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Intensification of Care to Improve Adherence to Anti-hypertensives (HyperCare)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01331369
First Posted: April 8, 2011
Last Update Posted: April 11, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Fundacao de Apoio a Pesquisa de Santa Catarina
Information provided by (Responsible Party):
Ernani Tiaraju de Santa Helena, Universidade de Blumenau
March 29, 2011
April 8, 2011
April 11, 2017
November 2010
December 2011   (Final data collection date for primary outcome measure)
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).
Means difference and risk ratio between and within groups of adherence to treatment [ Time Frame: at basal and 3, 6, 9 and 12 months ]
It will be evaluated by two methods: pill count (proportion of pill taken as prescribed) and self-report using a structured validated questionnaire (proportion adherents in each group).
Complete list of historical versions of study NCT01331369 on ClinicalTrials.gov Archive Site
  • 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..)
  • 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.
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.
Not Provided
Not Provided
 
Intensification of Care to Improve Adherence to Anti-hypertensives
Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Medication Adherence
  • 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 Name: Comprehensive Care
  • Other: Usual Care
    Usual care provided (medical and/or nurse consultation and medicines)
    Other Name: Usual
  • Active Comparator: Control
    Usual care. It means routine medical care that include free demand consultation and free medicines.
    Intervention: Other: Usual Care
  • Experimental: Intervention
    Intensification of care. Besides routine medical care that include free demand consultation and free medicines, subjects were invited to have 6 structured medical encounters based on a social-psychological approach. Doctors must follow a protocol to conduct the encounter that have around 30 minutes each.
    Intervention: Behavioral: Intensification of Care
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
243
April 2012
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
 
NCT01331369
FURB 2010/01
No
Not Provided
Not Provided
Ernani Tiaraju de Santa Helena, Universidade de Blumenau
Universidade de Blumenau
Fundacao de Apoio a Pesquisa de Santa Catarina
Principal Investigator: Ernani S Helena, PhD Regional University of Blumenau
Universidade de Blumenau
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP