Essential HypertensionNCT05390931
Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes
A study testing 6-session motivational interviews, Health education structured according to the health belief model and Training booklet prepared by the researchers on healthy lifestyle behavior changes in people with Essential Hypertension and Motivational Interview, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
Trial summary
The primary aim of this study is to determine the effects of education and motivational interviews structured according to the health belief model on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis. Read more about this study
- Who is it for?
- Ages 30 to 59 years
- Conditions the study is for
- Essential Hypertension, Motivational Interview, Cardiovascular Disease Risk
- What is being tested?
- 6-session motivational interviews, Health education structured according to the health belief model and Training booklet prepared by the researchers on healthy lifestyle behavior changes
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2022to 31 Mar 2023
- 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 30 to 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Volunteer to participate in the research
- Those who are registered with any of the family physicians in the Family Health Center where the research will be conducted.
- Being in the age range of 30-59
- Having a physician-diagnosed essential hypertension
- Having estimated 10-year CHD risk ≥ 10% based on the Framingham risk score
- Being a literate
Who cannot join
- Having a disease like coronary artery disease, heart failure, angina, myocardial infarction, cerebrovascular diseases, cancer, or kidney failure.
- Having a pacemaker
- Having a disease like chronic obstructive pulmonary disease, neurological disorder, or psychosis and schizophrenia with severe mental illness
- Has a learning disability or communication disability
- Being pregnant
- Being morbid obese (BMI ≥50 kg/m2)
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Işıklar Family Health Center
Eskişehir, Tepebaşı, 26120
About this study
Official title: The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study
The primary aim of this study is to determine the effects of education and motivational interviews structured according to the health belief model on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis. The secondary aim of the study is to determine the effects of the variables that mediate the probability of performing primary prevention measures according to the health belief model of patients with a diagnosis of essential hypertension. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 6-month follow-up period. The research will be carried out at Işıklar Family Health Center located in Eskişehir city center in Turkey. The study population of this research consists of 659 patients with a diagnosis of essential hypertension, aged between 30-59 years, registered in Işıklar Family Health Center. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 80 individuals, 40 in each group, with an increase of 20%, will form the research group. The research data collection process will be carried out in 4 stages. First of all, the data required to query the inclusion criteria and exclusion criteria for participant admission to the study will be evaluated using the "Data form for participant admission". For the other stages of the research data collection process; "Pre-test (Beginning at 0 months)", "Intermediate follow-up test (Follow-up at 3 months)" and "Posttest (6 months)" will be administered to the participants in the study and control groups by the researcher. In this study, "Cardiovascular Disease Risk Awareness Assessment Scale", "Cardiovascular Diseases Risk Factors Knowledge Level", "Framingham Cardiovascular Risk Score", "Healthy Lifestyle Behaviors Scale-II", "Hypertension Self-Care Profile", "Hill- Bone Hypertension Treatment Adherence Scale", "Physical Activity Questionnaire for Primary Care" and "SF-12 Quality of Life Scale" will be used as data collection tools. In addition to their routine care, the control group will be given a health education structured according to the health belief model and a training booklet on healthy lifestyle behavior changes at the end of the training.
Read the detailed description
Hypertension plays an important role in the early death of 1 in 4 men and 1 in 5 women (more than one billion people) diagnosed with hypertension worldwide. Hypertension, the prevalence which can vary from country to country, is around 30-45% of the general population, and this rate is observed to increase with age, which will continue to be an important public health problem today and in the future. Worldwide, only one out of every 5 adults (about 21%) has hypertension under control. It is seen that the risk of cardiovascular morbidity and mortality is higher in patients whose blood pressure cannot be controlled. It is important to control hypertension in order to prevent cardiovascular diseases (CVD), also patients should comply with their treatment and health recommendations.
Motivational interviewing is a client-centered communication technique that reveals the behavior change and desire for change by helping the person to understand the problem or problems arising from himself, to discover the problem, to discover and solve the ambivalence.In this study, it is thought that motivational interviews structured according to the health belief model can be effective on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis.
- Conditions
- Essential Hypertension, Motivational Interview, Cardiovascular Disease Risk, Healthy Lifestyle Behavior
- Being tested
- 6-session motivational interviews, Health education structured according to the health belief model, Training booklet prepared by the researchers on healthy lifestyle behavior changes, 6 month follow-up
- Medical subject headings
- Essential Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6-session motivational interviewsBehavioural
A total of 6 motivational interviews will be held once a month. Motivational interviews will be conducted individually.
