Effect of a participant-driven health education programme in primary care for people with hyperglycaemia detected by screening: 3-year results from the Ready to Act randomized controlled trial (nested within the ADDITION-Denmark study).

ABSTRACT

AIM: To assess whether a 12-week participant-driven health education programme offered to individuals with screening-detected hyperglycaemia in Danish primary care would lead to improvements in cardiovascular risk factors, health behaviour and patient-reported outcomes after 3 years. METHODS: We conducted a randomized controlled trial in 509 patients with screening-detected hyperglycaemia (impaired fasting glucose, impaired glucose tolerance or type 2 diabetes) from 33 general practices in Denmark. Individuals were pre-randomized to receive (i) routine care (n = 187), or (ii) an invitation to participate in the Ready to Act health education programme (n = 322). The programme was delivered over 12 weeks in primary care and focused on motivation, action experience, informed decision-making and social involvement to promote health behaviour change. The primary outcome was 10-year modelled cardiovascular risk. RESULTS: Of 322 individuals, 123 (38%) received the intervention and 436/509 individuals (86%) returned for follow-up assessment. There was no difference between the trial groups in modelled cardiovascular risk at 3 years (relative difference 1.01; 95% CI 0.84 to 1.23). Total cholesterol was lower (-0.24mmol/l, 95% CI -0.45 to -0.03, P = 0.027), and patient activation was higher in the intervention than in the control group (5.3, 95% CI 0.97 to 9.7). No other between-group differences were observed for any cardiovascular risk factor, health behaviour or patient-reported outcome variables. Subgroup analyses suggested that the intervention was more beneficial in those with impaired fasting glucose/impaired glucose tolerance than in those with type 2 diabetes. CONCLUSION: For patients with screening-detected hyperglycaemia, a participant-driven health education programme was not associated with improvements in most clinical, behavioural and patient-reported outcomes after 3 years of follow-up.