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
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Received Date ICMJE | March 29, 2011 | ||||||||
| Last Updated Date | April 7, 2011 | ||||||||
| Start Date ICMJE | November 2010 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
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). |
||||||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01331369 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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. |
||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Intensification of Care to Improve Adherence to Anti-hypertensives | ||||||||
| Official Title ICMJE | Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial. | ||||||||
| 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. |
||||||||
| 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. |
||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Health Services Research |
||||||||
| Condition ICMJE | Medication Adherence | ||||||||
| Intervention ICMJE |
|
||||||||
| Study Arm (s) |
|
||||||||
| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 396 | ||||||||
| Estimated Completion Date | April 2012 | ||||||||
| Estimated Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||||||
| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
|
||||||||
| Location Countries ICMJE | Brazil | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01331369 | ||||||||
| Other Study ID Numbers ICMJE | FURB 2010/01 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Ernani Tiaraju de Santa Helena, Universidade Regional de Blumenau | ||||||||
| Study Sponsor ICMJE | Universidade de Blumenau | ||||||||
| Collaborators ICMJE | Fundacao de Apoio a Pesquisa de Santa Catarina | ||||||||
| Investigators ICMJE |
|
||||||||
| Information Provided By | Universidade de Blumenau | ||||||||
| Verification Date | November 2010 | ||||||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||||||