Health education structured according to the health belief modelOther
After the participants enrolled in the study, the patients in the study group will be given a health education structured according to the health belief model at the first interview.
Training booklet prepared by the researchers on healthy lifestyle behavior changesOther
After the participants enrolled in the study and take health education, a training booklet prepared by the researchers on healthy lifestyle behavior changes will be given to the participants.
6 month follow-upOther
Follow-ups will be made 3 times in total, on the basis of pre-test, intermediate follow-up test (3 months), and post-test (6 months).
| Study group | Role | What they receive |
|---|---|---|
| Study group | Experimental | Study group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up. Receives: Behavioral: 6-session motivational interviews; Other: Health education structured according to the health belief model; Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes; Other: 6 month follow-up |
| Control group | Other | Control group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up. Receives: Other: Health education structured according to the health belief model; Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes; Other: 6 month follow-up |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
Systolic and diastolic blood pressure
Measured: 3rd month
Change from Baseline Systolic and Diastolic Blood Pressure at 6 months
Systolic and diastolic blood pressure
Measured: 6th month
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
Measured: 3rd month
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
Measured: 6th month
Change from Baseline Healthy Lifestyle Behaviors at 6 months
"Healthy Lifestyle Behaviors Scale II" will be used to determine the healthy lifestyle behavior changes of the participants. A minimum of 52 and a maximum of 208 points can be obtained from the scale. Increasing scores from the scale indicate that individuals develop positive healthy lifestyle behaviors.
Measured: 6th month
Secondary outcomes (8)
Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months
The "Cardiovascular Disease Risk Awareness Assessment Scale" will be used to evaluate the awareness of individuals with a diagnosis of essential hypertension about the risks associated with cardiovascular diseases. A minimum of 14 and a maximum of 56 points can be obtained from the scale. The higher scores obtained from the scale, the higher the awareness of cardiovascular diseases.
Measured: 3rd month
Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months
The "Cardiovascular Disease Risk Awareness Assessment Scale" will be used to evaluate the awareness of individuals with a diagnosis of essential hypertension about the risks associated with cardiovascular diseases. A minimum of 14 and a maximum of 56 points can be obtained from the scale. The higher scores obtained from the scale, the higher the awareness of cardiovascular diseases.
Measured: 6th month
Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months
"Cardiovascular Diseases Risk Factors Knowledge Level" will be used to determine the knowledge level of the participants on cardiovascular disease risk factors. The highest total score that can be obtained from the scale is 28, and the higher score, the higher the level of knowledge.
Measured: 3rd month
Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months
"Cardiovascular Diseases Risk Factors Knowledge Level" will be used to determine the knowledge level of the participants on cardiovascular disease risk factors. The highest total score that can be obtained from the scale is 28, and the higher score, the higher the level of knowledge.
Measured: 6th month
Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months
The "Hypertension Self-Care Profile" will be used to evaluate the behavior change, motivation, and confidence levels of the participants in hypertension self-care related to lifestyle changes, and drug compliance. The hypertension self-care profile has three sub-dimensions: "Behavior", "Motivation" and "Self-efficacy". Each of the three sub-dimensions is scored separately, resulting in scores ranging from 20 to 80. Increased scores from the scale represent better self-care for a patient with hypertension.
Measured: 6th month
Change from Baseline Compliance Level for Hypertension Treatment at 6 months
"Hill-Bone Compliance to High Blood Pressure Therapy Scale" will be used to evaluate the compliance level of the participants to hypertension treatment. A minimum score of 0 and a maximum score of 42 can be obtained from the scale, and a score of 0 indicates perfect compliance with treatment. A high total score on the scale indicates a decrease in compliance with treatment.
Measured: 6th month
Change from Baseline Physical Activity Level at 6 months
"Physical Activity Questionnaire for Primary Care" will be used to evaluate the physical activity levels of the participants. The scale is applied to individuals between the ages of 16-74 and gives results at four levels: active, moderately active, less active and inactive.
Measured: 6th month
Change from Baseline Life Quality at 6 months
"SF-12 Quality of Life Scale" will be used to evaluate the quality of life of the participants. Both the physical component summary score and the mental component summary score range from 0-to 100. A higher score is indicative of better health.
