Health LiteracyNCT04327102
Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy
A study testing Health education tools combined with health literacy intervention in people with Health Literacy and Hypertension, run by Huzhou Normal University.
Trial summary
Huzhou City, Zhejiang Province was chosen as the research site, and a general hospital was randomly selected. The "Chinese version of hypertension health literacy scale" of the tutor of this research group was used to evaluate the health literacy level of inpatients with hypertension in the Department of Cardiology… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Health Literacy, Hypertension
- What is being tested?
- Health education tools combined with health literacy intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2020to 1 Aug 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 16 years old and has lived in Huzhou for nearly half a year;
- The Chinese version of the hypertension health literacy scale was used to evaluate the health literacy of those with a total score of less than 32 + the critical group;
- In line with the diagnostic criteria for essential hypertension set out in China's hypertension prevention and control guidelines in 2018, systolic blood pressure ≥ 140mmHg, and / or diastolic blood pressure ≥ 90mmHg;
- In the last half year, the living condition is stable, and there is no major stress event (such as the death of relatives, etc.);
- Volunteer to participate in the study, and sign the informed consent of research willingness.
- All kinds of secondary hypertension patients;
Show all 10Show fewer
- Major stress events occurred during the study period;
- Have serious mental disorder or serious cognitive function defect;
- Patients with severe acute and chronic physical diseases；
- Cardiovascular risk factors: low risk or high risk.
Who cannot join
None listed.
Trial locations and contacts
No sites are listed yet.
About this study
Huzhou City, Zhejiang Province was chosen as the research site, and a general hospital was randomly selected. The "Chinese version of hypertension health literacy scale" of the tutor of this research group was used to evaluate the health literacy level of inpatients with hypertension in the Department of Cardiology, and the patients with critical and lack of health literacy were selected as the research objects. In the control group, routine health management was carried out. On the basis of the control group, the intervention group used health education tools combined with health literacy intervention to implement interactive health management for 12 months. The results of the intervention measures were compared to evaluate the effects of the intervention measures on improving the health literacy level, Hypertension Self-care ability, quality of life and reducing systolic and diastolic blood pressure, body mass index, waist circumference, physiological and biochemical indicators of the patients, so as to provide theoretical basis and practical reference for the further development of prevention and treatment strategies of hypertension patients.
Read the detailed description
First, the Chinese version of hypertension health literacy scale was used to evaluate the health literacy of inpatients in a hospital, and then the critical and lack of health literacy patients were selected as the research objects.
Then, taking a place in Huzhou City of Zhejiang Province as the research site, a general hospital was randomly selected. According to the ratio of male to female = 1:1, the hypertension patients who meet the inclusion criteria were screened until the intervention group and the control group reached the required sample size. Patients were randomly assigned to the intervention group and the control group.
After the patients signed the informed consent, the patients were intervened. Finally, data collection and statistical processing are carried out
- Conditions
- Health Literacy, Hypertension
- Being tested
- Health education tools combined with health literacy intervention
- Keywords
- health literacy, hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health education tools combined with health literacy interventionBehavioural
On the basis of the control group, the intervention measures to improve the health literacy of patients were implemented and self-made health education tools were used. During hospitalization, health knowledge lectures shall be organized for patients. Before the activity, the theme of the activity shall be clarified. Each participant shall be organized by the educator to sit on the tool chart in a U-shape. According to the theme of the tool map, patients interact with educators. And learn the knowledge content related to hypertension health literacy. Before the end of the activity, the educator will review all the contents discussed in the activity quickly, answer the questions in the activity, and help the participants to sort out and consolidate the knowledge acquired in the education. Follow up intervention for patients after leave hospital.
