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

Not Applicable

• Conditions: Hypertension and depression in older adults.; Circulatory System

• Registration Number: ISRCTN16601130
• Lead Sponsor: Faculdade de Medicina da Universidade de São Paulo

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-05-03
• Study Completion: 2020-05-31
• Last Update Posted: 22 August 2022

Recruitment & Eligibility

• Status: Stopped
• Sex: All
• Target Recruitment: 880

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<br> 1. The maintenance of any earlier clinical gains regarding the SBP (proportion of participants that maintain the lower SBP) at 12 months.<br> The following additional secondary measures will be completed at 8 and 12 months and compared between the two arms:<br> 2. European Quality of Life five-dimensional questionnaire, Five-level version (EQ-5D-5L)<br> 3. ICEpop CAPability measure for Older people (ICECAP-O)<br> 4. Behavioural Activation for Depression Scale (BADS)<br> 5. Stressful life events (SLE); General Anxiety Disorder-7 (GAD-7)<br> 6. Lubben Social Network Scale-6 (LSNS-6)<br> 7. Alcohol Use Disorders Identification Test-Consumption (AUDIT-C)<br> 8. Loneliness Scale (3-item UCLA)<br> 9. We will assess the cost-effectiveness of the intervention at 12 months.<br>