Medication AdherenceHyperCareNCT01331369
Intensification of Care to Improve Adherence to Anti-hypertensives
A study testing Intensification of Care in people with Medication Adherence, run by Universidade de Blumenau at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence
- What is being tested?
- Intensification of Care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 243 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2010to Apr 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- persons with hypertension aged 18 years and older
Who cannot join
- those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
- pregnants
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Family Health Units - Unique Health System
Blumenau, Santa Catarina
About this study
Official title: Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
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.
Read the 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.
- Conditions
- Medication Adherence
- Being tested
- Intensification of Care, Usual Care
- Keywords
- adherence, compliance, persistence, drop out, abandon
- Medical subject headings
- Medication Adherence, Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensification of CareBehavioural
Also called Comprehensive Care
Usual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol.
Usual CareOther
Also called Usual
Usual care provided (medical and/or nurse consultation and medicines)
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Usual care. It means routine medical care that include free demand consultation and free medicines. Receives: 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. Receives: Behavioral: Intensification of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: at basal and 3, 6, 9 and 12 months
Secondary outcomes (2)
Change in the proportion of people adherent to treatment - QAM-Q
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..)
Measured: at basal and 3, 6, 9 and 12 months
Means difference and/or risk ratio between and within groups of clinical outcomes
It will be evaluated mean blood pressure, proportion of complications, hospitalization and death in each group.
Measured: at basal and 3, 6, 9 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2011 (estimated)
- Study startNov 2010
- Primary completionDec 2011
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 243 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade de Blumenau
- Sponsor type
- University, hospital or other
- Collaborators
- Fundacao de Apoio a Pesquisa de Santa Catarina
- Responsible party
- Principal investigator, Ernani Tiaraju de Santa Helena, Universidade de Blumenau
- Investigators
- Ernani S Helena, PhD, Principal investigator, Regional University of Blumenau
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01331369
- Sponsor's protocol ID
- FURB 2010/01
- Acronym
- HyperCare
- Status last verified
- Apr 2017
- First submitted
- 29 Mar 2011
- Last updated
- 11 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intensification of Care to Improve Adherence to Anti-hypertensives in Primary Care: a Pragmatic Clinical Trial.
- ClinicalTrials.gov ID
- NCT01331369
- Acronym / sponsor ID
- HyperCare / FURB 2010/01
- Conditions
- Medication Adherence
- Keywords
- adherence, compliance, persistence, drop out, abandon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 243 participants (actual)
- Lead sponsor
- Universidade de BlumenauUniversity, hospital or other
- Collaborators
- Fundacao de Apoio a Pesquisa de Santa Catarina
- Study start
- Nov 2010
- Primary completion
- Dec 2011 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 8 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Other: Usual CareUsual care. It means routine medical care that include free demand consultation and free medicines. |
| Intervention | Experimental | Behavioral: Intensification of CareIntensification 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- persons with hypertension aged 18 years and older
Key exclusion criteria (2 listed)
- those with physical or mental impaired that cannot go to health care units or cannot answer a questionnaire
- pregnants
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intensification of CareAlso: Comprehensive CareUsual provided care plus social-psychological intervention: 6 consultation with doctors and 9 with community health workers, both oriented by protocol. | Behavioural | Intervention |
| Usual CareAlso: UsualUsual care provided (medical and/or nurse consultation and medicines) | Other | Control |
Primary outcome
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).
2 secondary outcomes
Change in the proportion of people adherent to treatment - QAM-Q
Time frame: at basal and 3, 6, 9 and 12 months
Means difference and/or risk ratio between and within groups of clinical outcomes
Time frame: at basal and 3, 6, 9 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2017.
- Research Group of PharmacoepidemiologyLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernani S Helena, PhD principal investigator
Regional University of Blumenau
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensification of Care in people with Medication Adherence, run by Universidade de Blumenau at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the proportion of people adherent to treatment - MMAS-8 (time frame: at basal and 3, 6, 9 and 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2017.