Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 243
- 试验地点
- 1
- 主要终点
- Change in the proportion of people adherent to treatment - MMAS-8
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •persons with hypertension aged 18 years and older
排除标准
- •those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
- •pregnants
结局指标
主要结局
Change in the proportion of people adherent to treatment - MMAS-8
时间窗: 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).
次要结局
- Means difference and/or risk ratio between and within groups of clinical outcomes(at basal and 3, 6, 9 and 12 months)
- Change in the proportion of people adherent to treatment - QAM-Q(at basal and 3, 6, 9 and 12 months)
研究者
Ernani Tiaraju de Santa Helena
Professor
Universidade de Blumenau
