Intensification of Care to Improve Adherence to Anti-hypertensives

NCT01331369 | Completed

• 1 other identifier: FURB 2010/01
• Study Type: interventional
• Target: 243
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Medication Adherence

Keywords

adherence; compliance; persistence; drop out; abandon

Outcome Measures

Primary Outcomes (1)

• Change in the proportion of people adherent to treatment - MMAS-8

  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).

  at basal and 3, 6, 9 and 12 months

Secondary Outcomes (2)

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

  at basal and 3, 6, 9 and 12 months

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

  at basal and 3, 6, 9 and 12 months

Study Arms (2)

Control

ACTIVE COMPARATOR

Usual care. It means routine medical care that include free demand consultation and free medicines.

Other: Usual Care

Intervention

EXPERIMENTAL

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

Interventions

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.

Also known as: Comprehensive Care

Intervention

Usual Care OTHER

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

Also known as: Usual

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• persons with hypertension aged 18 years and older

You may not qualify if:

• those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
• pregnants

Sponsors & Collaborators

• Universidade de Blumenau: lead
• Fundacao de Apoio a Pesquisa de Santa Catarina: collaborator

Study Sites (1)

Family Health Units - Unique Health System

Blumenau, Santa Catarina, Brazil

Location

Related Links

• Research Group of Pharmacoepidemiology

MeSH Terms

Conditions

Medication Adherence; Patient Compliance

Interventions

Comprehensive Health Care

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Patient Care Management; Health Services Administration

Study Officials

• Ernani S Helena, PhD

  Regional University of Blumenau

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 29, 2011
• First Posted: April 8, 2011
• Study Start: November 1, 2010
• Primary Completion: December 1, 2011
• Study Completion: April 1, 2012
• Last Updated: April 11, 2017

Record last verified: 2017-04

Locations

BR (1)