Control of Hypertension and diAbetes in MINas Gerais

This scale up implementation study has mixed-methods, and comprehends four steps: (1) needs assessment, (2) baseline period, (3) cluster RCT and (4) qualitative study. The RE-AIM planning and evaluation framework will be used in this research project, which includes: reach (R), efficacy (E), adoption (A), implementation (I), and maintenance (M). The Adaptation Framework might be used as well, in case adaptations need to be conducted during the intervention, taking into account the COVID-19 pandemic and possible new waves.

• A standardized structured questionnaire will be developed with open questions about the physical and technological structure, human resources and challenges managing patients with hypertension and DM, in order to carry out a brief situational diagnosis.
• A baseline period of three months will be established to assess the basal condition of patients. Individuals will be assessed for blood pressure and glycohemoglobin measurements; functional performance (2-minute step test); anthropometric measurements (weight, height, and waist circumference); physical inactivity; alcohol consumption; smoking; and food consumption markers.
• A two-arm parallel cluster RCT will be conducted, with a baseline period of three months and a subsequent follow-up period of 12 months from the start of the intervention. To avoid possible contamination within the same primary care unit, randomization will take place at a primary care centre level: each centre will be randomized to the control or the intervention arm, rather than individual patients. Randomization will be performed by computer software and stratified by geographic location and municipality, to ensure balance between arms.
• At the end of the cluster-randomized controlled trial, another qualitative study will be carried out using the FG technique, in order to assess barriers and suggestions for improvement of each component of the implemented multidimensional strategy.

To calculate the sample size, the investigators took into account the proportion of patients with controlled hypertension (33%) and DM (37%) observed at baseline in the pilot study (data not published), and an absolute increase of 6% in these proportions one year after the implementation of the intervention, with a power of 0.80, level of significance of 0.05 and intra cluster correlation coefficient of 0.026. The calculated sample was 34 primary care centres, 17 in each arm, with a minimum of 148 participants in each centre. As the total number of primary care centres in the five municipalities is 35, the investigators planned to include one extra unit in the intervention arm. Taking into account a drop out rate of up to 17.8%, the total number of included individuals will be 180.

Inclusion criteria

Primary Health Care - Basic health unit with internet availability and complete team, including a Brazilian doctor or with a proficiency test in the Portuguese language.

Patients

• Adult patients (from 18 years-old), diagnosed with hypertension and/or DM, registered in the medical record.

Subproject cluster randomised controlled trial. All of the above criteria and the following additional criteria:

• Patients aged ≥ 18 years-old, with a diagnosis of hypertension and diabetes mellitus, registered in the medical record;
• Absence of contraindications to physical activity, according to the assistant physician's assessment;
• In intervention levels II and III, it will be a prerequisite that the participant has a smartphone.

Exclusion criteria

• Patients with terminal illness, with a life expectancy lower than 12 months according to the physician's evaluation.