vasconcelos, J. C., Kellar, I., Sanderson, S., Parker, M., et al. (2010). Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): randomised trial. BMJ: British Medical Journal, 340. BMJ Group. doi:10.1136/bmj.c2138 - Full text

Objective To compare the effect of an invitation promoting informed choice for screening with a standard invitation on attendance and motivation to engage in preventive action.

Design Randomised controlled trial.

Setting Four English general practices.

Participants 1272 people aged 40-69 years, at risk for diabetes, identified from practice registers using a validated risk score and invited to attend for screening.

Intervention Intervention was a previously validated invitation to inform the decision to attend screening, presenting diabetes as a serious potential problem, and providing details of possible costs and benefits of screening and treatment in text and pie charts. This was compared with a brief, standard invitation simply describing diabetes as a serious potential problem.

Main outcome measures The primary end point was attendance for screening. The secondary outcome measures were intention to make changes to lifestyle and satisfaction with decisions made among attenders.

Results The primary end point was analysed for all 1272 participants. 55.8% (353/633) of those in the informed choice group attended for screening, compared with 57.6% (368/639) in the standard invitation group (mean difference ?1.8%, 95% confidence interval ?7.3% to 3.6%; P=0.51). Attendance was lower among the more deprived group (most deprived third 47.5% v least deprived third 64.3%; P<0.001). Interaction between deprivation and effect of invitation type on attendance was not significant. Among attenders, intention to change behaviour was strong and unaffected by invitation type.

Conclusions Providing information to support choice did not adversely affect attendance for screening for diabetes. Those from more socially deprived groups were, however, less likely to attend, regardless of the type of invitation received. Further attention to invitation content alone is unlikely to achieve equity in uptake of preventive services.

Trial registration Current Controlled Trials ISRCTN 73125647.

Prestwich, a, & Kellar, I. (2010). How can the impact of implementation intentions as a behaviour change intervention be improved? Revue Européenne de Psychologie Appliquée/European Review of Applied Psychology. Elsevier Masson SAS. doi:10.1016/j.erap.2010.03.003 - Full text

Interventions requesting individuals to form implementation intentions, specific plans regarding how and when to enact behaviour, have been shown to be effective in changing a wide range of health, social, and organisational behaviours. A small proportion of studies have sought to identify, within full-factorial designs, under what circumstances and for whom implementation intention-based interventions are most effective. This review covers this issue. A number of potential moderators of the effects of implementation intentions on behaviour were identified (intentions, motivation type, collaboration, plan reminders, goal type, plan type, conscientiousness, perfectionism, procrastination, stress). Of these, the strength of one's intentions have been tested, and supported, most often as a moderator of implementation intention effects. For some of these moderators (e.g., conscientiousness, goal difficulty) the results were contradictory but for others the results were more consistent (e.g., motivation type, plan reminders). Additional moderators might be identified by comparing effects of implementation intentions across studies.

Mann, E., Kellar, I., Sutton, S., Kinmonth, A. L., Hankins, M., Griffin, S., & Marteau, T. M. (2010). Impact of informed-choice invitations on diabetes screening knowledge, attitude and intentions: an analogue study. BMC public health, 10(1), 768. BioMed Central Ltd. doi:10.1186/1471-2458-10-768 - Full text

Despite concerns that facilitating informed choice would decrease diabetes screening uptake, 'informed choice' invitations that increased knowledge did not affect attendance (the DICISION trial). We explored possible reasons using data from an experimental analogue study undertaken to develop the invitations. We tested a model of the impact on knowledge, attitude and intentions of a diabetes screening invitation designed to facilitate informed choices.

Mann, E., Prevost, a T., Griffin, S., Kellar, I., Sutton, S., Parker, M., Sanderson, S., et al. (2009). Impact of an informed choice invitation on uptake of screening for diabetes in primary care (DICISION): trial protocol. BMC public health, 9, 63. doi:10.1186/1471-2458-9-63 - Full text

Screening invitations have traditionally been brief, providing information only about population benefits. Presenting information about the limited individual benefits and potential harms of screening to inform choice may reduce attendance, particularly in the more socially deprived. At the same time, amongst those who attend, it might increase motivation to change behavior to reduce risks. This trial assesses the impact on attendance and motivation to change behavior of an invitation that facilitates informed choices about participating in diabetes screening in general practice. Three hypotheses are tested: 1. Attendance at screening for diabetes is lower following an informed choice compared with a standard invitation. 2. There is an interaction between the type of invitation and social deprivation: attendance following an informed choice compared with a standard invitation is lower in those who are more rather than less socially deprived. 3. Amongst those who attend for screening, intentions to change behavior to reduce risks of complications in those subsequently diagnosed with diabetes are stronger following an informed choice invitation compared with a standard invitation.

