The effect of guided self-determination on self-management in persons with type 1 diabetes mellitus and HbA(1c) ≥64 mmol/mol: a group-based randomised controlled trial

OBJECTIVES: To determine whether the impact of guided self-determination (GSD) applied in group training (GSD-GT) in people with chronically elevated HbA(1c) and type 1 diabetes mellitus (DM) was superior to ‘care as usual’ in improving HbA(1c) and psychological functioning. SETTING: An outpatient clinic at a university hospital in Western Norway. PARTICIPANTS: A total of 178 adults (all Caucasian) aged 18–55 (mean age 36.7±10.7, 62% women) with type 1 DM for at least 1 year and HbA(1c) ≥64 mmol/mol (8.0%) were randomly assigned to participate in either GSD-GT or a control group (CG). Exclusion criteria were severe comorbidity, major psychiatric disorder, cognitive deficiency/language barriers and pregnancy. INTERVENTION: Intervention group met seven times for 2 hours over 14 weeks to promote patient autonomy and intrinsic motivation using reflection sheets and advanced professional communication in accordance with the GSD methodology. PRIMARY AND SECONDARY OUTCOME MEASURES: The primary outcome was HbA(1c) and secondary outcomes (all outcomes 9 months post intervention) were self-monitored blood glucose frequency, self-reported diabetes competence, autonomy support by healthcare providers (Health Care Climate Questionnaire), autonomous versus controlled diabetes motivation (Treatment Self-Regulation Questionnaire), diabetes distress (Problem Areas In Diabetes Scale (PAID) and Diabetes Distress Scale (DDS)), self-esteem (Rosenberg Self-Esteem Scale) and psychological well-being (World Health Organization five-item Well-Being Index scale). RESULTS: Among participants allocated to the GSD-GT (=90) 48 completed the study, whereas 83 completed in the CG (n=88). With 95% CIs GSD-GT did not have effect on HbA(1c) (B −0.18, CI (−0.48, 0.12), p=0.234). GSD-GT improved autonomy-motivated behaviour (B 0.51, CI (0.25, 0.77), p<0.001), diabetes distress (PAID, B −6.96, CI (−11.40, −2.52), p=0.002), total DDS (B −5.15, CI (−9.34, −0.96), p=0.016), DDS emotional burden (B −7.19, CI (−13.20, −1.19), p=0.019) and self-esteem (B 1.43, CI (0.34, 2.52), p=0.011). CONCLUSIONS: Results from this behavioural intervention must be interpreted cautiously because of recruitment and attrition problems. Medical outcomes did not improve. Psychological outcomes improved, especially reduced diabetes distress. TRIAL REGISTRATION NUMBER: Clinical Trials.gov NCT 01317459.