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| Name | Class |
|---|---|
| Fundacao de Apoio a Pesquisa de Santa Catarina | UNKNOWN |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Active Comparator | Usual care. It means routine medical care that include free demand consultation and free medicines. |
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| Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intensification of Care | Behavioral | Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ernani S Helena, PhD | Regional University of Blumenau | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Family Health Units - Unique Health System | Blumenau | Santa Catarina | Brazil |
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| Label | URL |
|---|---|
| Research Group of Pharmacoepidemiology | View source |
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| ID | Term |
|---|---|
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D003191 | Comprehensive Health Care |
| ID | Term |
|---|---|
| D010346 | Patient Care Management |
| D006298 | Health Services Administration |
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| Usual Care | Other | Usual care provided (medical and/or nurse consultation and medicines) |
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| 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 |