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
  Purpose

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.


Condition Intervention
Medication Adherence
Behavioral: Intensification of Care
Other: Usual Care

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.

Resource links provided by NLM:


Further study details as provided by Universidade de Blumenau:

Primary Outcome Measures:
  • 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).


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 396
Study Start Date: November 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Control
Usual provided care
Other: Usual Care
Usual care provided (medical and/or nurse consultation and medicines)
Other Name: Usual
Experimental: Intervention
Social-psychological interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01331369

Contacts
Contact: Ernani S Helena, PhD 55 47 3321 0610 erntsh@furb.br
Contact: Nevoni G Damo, MSc 55 47 3321 0610 nevoni@furb.br

Locations
Brazil
Family Health Units - Unique Health System Recruiting
Blumenau, Santa Catarina, Brazil
Contact: Sheila Santos, MSc       gerenciafarmaceutica@blumenau.sc.gov.br   
Sponsors and Collaborators
Universidade de Blumenau
Fundacao de Apoio a Pesquisa de Santa Catarina
Investigators
Principal Investigator: Ernani S Helena, PhD Regional University of Blumenau
  More Information

Additional Information:
No publications provided

Responsible Party: Ernani Tiaraju de Santa Helena, Universidade Regional de Blumenau
ClinicalTrials.gov Identifier: NCT01331369     History of Changes
Other Study ID Numbers: FURB 2010/01
Study First Received: March 29, 2011
Last Updated: April 7, 2011
Health Authority: Brazil: Ministry of Health

Keywords provided by Universidade de Blumenau:
adherence
compliance
persistence
drop out
abandon

Additional relevant MeSH terms:
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 20, 2014