A collaborative care psychosocial intervention for lowering blood pressure among old adults with hypertension and depression in primary care in Guarulhos, Brazil: the PROACTIVE-H study

INTERVENTION: The study is a two‐arm, cluster randomised controlled trial with Family Health Unit as the clusters and a 1:1 allocation ratio. This trial will be conducted in the city of Guarulhos, situated in the metropolitan region of São Paulo city, Brazil. Participants will be recruited from Family Health Units (FHU) which are primary healthcare units, where the Family Health Teams (FHT) provide healthcare assistance to the registered population. In this study, we will recruit 20 Family Health Units (FHU) with at least four FHT. Within each of these 20 FHU, four FHT will be randomly sampled, making a total of 80 FHT participating in our study. We will also recruit an additional 4 FHU as reserve, which will include a total of 16 FHU randomly sampled. For stratification, we will use the educational level information (percentage of individuals with no education or who had completed a literacy program for adults) collected through the electronic database (eSUS) of the 60 years or older individuals registered with each selected FHUs. Stratification will be into two sets of FHU (according to whether they are above or below the median on this educational variable). Thus, ten FHU will be allocated in each arm (five from each stratum). We aim to recruit 880 individuals 60 years or older registered with the selected FHTs. A list with all names and contact information of the individuals aged 59 years or over for each randomly selected FHT will be provided by the primary care administration of Guarulhos. Each participant will receive a random number when entering into the PROACTIVE database. Thus, a new list will be defined and the independent research assistant (RA) will contact the individuals according to this new order. Complete blinding of participants to trial allocation is impossible given the nature of this intervention. To decrease the risk of observer bias at follow‐up, the two assessments will be made by RAs who are not involve CONDITION: Hypertension and depression in older adults. ; Circulatory System PRIMARY OUTCOME: Difference in systolic blood pressure (SBP), measured using sphygmomanometer, between the two study arms eight months after baseline assessment. INCLUSION CRITERIA: 1. Individuals 60 years or older registered with the selected FHTs 2. 9‐item Patient Health Questionnaire (PHQ‐9) score 10 or above (threshold for depression) 3. Systolic blood pressure (SBP)=140mmHg or diastolic blood pressure (DBP) = 90 mmHg will be eligible for inclusion in the study. SECONDARY OUTCOME: ; 1. The maintenance of any earlier clinical gains regarding the SBP (proportion of participants that maintain the lower SBP) at 12 months.; The following additional secondary measures will be completed at 8 and 12 months and compared between the two arms:; 2. European Quality of Life five‐dimensional questionnaire, Five‐level version (EQ‐5D‐5L); 3. ICEpop CAPability measure for Older people (ICECAP‐O); 4. Behavioural Activation for Depression Scale (BADS); 5. Stressful life events (SLE); General Anxiety Disorder‐7 (GAD‐7); 6. Lubben Social Network Scale‐6 (LSNS‐6); 7. Alcohol Use Disorders Identification Test‐Consumption (AUDIT‐C); 8. Loneliness Scale (3‐item UCLA); 9. We will assess the cost‐effectiveness of the intervention at 12 months.;