Intensification of Care to Improve Adherence to Anti-hypertensives

Not Applicable

Completed

• Conditions: Medication Adherence
• Interventions: Other: Usual Care; Behavioral: Intensification of Care

• Registration Number: NCT01331369
• Lead Sponsor: Universidade de Blumenau

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2010-11
• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-04-07
• Study First Posted: 2011-04-08
• Primary Completion: 2011-12
• Study Completion: 2012-04
• Status Verified: 2017-04
• Last Update Submitted: 2017-04-08
• Last Update Posted: 2017-04-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Usual Care	Usual care. It means routine medical care that include free demand consultation and free medicines.
Intervention	Intensification of Care	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.

Primary Outcome Measures

Name	Time	Method
Change in the proportion of people adherent to treatment - MMAS-8	at basal and 3, 6, 9 and 12 months	It will be measure by "Moriski Medication Adherence Scale 8 item", translated and validated in Brazil. MMAS scores were trichotomized previously into the following 3 levels of adherence: high adherence (score, 8), medium adherence (score, 6 to \<8), and low adherence (score, \<6).

Secondary Outcome Measures

Name	Time	Method
Means difference and/or risk ratio between and within groups of clinical outcomes	at basal and 3, 6, 9 and 12 months	It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.
Change in the proportion of people adherent to treatment - QAM-Q	at basal and 3, 6, 9 and 12 months	It will be measure by "Questionário de Adesão a Medicamentos -Qualiaids" 3 item, an structured questionnaire developed and validated in Brazil. Non-adherence was accepted if respondent doesn't take 80% of his medicines or if he/she presents any errors on the process (time, jumps..)

Trial Locations

Locations (1)

Family Health Units - Unique Health System; 🇧🇷 Blumenau, Santa Catarina, Brazil