Clinical trial NCT05660928: Control of Hypertension and diAbetes in MINas Gerais
Official title: Control of Hypertension and diAbetes in MINas Gerais: Assessment of the Impact of Implementing a Multidimensional Strategy for Management of Patients With Systemic Arterial Hypertension and Diabetes Mellitus in Primary Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Arterial Hypertension
Diabetes Mellitus
Keywords: Hypertension
Diabetes mellitus
Telemedicine
Primary health care
Lead sponsor: Federal University of Minas Gerais
Sponsor class: OTHER
Collaborators: name: Federal University of the Valleys of Jequitinhonha and Mucuri
name: Medical Research Council
name: University of Southampton
First posted: 2022-12-21
Enrollment: 5132
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized controlled trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Hypertension and diabetes mellitus (DM) are highly prevalent in low and middle-income countries, and the proportion of patients with uncontrolled diseases is higher than in high income countries. Innovative strategies are required to surpass barriers of low sources, distance, and quality of healthcare. Our aim is to assess the uptake and effectiveness of the implementation of an integrated multidimensional strategy in the primary care setting, for the management of patients with hypertension and diabetes mellitus (DM) in Brazil. This is a scale up implementation study that has mixed-methods, and comprehends four steps: (1) needs assessment, including a standardized structured questionnaire and focus groups with healthcare practitioners; (2) baseline period, three months before the implementation of the intervention; (3) cluster randomized controlled trial (RCT) with a 12-month follow-up period; and (4) a qualitative study after the end of follow-up. The cluster RCT will randomize 35 centres to intervention (n= 18) or usual care (n= 17). Patients ≥18 years-old, with diagnosis of hypertension and/or DM, of five Brazilian cities in a resource-constrained area will be enrolled. The intervention consists of a multifaceted strategy, with a multidisciplinary approach, including telehealth tools (decision support systems, short message service, telediagnosis), continued education with an approach to issues related to the care of people with hypertension and diabetes in primary care, including pharmacological and non-pharmacological treatment and behavioural change. The project has actions focused on professionals and patients.

Detailed description: 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.

1. 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.
2. 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.
3. 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.
4. 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Composite outcome of proportion of patients with controlled disease
timeFrame: 12 months
Secondary outcomes:
measure: Proportion of patients with controlled hypertension
timeFrame: 12 months
measure: Proportion of patients with controlled diabetes
timeFrame: 12 months
measure: Change in blood pressure
timeFrame: 12 months
measure: Change in glycohemoglobin
timeFrame: 12 months
measure: Number of blood pressure measurements
timeFrame: 12 months
measure: Number of glycohemoglobin measurements
timeFrame: 12 months
Other outcomes:
measure: Percentage of patients who participated in group activities in 12 months.
timeFrame: 12 months
measure: Total follow-up time of patients
timeFrame: 12 months
measure: Number of consultations during the follow-up time
timeFrame: 12 months
measure: Performance in the 2-minute standing gait test
timeFrame: 6 and 12 months
measure: Performance in the hand grip strength test
timeFrame: 6 and 12 months
measure: Change in the body weight
timeFrame: 12 months
measure: Change in the body mass index
timeFrame: 12 months
measure: Change in the waist circumference
timeFrame: 12 months
measure: Program adherence
timeFrame: 12 months
Locations:
city: Belo Horizonte
country: Brazil
facility: Federal University of Minas Gerais
state: Minas Gerais
Study officials:
References: