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

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

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

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)

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

Pre-clinical phase AimsMethodsData sources Explore evidence of specific educational needs of a screen- detected population with dysglycaemia in primary care Literature review Exploring theory Medline search : 35 articles found, 14 included Health promotion and education theories

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

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) Internal versus external motivation Perceived competence Social relatedness Internal versus external motivation Perceived competence Social relatedness Self-regulatory motivation Knowledge and skills Social reflection Self-regulatory motivation Knowledge and skills Social reflection Expectations and ambivalence Self-efficacy Collective self-efficacy Social support Expectations and ambivalence Self-efficacy Collective self-efficacy Social support

Phase I: Intervention modelling AimsMethodsData sources To identify intervention components To define the pedagogical activities To identify collaborative and training needs Expert meetings Worksheet testing Physiotherapists, GPs, dieticians and nurses with expertise in dysglycaemia and health promotion 12 persons with newly diagnosed type 2 diabetes from a local diabetes class

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 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. Table 1. The relationship between the text of the intervention letter and theoretical constructs Components in the intervention

Action Competence Individual interview Group meetings Health beliefs Readiness to change Outcome expectan- cies Action plan Feed back Looking ahead Social support Informed decision- making Motivation Informed decision-making Action experienceSocial involvement

Phase II: Pilot test of intervention AimsMethodsData sources To identify final sequences and components To evaluate the feasibility of delivering in primary care Observation Video recording Focus groups Short questionnaire Informal evaluation Nurses (n=2) and participants (n=16) Nurses (n=2) and dieticians (n=1) Participants groups (n=16) Participants groups (n=14) Health care educators (n=7)

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.”]

Action Competence Individual interview Group meetings Health beliefs Readiness to change Outcome expectan- cies Action plan Feed back Looking ahead Social support Informed decision- making Motivation Informed decision-making Action experience 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- rativelappro ach. 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. Nurse and GP Nurse Dietician Physio- therapist Dietician Nurse Social involvement

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) HbA 1c Lipids Body Mass Index Cardiovascular risk score

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

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?