HypertensionNCT01834365
Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly
A study testing Structured education, Checklist and Without structure education with checklist in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
There is a structured educational effect on blood pressure reduction in elderly hypertensive patients. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hypertension
- What is being tested?
- Structured education, Checklist and Without structure education with checklist
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteIndonesia
- Study dates
- Oct 2012to May 2013
- 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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subject with age more than 60 years
- Blood pressure higher than 140/90
Who cannot join
- Severe Dementia
- Depression
- Malignant Hypertension
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Hospital Recruiting
Jakarta, 15111
About this study
Official title: Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial
There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.
Read the detailed description
Eligibility criteria are men and women over 60 years old and available to participate in the study for 3 months with blood pressure higher than 140/90.
Exclusion criteria are severe dementia, malignant hypertension, depression
Outcome measures are systolic and diastolic blood pressure after 3 months administration of structured education once a month.
- Conditions
- Hypertension
- Being tested
- Structured education, Checklist, Without structure education with checklist
- Keywords
- Hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured educationOther
Formatted education about hypertension
ChecklistOther
Without structure education with checklistOther
| Study group | Role | What they receive |
|---|---|---|
| Structured education & checklist | Experimental | Formatted education and checklist every month for 3 months Receives: Other: Structured education; Other: Checklist |
| Structured education | Active comparator | Formatted education every month for 3 months Receives: Other: Structured education |
| Without Structured Education with checklist | Active comparator | No structured education with checklist Receives: Other: Without structure education with checklist |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure
We aim to measure the difference in systolic blood pressure after 3 months administration structured education in elderly with hypertension
Measured: 3 Months
Secondary outcomes (1)
Diastolic blood pressure
We measure the difference of diastolic blood pressure after 3 Months administration of structured education in elderly with hypertension
Measured: 3 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2013 (estimated)
- Study startOct 2012
- Primary completionFeb 2013
- Study completionMay 2013 (estimated)
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.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayatullah Khomaini, MD, Universitas Indonesia
- Investigators
- Ayatullah Khomaini, MD, Principal investigator, Faculty of Medicine University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01834365
- Sponsor's protocol ID
- AKhomaini
- Status last verified
- Apr 2013
- First submitted
- 10 Apr 2013
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Structured Education to Decrease Blood Pressure for Hypertension in Elderly : a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01834365
- Acronym / sponsor ID
- AKhomaini
- Conditions
- Hypertension
- Keywords
- Hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- Oct 2012
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (estimated)
- First posted
- 17 Apr 2013 (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.
There is a structured educational effect on blood pressure reduction in elderly hypertensive patients.
Detailed description
Eligibility criteria are men and women over 60 years old and available to participate in the study for 3 months with blood pressure higher than 140/90.
Exclusion criteria are severe dementia, malignant hypertension, depression
Outcome measures are systolic and diastolic blood pressure after 3 months administration of structured education once a month.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Structured education & checklist | Experimental | Other: Structured education, Other: ChecklistFormatted education and checklist every month for 3 months |
| Structured education | Active comparator | Other: Structured educationFormatted education every month for 3 months |
| Without Structured Education with checklist | Active comparator | Other: Without structure education with checklistNo structured education with checklist |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Subject with age more than 60 years
- Blood pressure higher than 140/90
Key exclusion criteria (3 listed)
- Severe Dementia
- Depression
- Malignant Hypertension
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 |
|---|---|---|
| Structured educationFormatted education about hypertension | Other | Structured education, Structured education & checklist |
| Checklist | Other | Structured education & checklist |
| Without structure education with checklist | Other | Without Structured Education with checklist |
Primary outcome
Systolic blood pressure
Time frame: 3 Months
We aim to measure the difference in systolic blood pressure after 3 months administration structured education in elderly with hypertension
1 secondary outcome
Diastolic blood pressure
Time frame: 3 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
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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.
Ayatullah Khomaini, MD principal investigator
Faculty of Medicine University of Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Structured education, Checklist and Without structure education with checklist in people with Hypertension, run by Universitas Indonesia at 1 site in Indonesia.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Apr 2013. 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 Indonesia. 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?
Results are not available in the source record.
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?
Systolic blood pressure (time frame: 3 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 17 Apr 2013.