Measured: 6th month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2022
- Study start1 Aug 2022
- Primary completion31 Oct 2022
- Study completion31 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eskisehir Osmangazi University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Pınar Duru, Eskisehir Osmangazi University
- Investigators
- Pınar Duru, PhD, Principal investigator, Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05390931
- Sponsor's protocol ID
- FirdesKomaç
- Status last verified
- Sep 2023
- First submitted
- 19 May 2022
- Last updated
- 7 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Motivational Interviews on Cardiovascular Disease Risks and Healthy Lifestyle Behavior Changes in Essential Hypertension Patients: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05390931
- Acronym / sponsor ID
- FirdesKomaç
- Conditions
- Essential Hypertension, Motivational Interview, Cardiovascular Disease Risk, Healthy Lifestyle Behavior
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Eskisehir Osmangazi UniversityUniversity, hospital or other
- Study start
- 1 Aug 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Mar 2023 (actual)
- First posted
- 25 May 2022 (actual)
- 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 primary aim of this study is to determine the effects of education and motivational interviews structured according to the health belief model on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis. The secondary aim of the study is to determine the effects of the variables that mediate the probability of performing primary prevention measures according to the health belief model of patients with a diagnosis of essential hypertension. The study was planned in a single-center, single-blind, one-to-one, parallel-group, randomized controlled trial design with a 6-month follow-up period. The research will be carried out at Işıklar Family Health Center located in Eskişehir city center in Turkey. The study population of this research consists of 659 patients with a diagnosis of essential hypertension, aged between 30-59 years, registered in Işıklar Family Health Center. The number of samples required for the study was determined by the power analysis made in the GPower 3.1 package program. Assuming that there may be losses during the follow-up and considering the possibility of nonparametric testing, a total of 80 individuals, 40 in each group, with an increase of 20%, will form the research group. The research data collection process will be carried out in 4 stages. First of all, the data required to query the inclusion criteria and exclusion criteria for participant admission to the study will be evaluated using the "Data form for participant admission". For the other stages of the research data collection process; "Pre-test (Beginning at 0 months)", "Intermediate follow-up test (Follow-up at 3 months)" and "Posttest (6 months)" will be administered to the participants in the study and control groups by the researcher. In this study, "Cardiovascular Disease Risk Awareness Assessment Scale", "Cardiovascular Diseases Risk Factors Knowledge Level", "Framingham Cardiovascular Risk Score", "Healthy Lifestyle Behaviors Scale-II", "Hypertension Self-Care Profile", "Hill- Bone Hypertension Treatment Adherence Scale", "Physical Activity Questionnaire for Primary Care" and "SF-12 Quality of Life Scale" will be used as data collection tools. In addition to their routine care, the control group will be given a health education structured according to the health belief model and a training booklet on healthy lifestyle behavior changes at the end of the training.
Detailed description
Hypertension plays an important role in the early death of 1 in 4 men and 1 in 5 women (more than one billion people) diagnosed with hypertension worldwide. Hypertension, the prevalence which can vary from country to country, is around 30-45% of the general population, and this rate is observed to increase with age, which will continue to be an important public health problem today and in the future. Worldwide, only one out of every 5 adults (about 21%) has hypertension under control. It is seen that the risk of cardiovascular morbidity and mortality is higher in patients whose blood pressure cannot be controlled. It is important to control hypertension in order to prevent cardiovascular diseases (CVD), also patients should comply with their treatment and health recommendations.
Motivational interviewing is a client-centered communication technique that reveals the behavior change and desire for change by helping the person to understand the problem or problems arising from himself, to discover the problem, to discover and solve the ambivalence.In this study, it is thought that motivational interviews structured according to the health belief model can be effective on cardiovascular disease risks and healthy lifestyle behavior changes in patients with an essential hypertension diagnosis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | Experimental | Behavioral: 6-session motivational interviews, Other: Health education structured according to the health belief model, Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes, Other: 6 month follow-upStudy group intervention consists of 6-session motivational interviews (6 times in total, once every month), a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and 6-month follow-up. |
| Control group | Other | Other: Health education structured according to the health belief model, Other: Training booklet prepared by the researchers on healthy lifestyle behavior changes, Other: 6 month follow-upControl group intervention consists of a health education structured according to the health belief model, a training booklet on healthy lifestyle behavior changes at the end of the training, and a 6-month follow-up. |
Who may qualify
- Ages
- 30 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Volunteer to participate in the research
- Those who are registered with any of the family physicians in the Family Health Center where the research will be conducted.