| Study group | Role | What they receive |
|---|---|---|
| Experimental : intervention group | Experimental | Combination of health education tools and health literacy intervention: on the basis of the control group, the hypertension health education tools are used as the education media to encourage patients to find out the elements of the tool chart, use the picture content to guide the topic development, encourage patients to discuss with each other, realize heuristic questions, rather than a single indoctrination, so as to deepen the understanding and memory of patients. At the end of the course, patients are encouraged to set short-term goals to encourage behaviors that continue to achieve larger goals. At the same time, health literacy lectures were organized during the hospitalization. Health literacy lecture is mainly to learn the information that hypertension needs to pay attention to in order to improve the health literacy of hypertension patients and other indicators. Receives: Behavioral: Health education tools combined with health literacy intervention |
| No intervention:The control group | No intervention | No intervention except conventional care were performed for the control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
High Blood Pressure-Health Literacy Scale into Chinese
The scale consists of 15 items and 5 dimensions, with a total score of 0-60. One score will be given if one question is answered correctly. The higher the score is, the higher the HL level is. According to the TOFHLA classification standard, HL level is divided into three levels. If the score is less than 32, the HL level is deficient; if the score is 32-40, the HL level is critical; if the score is more than 40, the HL level is sufficient. The score of the scale before and after the intervention was compared.
Measured: 12 months
Systolic and diastolic blood pressure in hypertension
The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention
Measured: 12 months
Body Mass Index ，BMI
According to 2008 WHO guidelines, BMI < 25 kg / m2 is normal weight or low weight, 30 kg / m2 > BMI ≥ 25 kg / m2 is overweight, BMI ≥ 30 kg / m2 is obesity. To evaluate the changes of BMI of patients before and after intervention
Measured: 12 months
Waist Circumference，WC
WC ≥ 102CM in male and 88cm in female were abdominal obesity, 94cm ≤ male WC < 102CM, 80cm ≤ female WC < 88cm are abdominal overweight, WC < 94cm in male and 80cm in female is normal.To evaluate the changes of WC of patients before and after intervention
Measured: 12 months
Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores
The scale consists of 41 items and uses the five point equidistant scoring method. The scores are 1, 2, 3, 4 and 5 in turn. The total score of the scale is between 41 and 205. The higher the score, the better the quality of life.Compare the changes of the scale scores before and after the intervention
Measured: 12 months
Chinese version of Hypertension Self-care Profile
There are 60 items in the scale. Each item in the scale is 1-4 points, and the total score of the scale is 60-240 points. The higher the score, the better the self-care ability. Compare the changes of patients' scale scores before and after intervention
Measured: 12 months
Secondary outcomes (4)
Fasting Glucose, Glu
Comparison of changes in indicators before and after intervention
Measured: 12months
Low Density Lipoprotein, LDL
Comparison of changes in indicators before and after intervention
Measured: 12 months
The self rated health status of the patients
Draw a scale with a minimum of 0 and a maximum of 100. 0 represents the worst health condition in the patient's mind, and 100 represents the best health condition in the patient's mind.
Please mark the health status of the participants on the scale to help them reflect the health status
Measured: 12 months
Total Cholesterol, TC
Comparison of changes in indicators before and after intervention
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2020
- Study start1 May 2020 (estimated)
- Primary completion1 May 2021 (estimated)
- Study completion1 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Health LiteracyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huzhou Normal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, ZHANG Qing-hua, Huzhou Normal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04327102
- Sponsor's protocol ID
- HuzhouNormalU
- Status last verified
- Mar 2020
- First submitted
- 29 Feb 2020
- Last updated
- 30 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Funnell MM, Anderson RM, Arnold MS, Barr PA, Donnelly M, Johnson PD, Taylor-Moon D, White NH. Empowerment: an idea whose time has come in diabetes education. Diabetes Educ. 1991 Jan-Feb;17(1):37-41. doi: 10.1177/014572179101700108.
PubMed 1986902Wang J, Zhang L, Wang F, Liu L, Wang H; China National Survey of Chronic Kidney Disease Working Group. Prevalence, awareness, treatment, and control of hypertension in China: results from a national survey. Am J Hypertens. 2014 Nov;27(11):1355-61. doi: 10.1093/ajh/hpu053. Epub 2014 Apr 3.
