1. “Ready to Act“ - a health education programme 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 Reach, process evaluation and effects of the “Ready to Act” intervention

2. Aims of this presentation To illustrate the challenges of the implementation and evaluation of a health-promoting intervention for people screen-detected in general practice with type 2 diabetes, impaired glucose tolerance or impaired fasting glucose

3. Today’s presentation Target group Brief introduction to the intervention Attendance Initial outcomes Intermediary outcomes Long-term outcomes

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

5. Study population and design 509 randomised at the individual level (2:1) 322 Intervention187 Control Conventional treatment ADDITION-study, general practice, Denmark Intensive treatment

6. People with screen-detected dysglycaemia ”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 knowledge and confidence” (Lawton, 2005) ”My GP focuses on the blood sugars - I focus on my cooking” (Woodcock,2001) ”My GP focuses 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)

7. 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- rative approach. 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 diagnose: Variations in feelings. Action planning. Support and local resources. Nurse and GP Nurse Dietician Physio- therapist Dietician Nurse Social involvement

8. 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

9. Baseline characteristics Randomisation groups AllnInterventionnControln Age, year mean (SD)61.8 (7.2)50962.2 (6.9)32261.2 (7.6)187 Sex, % female46,850947,232246187 Diagnosis, % prediabetes 47,55094632250,3187 Diagnosis duration, year mean (SD) 1.7 (1.8)5091.8 (1.8)3221.6 (1.8)187 Body mass index (kg/m 2 ) 30.0 (5.3)50129.9 (5.1)31530.2 (5.8)186 Glycated haemoglobin (%) 6.0 (0.9)5096.0 (0.8)3226.1 (0.9)187

10. Intervention reach in the randomised controlled trial Intervention group (N=322) 38% (n=123) Accepted the programme and completed 6% (n=19) Accepted, but did not complete 34% (n=109) Declined the invitation 22% (n=71) No response Control group (N=187)

11. Effect evaluation Moderate effects on psychological outcomes No effects on diet, physical activity or activation No evidence of clinical outcomes (yet) Process evaluation Reach 38% Perceived autonomy support median 6,2 (max. 7) 90% would recommend the intervention to others 80% perceived positive or very positive outcomes Results of 1-year follow-up (short form!) Are these conflicting results? Not necessarily …

12. Discussion Did the intervention work? Did we choose the right outcomes? Do we have sufficient evidence for further implementation? If further implementation... Do we need further evidence? Are there critical areas to be adjusted?

13. Conclusion and perspectives Transparent and systematic intervention development 44% accepted the intervention, 38% completed Positive process evaluation Moderate effects – clinical relevance? Intervention linked to health promotion activities after early detection of T2 diabetes and prediabetes remains a future challenge…. ”Absence of evidence is not evidence of absence” (Bland & Altman 1995) Financial support: University College of Jutland, Danish Council of Nursing, The Danish Diabetes Association, Novo Nordic Foundation DK