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

A collaborative care psychosocial intervention for lowering blood pressure among old adults with hypertension and depression within the Family Health Strategy in Guarulhos, Brazil: the PROACTIVE-H cluster randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN16601130

Enrollment

880

Registered

2019-05-03

Start date

2019-05-06

Completion date

Unknown

Last updated

2022-08-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension and depression in older adults. Circulatory System

Interventions

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 m

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

Exclusion criteria: 1. Partner or another person that lives in the same household has already been included in the study 2. Acute suicidal risk in response to the PHQ-9 and the additional suicidal risk questionnaire 3. Completely deaf 4. Unable to communicate (non-native speaker, cognitive impairment and psychotic symptoms) 5. Unable to engage in the trial for the period of 12 months (terminal illness, partner with terminal illness, plans to move out to another area)

Design outcomes

Primary

Measure	Time frame
Difference in systolic blood pressure (SBP), measured using sphygmomanometer, between the two study arms eight months after baseline assessment.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Countries

Brazil

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026