Medication Adherence
Conditions
Keywords
adherence, compliance, persistence, drop out, abandon
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.
Interventions
BEHAVIORALIntensification of Care
Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
OTHERUsual Care
Usual care provided (medical and/or nurse consultation and medicines)
Sponsors
Fundacao de Apoio a Pesquisa de Santa Catarina
Universidade de Blumenau
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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..) |
| 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. |
Countries
Brazil
Outcome results
None listed