Intensification of Care to Improve Adherence to Anti-hypertensives

Study Overview
=================
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.

Official Title
-----------------
Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.

Conditions
-----------------
Medication Adherence

Intervention / Treatment
-----------------
* Behavioral: Intensification of Care
* Other: Usual Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>Usual care. It means routine medical care that include free demand consultation and free medicines. | Other: Usual Care<br>* Usual care provided (medical and/or nurse consultation and medicines)<br>* Other names: Usual;|
| Experimental: Intervention<br>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. | Behavioral: Intensification of Care<br>* Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.<br>* Other names: Comprehensive Care;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of people adherent to treatment - MMAS-8 | 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). | at basal and 3, 6, 9 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the proportion of people adherent to treatment - QAM-Q | 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..) | at basal and 3, 6, 9 and 12 months | 
| Means difference and/or risk ratio between and within groups of clinical outcomes | It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group. | at basal and 3, 6, 9 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
abandon, adherence, compliance, persistence, drop out