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

This study has been completed.

Sponsor:

Collaborator:

Fundacao de Apoio a Pesquisa de Santa Catarina

Information provided by (Responsible Party):

Ernani Tiaraju de Santa Helena, Universidade de Blumenau

ClinicalTrials.gov Identifier:

NCT01331369

First received: March 29, 2011

Last updated: April 8, 2017

Last verified: April 2017

History of Changes

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 Intervention Model: Parallel Assignment Masking: No masking Primary Purpose: Health Services Research
Official Title:	Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.

Further study details as provided by Ernani Tiaraju de Santa Helena, Universidade de Blumenau:

Primary Outcome Measures:

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 Outcome Measures:

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.


Enrollment:	243
Study Start Date:	November 2010
Study Completion Date:	April 2012
Primary Completion Date:	December 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Control Usual care. It means routine medical care that include free demand consultation and free medicines.	Other: Usual Care Usual care provided (medical and/or nurse consultation and medicines) Other Name: Usual
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.	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 (Adult, Senior)
Sexes Eligible for Study:	All
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

Locations


Brazil
Family Health Units - Unique Health System
Blumenau, Santa Catarina, Brazil

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:

Research Group of Pharmacoepidemiology This link exits the ClinicalTrials.gov site


Responsible Party:	Ernani Tiaraju de Santa Helena, Professor, Universidade 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 8, 2017

Keywords provided by Ernani Tiaraju de Santa Helena, Universidade de Blumenau:


adherence compliance persistence drop out abandon

Additional relevant MeSH terms:


Antihypertensive Agents

ClinicalTrials.gov processed this record on July 24, 2017

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