Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Medication Adherence
- Sponsor
- Universidade de Blumenau
- Enrollment
- 243
- Locations
- 1
- Primary Endpoint
- Change in the proportion of people adherent to treatment - MMAS-8
- Status
- Completed
- Last Updated
- 9 years ago
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.
Investigators
Ernani Tiaraju de Santa Helena
Professor
Universidade de Blumenau
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
Outcomes
Primary Outcomes
Change in the proportion of people adherent to treatment - MMAS-8
Time Frame: 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 Outcomes
- 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)