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
Recruitment status was Recruiting
Sponsor:
Universidade de Blumenau
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
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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
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 Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on March 03, 2015