Farmer, A. J., Prevost, A. T., Hardeman, W., Craven, A., Sutton, S., Griffin, S. J., Kinmonth, A.-L., for The Support and Advice for Medication Trial Group (2008). Protocol for SAMS (Support and Advice for Medication Study): A randomised controlled trial of an intervention to support patients with type 2 diabetes with adherence to medication. BMC Family Practice, 9, 20. BioMed Central. doi:10.1186/1471-2296-9-20 - Full text

Background
Although some interventions have been shown to improve adherence to medication for diabetes, results are not consistent. We have developed a theory-based intervention which we will evaluate in a well characterised population to test efficacy and guide future intervention development and trial design.

Methods and Design
The SAMS (Supported Adherence to Medication Study) trial is a primary care based multi-centre randomised controlled trial among 200 patients with type 2 diabetes and an HbA1c of 7.5% or above. It is designed to evaluate the efficacy of a two-component motivational intervention based on the Theory of Planned Behaviour and volitional action planning to support medication adherence compared with standard care. The intervention is delivered by practice nurses. Nurses were trained using a workshop approach with role play and supervised using assessment of tape-recorded consultations. The trial has a two parallel groups design with an unbalanced three-to-two individual randomisation eight weeks after recruitment with twelve week follow-up. The primary outcome is medication adherence measured using an electronic medication monitor over 12 weeks and expressed as the difference between intervention and control in mean percentage of days on which the correct number of medication doses is taken. Subgroup analyses will explore impact of number of medications taken, age, HbA1c, and self-reported adherence at baseline on outcomes. The study also measures the effect of dispensing medication to trial participants packaged in the electronic medication-monitoring device compared with conventional medication packaging. This will be achieved through one-to-one randomisation at recruitment to these conditions with assessment of the difference between groups in self-report of medication adherence and change in mean HbA1c from baseline to eight weeks. Anonymised demographic data are collected on non-respondents. Central randomisation is carried out independently of trial co-ordination and practices using minimisation to adjust for selected confounders.

Discussion
The SAMS intervention and trial design address weaknesses of previous research by recruitment from a well-characterised population, definition of a feasible theory based intervention to support medication taking and careful measurement to estimate and interpret efficacy. The results will inform practice and the design of a cost-effectiveness trial [ISRCTN30522359].

Kellar, I., Sutton, S., Griffin, S., Prevost, a T., Kinmonth, A. L., & Marteau, T. M. (2008). Evaluation of an informed choice invitation for type 2 diabetes screening. Patient education and counseling, 72(2), 232-8. doi:10.1016/j.pec.2008.04.005 – Full text

OBJECTIVE: To evaluate an innovative invitation designed to facilitate informed choices for undergoing screening for type 2 diabetes. METHODS: Four hundred and seventeen people aged 40-69 years (sex: F 53%/M 47%), without known diabetes, recruited from street locations. Participants were randomised to receive one of two hypothetical invitations for screening for type 2 diabetes; one based on General Medical Council guidelines and combined with a decisional balance sheet, the other a brief traditional invitation. Informed choice was assessed immediately after the invitation and 3 weeks later using measures of knowledge, attitudes and intentions. RESULTS: Two weeks after receipt of the invitation, the proportion of informed choices was significantly higher among participants who received the informed choice invitation compared with those who received the traditional invitation (42.9% versus 11.2%; difference=31.7%, 95% CI: 22.5-40.5%; p<0.001). Mean knowledge scores were significantly higher after the receipt of the invitation designed to facilitate informed choices than after the traditional invitation (5.49 versus 3.90; t(405)=10.106, p<0.001). Intentions to participate in screening were unaffected by receipt of the informed choice invitation. CONCLUSION: Compared with a traditional invitation, receipt of the invitation designed to facilitate informed choices increased the proportion of informed choices about type 2 diabetes screening attendance. PRACTICE IMPLICATIONS: : Although the new invitation was associated with better knowledge of screening it had no differential effect on intention and its effect on attendance still requires evaluation.

Kellar, I., & Abraham, C. (2005). Randomized controlled trial of a brief research-based intervention promoting fruit and vegetable consumption. British journal of health psychology, 10(Pt 4), 543-58. doi:10.1348/135910705X42940 – Full text

Objective. The present study sought to test the efficacy of a brief research-based, leaflet-like intervention to promote eating the recommended daily intake of fruit and vegetables (RDIFV).

Design. A controlled, pre- post-test experimental study with random allocation and a 1 week self-report behavioural follow-up was conducted.

Method. The intervention employed persuasive communication targeting self-efficacy and intention, and invited participants to form implementation intentions in relation to acquiring and preparing fruit and vegetables for consumption.

Results. Intervention participants had stronger post-intervention intentions to consume the RDIFV, and higher anticipated regret in relation to failing to do so, compared with controls, controlling for pre-intervention scores. At follow-up, the intervention group was found to have eaten more fruit and vegetables and to have consumed the RDIFV more frequently.

Discussion. It is concluded that this study supports the previously reported power of implementation intentions to prompt enactment of intentions, and that a brief research-based leaflet-like intervention could result in immediate enhancement of intentions and anticipated regret, and promote greater fruit and vegetable consumption.