Intensification of Care to Improve Adherence to Anti-hypertensives

Medication Adherence Clinical Trial

— HyperCare  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01331369
• Other study ID #: FURB 2010/01
• Status: Completed
• Phase: N/A
• First received: March 29, 2011
• Last updated: April 8, 2017
• Start date: November 2010
• Est. completion date: April 2012

Study information

• Verified date: April 2017
• Source: Universidade de Blumenau
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 243
• Est. completion date: April 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Medication Adherence

Intervention

Behavioral:
• Intensification of Care
Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.

Other:
• Usual Care
Usual care provided (medical and/or nurse consultation and medicines)

Locations

Country	Name	City	State
Brazil	Family Health Units - Unique Health System	Blumenau	Santa Catarina

Sponsors (2)

Lead Sponsor	Collaborator
Universidade de Blumenau	Fundacao de Apoio a Pesquisa de Santa Catarina

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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

External Links

•   Research Group of Pharmacoepidemiology