Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)

Universidade de Blumenau

Status: Completed

Conditions: Medication Adherence

Treatments: Other: Usual Care; Behavioral: Intensification of Care

Study type: Interventional

Funder types: Other

Identifiers

NCT01331369

FURB 2010/01

Details and patient eligibility

About

The aim of the study is to evaluate the effectiveness of a social-psychological intervention to improve anti-hypertensives adherence in primary care. Its is a pragmatic clinical trial.

Full description

We will study two groups of 198 people with hypertension treated in ten health care units. One group will receive usual care dispensed in units (control). The other group (intervention) will be offered six individual assistance with health care worker physician or nurse) during the period of 9 months with a minimum interval of 30 days, plus 9 monthly visits structured by community health agents. Adherence will be measured in both groups at baseline and months 3, 6, 9 and 12, through validated questionnaire and pill count. Also evaluated clinical outcome measures (blood pressure, hospitalizations and deaths). The analysis will be done by intention to treat comparing adherence measures and clinical outcome between groups (Student t test and chi-square test) and within groups over time (paired t test and McNemar). It will be accepted p value <0.05.

Enrollment: 243 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• persons with hypertension aged 18 years and older

Exclusion criteria

• those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
• pregnants

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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243 participants in 2 patient groups

Control

Active Comparator group

Description:

Usual care. It means routine medical care that include free demand consultation and free medicines.

Treatment:

Other: Usual Care

Intervention

Experimental group

Description:

Intensification of care. Besides routine medical care that include free demand consultation and free medicines, subjects were invited to have 6 structured medical encounters based on a social-psychological approach. Doctors must follow a protocol to conduct the encounter that have around 30 minutes each.

Treatment:

Behavioral: Intensification of Care