The SUGAR handshake intervention to prevent hypoglycaemia in elderly people with type 2 diabetes: process evaluation within a pragmatic randomised controlled trial.

BACKGROUND

The SUGAR Handshake is a pharmacist-led educational intervention to prevent hypoglycaemia in elderly people with type 2 diabetes mellitus (T2DM). A process evaluation was conducted alongside the ROSE-ADAM pragmatic randomized controlled trial (RCT) to assess the implementation of the intervention and study procedures, explore mechanisms of impact, and examine future scalability.

METHODS

This mixed-methods process evaluation was nested within a single-centre RCT conducted at outpatient clinics in a Jordanian hospital. Routine monitoring quantitative data assessed adherence to the intervention components and study activities, and estimated reach. Qualitative data, collected through semi-structured interviews with 12 purposively selected participants on Days 45 and 90 of enrolment, captured experiences with the intervention and usual care. Thematic analysis was used for qualitative data; descriptive statistics and inferential tests were applied to quantitative data.

RESULTS

The intervention was well implemented: 104 of 106 participants (98.11%) continued the full intervention, with a 100% reach to those enrolled in the trial. Participants showed high adherence to study activities (mean ± SD: 88.07 ± 9.33 documented days on diaries; 77.97 ± 18.87 fasting blood glucose measurements). Intervention reach was 100%. Participants described the intervention as informative, easy to follow, and helpful in avoiding hypoglycaemia and the side-effects of antidiabetic medications. Key facilitators included trust in pharmacists, altruism, and social support. Reported barriers were people's health status, age-related conditions, and stress.

CONCLUSIONS

This process evaluation highlights the SUGAR Handshake's potential for broader implementation and scale-up. By addressing identified barriers, future educational interventions may enhance adherence, improve patient outcomes, and advance hypoglycaemia management in diabetes care.

TRIAL REGISTRATION: Clinicaltrials.gov (NCT04081766), registration date 4,920,219.