16 th Nordic Congress of General Practice Copenhagen, May 14 , 2009

1. Anglo-Danish-Dutch study of intensive treatment in people with screen detected diabetes in primary care Development of the “Ready to Act” intervention 16th Nordic Congress of General PracticeCopenhagen, May 14, 2009 Helle Terkildsen Maindal, RN, MPH, PhD Department of General Practice, Aarhus University, Denmark

2. Aims of this presentation • The intervention developmental process • Knowledge of the target group • Choice of theories • Translation of evidence and theory • Define a replicable intervention • Choice of outcomes

3. What kind of intervention is needed? • People with prediabetes and T2 diabetes diagnosed by screening in general practice, recruited from the ADDITION-study * • The screening-procedure was followed by early multi-factorial behavioural and pharmacological interventions • This intervention is one of the behavioural interventions and aims at individual health promotion *The Anglo-Danish-Dutch Study of Intensive Treatment in People with Screen-Detected Diabetes in Primary Care

4. Yet another education programme? Known • Education combined with activation improves self-management and health outcomes (Renders, Norris, Glasgow) • Social support enhances lifestyle adjustments (Van Dam, Norris) • Support from nurse/case manager/multi-disciplinary teams improves outcome in patient education (Renders, Loveman) Not known • Special needs of a newly diagnosed screen-detected population (Adriaanse, Thoolen ) • Efficient intervention components (Norris, Gary)

5. Method: MRC, UK Framework for design and evaluation of the intervention Campbell, M. et al. BMJ 2000;321:694-696

6. Pre-clinical phase

7. Empirical evidence ”Right at the beginning you need somebody’s arms around you” (Peel, 2004) ”No symptoms, no problem?” (Adriaanse, 2003, Lawton, 2005) ”My GP focus on the blood sugars - I focus on my cooking” (Woodcock,2001) ”I feel I lack of knowledge and confidence” (Lawton, 2005) ”It is a mild disease” (Adriaanse, 2002)

8. Theoretical phase (pre-clinical) Action Learning theory (Tilbury 2005, Burke 2007) Social Cognitive theory (Bandura 1997,2004) Self-determination theory (Deci og Ryan 2000, 2002, 2005) • Self-regulatory motivation • Knowledge and skills • Social reflection • Expectations and ambivalence • Self-efficacy • Collectiveself-efficacy • Social support • Internal versus external motivation • Perceivedcompetence • Social relatedness

9. Phase I: Intervention modelling

10. Table 1. The relationship between the text of the intervention letter and theoretical constructs Theoretical constructs Self-regulatory motivation (ALT) Knowledge and skills (ALT) Social reflection (ALT) Expectations/ambivalence (SCT) Self-efficacy (SCT) Collective self-efficacy (SCT) Social support (SCT) Internal motivation (SDT) Perceived competence (SDT) Social relatedness (SDT) Translation of theory Components in the intervention Enhance motivation Individual motivational interviews aim to clarify health beliefs, expectations, ambivalence and self-efficacy/perceived competence. Intrinsic motivation to individual actions is supported. Goal setting and action planning is introduced. Feed back is provided Support Informed decision-making Group sessions on knowledge of health risks and health actions e.g. diet, exercise, action planning is provided by multidisciplinary teams, which means that diabetes/practice nurses, dietician, physiotherapist, and GPs work to tailor an intervention to meet the specific needs of a particular group. Achieve Action experience Action experiences were planned as part of each session and the participants were offered e.g. supervised aerobic exercise in safe environment, and skills training according to blood sugar measurements. During the group sessions the participants work with goal setting and action planning to prepare them for further actions after the intervention. Support Social involvement The intervention is primarily group-based to support the exchange of experiences and to build up collective self-efficacy. The intervention was locally based to make local ressources visible (health professionals, peers, environments.

11. Informed decision-making Motivation Action experience Social involvement Individualinterview Individualinterview Group meetings Feed back Looking ahead Social support Informed decision-making Health beliefs Readiness to change Outcome expectan-cies Action plan Action Competence

12. Phase II: Pilot test of intervention

13. Evaluation after pilot tests • Evaluation of the intervention process • Some participants called for more ”pressurising” • The participant-centred approach was reached • The number of group versus individual sesssions were sufficient • [“I am glad they [the educators] did not talk all the time; if they do, something is lost. No, the way we got involved kept me awake.”] • Evaluation of the intervention outcome • Participants reported readiness for behaviour changes • Participants felt a positive influence on their health behaviour • Participants felt motivated by learning new skills • [“The bikes at the physiotherapist were so good, I got my arms and legs moving in a way I did not know I could.”]

14. Informed decision-making Motivation Action experience Social involvement Individualinterview Individualinterview Group meetings 1 Cardio-vascular risk and dys-glycaemia: Symptoms, signs, physiology, causes and treatment. Action planning. 2 Preventive actions: Health behaviour and medical treatment. The collabo-rativelapproach. 3 Actions related to diet: Blood glucose, lipids, weight and well-being. Change strategies. Action planning. 4 Actions related to physical activity: Physical exercise and blood glucose. Change strategies. Resources and barriers. 5 Actions related to diet: Health beliefs. Foods composi-tion and purchase. 6 Actions related to diet: Skill training. Eating patterns. Everyday and occasional food. 7 Actions related to physical activity: Skill training. Effects on risk, weight and blood glucose. 8 Attitude to risk and diagnosis: Variations in feelings. Action planning. Support and local resources. Feed back Looking ahead Social support Informed decision-making Health beliefs Readiness to change Outcome expectan-cies Action plan Nurse and GP Nurse Physio-therapist Physio-therapist Nurse Nurse Dietician Dietician Dietician Nurse Action Competence

15. Choice of outcomes • Initial outcomes (3 months) • Autonomy support • Perceived outcome • Recommend the intervention to others • Intermediary outcomes (1 year) • Treatment motivation • Perceived competence • Long-term outcomes (1 year) • Activation • Dietary quality • Physical activity • Long-term outcomes (3 year) • HbA1c • Lipids • Body Mass Index • Cardiovascular risk score

16. Conclusion The MRC framework provided useful guidelines • The Preclinical phase helped to identify intervention components by exploring theories and evidence on the educational needs of the specific target group • In Phase I, the components were modelled in collaboration with participants and health professionals • In Phase II, the content and logistics of the final intervention were refined, and supported the choice of outcomes • The model provided the transparent and systematical development of a well-defined intervention to be delivered in a RCT Financial support: University College of Jutland, Danish Council of Nursing, The Danish Diabetes Association, Novo Nordic Foundation DK

17. For discussion... • Did the empirical studies of other study populations reveal the needs of our target group sufficiently? • Should the intervention development investigate the reach of the specific intervention (12 weeks, group sessions, multi-disciplinary programme)? • Did we choose the right outcomes? – • And should we have investigated the validity and responsiveness of the scales?