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Completed

NCT Number: NCT01331369

Intensification of Care to Improve Adherence to Anti-hypertensives

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.

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Key information

Conditions

Medication Adherence Behavior Health Behavior Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Family Health Units - Unique Health System

Blumenau, Santa Catarina, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Comprehensive Care

Usual Care

Other

Usual care provided (medical and/or nurse consultation and medicines)

Other names: Usual

Primary outcomes

  1. 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

  1. Change in the proportion of people adherent to treatment - QAM-Q

    Time frame: 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..)

  2. Means difference and/or risk ratio between and within groups of clinical outcomes

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Universidade de Blumenau

Other

Collaborators

  • Fundacao de Apoio a Pesquisa de Santa Catarina

Registry information

Official study title

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

Acronym: HyperCare

Important dates

Study start
2010
Primary completion
2011
Study completion
2012
First posted
Apr 8, 2011
Registry last updated
Apr 11, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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