- Being in the age range of 30-59
- Having a physician-diagnosed essential hypertension
- Having estimated 10-year CHD risk ≥ 10% based on the Framingham risk score
Key exclusion criteria (6 listed)
- Having a disease like coronary artery disease, heart failure, angina, myocardial infarction, cerebrovascular diseases, cancer, or kidney failure.
- Having a pacemaker
- Having a disease like chronic obstructive pulmonary disease, neurological disorder, or psychosis and schizophrenia with severe mental illness
- Has a learning disability or communication disability
- Being pregnant
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 |
|---|---|---|
| 6-session motivational interviewsA total of 6 motivational interviews will be held once a month. Motivational interviews will be conducted individually. | Behavioural | Study group |
| Health education structured according to the health belief modelAfter the participants enrolled in the study, the patients in the study group will be given a health education structured according to the health belief model at the first interview. | Other | Control group, Study group |
| Training booklet prepared by the researchers on healthy lifestyle behavior changesAfter the participants enrolled in the study and take health education, a training booklet prepared by the researchers on healthy lifestyle behavior changes will be given to the participants. | Other | Control group, Study group |
| 6 month follow-upFollow-ups will be made 3 times in total, on the basis of pre-test, intermediate follow-up test (3 months), and post-test (6 months). | Other | Control group, Study group |
Primary outcome
Change from Baseline Systolic and Diastolic Blood Pressure at 3 months
Time frame: 3rd month
Systolic and diastolic blood pressure
Change from Baseline Systolic and Diastolic Blood Pressure at 6 months
Time frame: 6th month
Systolic and diastolic blood pressure
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 3 months
Time frame: 3rd month
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
Change from Baseline 10-year and 30-year Framingham Cardiovascular Risk Score at 6 months
Time frame: 6th month
The risk of developing cardiovascular disease in both the next 10 and 30 years will be calculated using the "Framingham cardiovascular risk score". According to the Framingham cardiovascular risk score, individuals with an estimated 10-year cardiovascular heart disease risk of <10% are considered low-risk, those between 10% and 20% are considered intermediate-risk, and individuals ≥20% are considered high-risk. The 30-year risk score estimates the 'overall' CVD risk with scores ranging from 0% to 100%. Persons with a 30-year risk score of < 12% are defined as low risk, between 12% and 40% as intermediate risk, and ≥ 40% as high risk.
Change from Baseline Healthy Lifestyle Behaviors at 6 months
Time frame: 6th month
"Healthy Lifestyle Behaviors Scale II" will be used to determine the healthy lifestyle behavior changes of the participants. A minimum of 52 and a maximum of 208 points can be obtained from the scale. Increasing scores from the scale indicate that individuals develop positive healthy lifestyle behaviors.
8 secondary outcomes
Change from Baseline Cardiovascular Disease Risk Awareness Level at 3 months
Time frame: 3rd month
Change from Baseline Cardiovascular Disease Risk Awareness Level at 6 months
Time frame: 6th month
Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 3 months
Time frame: 3rd month
Change from Baseline Cardiovascular Diseases Risk Factors Knowledge Level at 6 months
Time frame: 6th month
Change from Baseline Motivation Level, Behavior Level and Self-efficacy Level in Hypertension Self-care at 6 months
Time frame: 6th month
Change from Baseline Compliance Level for Hypertension Treatment at 6 months
Time frame: 6th month
Change from Baseline Physical Activity Level at 6 months
Time frame: 6th month
Change from Baseline Life Quality at 6 months
Time frame: 6th month
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 7 Sep 2023.
- Individual participant dataSharing planned: No
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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.
Pınar Duru, PhD principal investigator
Department of Public Health Nursing, Eskisehir Osmangazi University, Turkey
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6-session motivational interviews, Health education structured according to the health belief model and Training booklet prepared by the researchers on healthy lifestyle behavior changes in people with Essential Hypertension and Motivational Interview, run by Eskisehir Osmangazi University at 1 site in Turkey (Türkiye).
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 6 inclusion and 6 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 7 Sep 2023. 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 Turkey (Türkiye). 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 from Baseline Systolic and Diastolic Blood Pressure at 3 months (time frame: 3rd month). The study lists 5 primary outcomes in all. 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 7 Sep 2023.