HypertensionPHPTCHPNCT02036814
Program for Health Promotion to Improve Therapeutic Compliance in Hypertensive Patiente
A study testing Program Health Education in people with Hypertension, run by University of Sao Paulo General Hospital.
Trial summary
The aim was to test if interpersonal relationships group strategies provided by nursing can promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in hypertensive patients. Read more about this study
- Who is it for?
- Ages 25 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Program Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- No sites listed yet
- Study dates
- Mar 2007to Feb 2011
- 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 25 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Hypertensive patients under treatment regimen;
- Pressure levels greater than or equal to 90 mmHg diastolic blood pressure (DBP), and
- Pressure level greater than or equal to 140 mmHg systolic blood pressure (SBP)
- Age limit between 25 to 75 years, for both female and male.
Who cannot join
- Diabetes patients
About this study
Official title: A PROGRAM OF HEALTH EDUCATION PROMOTION BY NURSING CAN IMPROVE BLOOD PRESSURE CONTROL AND QUALITY OF LIFE IN HYPERTENSIVE PATIENTS?
The aim was to test if interpersonal relationships group strategies provided by nursing can promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A 10 patients (8 women), underwent to a health educational orientation program (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings). Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days during 4 months (3 meetings). Both groups received the same content guidelines (healthy lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30 days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120 days.
- Conditions
- Hypertension
- Being tested
- Program Health Education
- Keywords
- Hypertension, Nursing, Therapeutic compliance, Quality of life, Health education
- Medical subject headings
- Hypertension, Patient Compliance, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Program Health EducationBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group A who underwent to an inter-relational strategy | Experimental | Group A who underwent to a health educational orientation program (inter-relational strategy) Receives: Behavioral: Program Health Education |
| Group B who underwent group orientation by the nurse | Experimental | Not described Receives: Behavioral: Program Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
measure blood pressure arterial
At the first nurse interview (day 0: randomization) three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.Ambulatory BP monitoring was recorded at 15 and 180 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at night
Measured: 4 months
Secondary outcomes (1)
QoL questionnaire (WHOQoL-Brief)
At the first nurse interview (day 0: randomization), a questionnaire was used to obtain information related to general data, habits, history of disease, other risk factors for cardiovascular disease, and prescribed medications. This questionnaire was used only to characterize the adherence behavior and the risk factors at the beginning the study, but was not used to evaluate modifications of behavior during the study.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2014 (estimated)
- Study startMar 2007
- Primary completionMar 2008
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- InCor Heart Institute
- Responsible party
- Principal investigator, Grazia Maria Guerra, University of Sao Paulo General Hospital
- Investigators
- Heno Ferreira Lopes, PhD, Study chair, Heart Institute of Medicine School of University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02036814
- Sponsor's protocol ID
- CAPPesq779/05
- Acronym
- PHPTCHP
- Status last verified
- Jan 2014
- First submitted
- 11 Oct 2013
- Last updated
- 15 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A PROGRAM OF HEALTH EDUCATION PROMOTION BY NURSING CAN IMPROVE BLOOD PRESSURE CONTROL AND QUALITY OF LIFE IN HYPERTENSIVE PATIENTS?
- ClinicalTrials.gov ID
- NCT02036814
- Acronym / sponsor ID
- PHPTCHP / CAPPesq779/05
- Conditions
- Hypertension
- Keywords
- Hypertension, Nursing, Therapeutic compliance, Quality of life, Health education
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- InCor Heart Institute
- Study start
- Mar 2007
- Primary completion
- Mar 2008 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 15 Jan 2014 (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 was to test if interpersonal relationships group strategies provided by nursing can promote an additional benefit on blood pressure (BP) control and quality of life (QoL) in hypertensive patients. Methods: 21 treated patients were randomized into two groups: Group A 10 patients (8 women), underwent to a health educational orientation program (inter-relational strategy), with group meetings every 15 days during 4 months(8 meetings). Group B 11 patients (7 women), who underwent group orientation by the nurse every 40 days during 4 months (3 meetings). Both groups received the same content guidelines (healthy lifestyle and prevention of risk factors). The patients had 2 visits by nurses at baseline (15 days) and at the final study (120 days). BP was measured by auscultatory method and QoL questionnaire (WHOQoL-Brief)was applied. The dispensing and pill counts were done every 30 days. Ambulatory blood pressure monitoring (ABPM) was performed at baseline and after 120 days.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A who underwent to an inter-relational strategy | Experimental | Behavioral: Program Health EducationGroup A who underwent to a health educational orientation program (inter-relational strategy) |
| Group B who underwent group orientation by the nurse | Experimental | Behavioral: Program Health Education |
Who may qualify
- Ages
- 25 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Hypertensive patients under treatment regimen;
- Pressure levels greater than or equal to 90 mmHg diastolic blood pressure (DBP), and
- Pressure level greater than or equal to 140 mmHg systolic blood pressure (SBP)
- Age limit between 25 to 75 years, for both female and male.
Key exclusion criteria (1 listed)
- Diabetes patients
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 |
|---|---|---|
| Program Health Education | Behavioural | Group A who underwent to an inter-relational strategy, Group B who underwent group orientation by the nurse |
Primary outcome
measure blood pressure arterial
Time frame: 4 months
At the first nurse interview (day 0: randomization) three consecutive measurements of BP were taken after the patient had rested for 5 min in the supine position.Ambulatory BP monitoring was recorded at 15 and 180 days of follow-up for 24 h with a noninvasive ABPM (Space Labs 90207 monitor; Space Labs, Redmond, WA) with an appropriate-sized cuff. The monitor was placed on the nondominant arm and was set to take BP readings every 10 min during the day and every 20 min at night
1 secondary outcome
QoL questionnaire (WHOQoL-Brief)
Time frame: 4 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 15 Jan 2014.
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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.
Heno Ferreira Lopes, PhD study chair
Heart Institute of Medicine School of University of São Paulo
Questions about this trial
What is this clinical trial studying?
A study testing Program Health Education in people with Hypertension, run by University of Sao Paulo General Hospital.
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 4 inclusion and 1 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 15 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
measure blood pressure arterial (time frame: 4 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 15 Jan 2014.