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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2010 by Universidade de Blumenau.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Fundacao de Apoio a Pesquisa de Santa Catarina
Information provided by:
Universidade de Blumenau
ClinicalTrials.gov Identifier:
NCT01331369
First received: March 29, 2011
Last updated: April 7, 2011
Last verified: November 2010

March 29, 2011
April 7, 2011
November 2010
December 2011   (final data collection date for primary outcome measure)
Means difference and risk ratio between and within groups of adherence to treatment [ Time Frame: at basal and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
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).
Same as current
Complete list of historical versions of study NCT01331369 on ClinicalTrials.gov Archive Site
Means difference and/or risk ratio between and within groups of clinical outcomes [ Time Frame: at basal and 3, 6, 9 and 12 months ] [ Designated as safety issue: No ]
It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.
Same as current
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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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 provided care
    Intervention: Other: Usual Care
  • Experimental: Intervention
    Social-psychological interventions
    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.
 
Recruiting
396
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
Both
18 Years and older
No
Contact: Ernani S Helena, PhD 55 47 3321 0610 erntsh@furb.br
Contact: Nevoni G Damo, MSc 55 47 3321 0610 nevoni@furb.br
Brazil
 
NCT01331369
FURB 2010/01
No
Ernani Tiaraju de Santa Helena, Universidade Regional 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
November 2010

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