PubMed 24698853Danaei G, Finucane MM, Lin JK, Singh GM, Paciorek CJ, Cowan MJ, Farzadfar F, Stevens GA, Lim SS, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Pressure). National, regional, and global trends in systolic blood pressure since 1980: systematic analysis of health examination surveys and epidemiological studies with 786 country-years and 5.4 million participants. Lancet. 2011 Feb 12;377(9765):568-77. doi: 10.1016/S0140-6736(10)62036-3. Epub 2011 Feb 3.
PubMed 21295844Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
PubMed 25009856Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22.
PubMed 23525779McNaughton CD, Jacobson TA, Kripalani S. Low literacy is associated with uncontrolled blood pressure in primary care patients with hypertension and heart disease. Patient Educ Couns. 2014 Aug;96(2):165-70. doi: 10.1016/j.pec.2014.05.007. Epub 2014 May 14.
PubMed 24882088Pandit AU, Tang JW, Bailey SC, Davis TC, Bocchini MV, Persell SD, Federman AD, Wolf MS. Education, literacy, and health: Mediating effects on hypertension knowledge and control. Patient Educ Couns. 2009 Jun;75(3):381-5. doi: 10.1016/j.pec.2009.04.006. Epub 2009 May 12.
PubMed 19442477Morrow D, Clark D, Tu W, Wu J, Weiner M, Steinley D, Murray MD. Correlates of health literacy in patients with chronic heart failure. Gerontologist. 2006 Oct;46(5):669-76. doi: 10.1093/geront/46.5.669.
PubMed 17050758Shibuya A, Inoue R, Ohkubo T, Takeda Y, Teshima T, Imai Y, Kondo Y. The relation between health literacy, hypertension knowledge, and blood pressure among middle-aged Japanese adults. Blood Press Monit. 2011 Oct;16(5):224-30. doi: 10.1097/MBP.0b013e32834af7ba.
PubMed 21857504Pleasant A. Advancing health literacy measurement: a pathway to better health and health system performance. J Health Commun. 2014 Dec;19(12):1481-96. doi: 10.1080/10810730.2014.954083.
PubMed 25491583Chinenye S, Young EE. Diabetes conversation map in Nigeria: A new socioeducational tool in diabetes care. Indian J Endocrinol Metab. 2013 Nov;17(6):1009-11. doi: 10.4103/2230-8210.122613.
PubMed 24381876Gan W, Zhang Q, Yang D, Yin J, Wang Y, Song L, Chen T, Qi H. A behavior change wheel-based interactive pictorial health education program for hypertensive patients with low blood pressure health literacy: study protocol for a randomized controlled trial. Trials. 2022 May 3;23(1):369. doi: 10.1186/s13063-022-06300-1.
PubMed 35505379
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy
- ClinicalTrials.gov ID
- NCT04327102
- Acronym / sponsor ID
- HuzhouNormalU
- Conditions
- Health Literacy, Hypertension
- Keywords
- health literacy, hypertension
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Huzhou Normal UniversityUniversity, hospital or other
- Study start
- 1 May 2020 (estimated)
- Primary completion
- 1 May 2021 (estimated)
- Study completion
- 1 Aug 2021 (estimated)
- First posted
- 30 Mar 2020 (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.
Huzhou City, Zhejiang Province was chosen as the research site, and a general hospital was randomly selected. The "Chinese version of hypertension health literacy scale" of the tutor of this research group was used to evaluate the health literacy level of inpatients with hypertension in the Department of Cardiology, and the patients with critical and lack of health literacy were selected as the research objects. In the control group, routine health management was carried out. On the basis of the control group, the intervention group used health education tools combined with health literacy intervention to implement interactive health management for 12 months. The results of the intervention measures were compared to evaluate the effects of the intervention measures on improving the health literacy level, Hypertension Self-care ability, quality of life and reducing systolic and diastolic blood pressure, body mass index, waist circumference, physiological and biochemical indicators of the patients, so as to provide theoretical basis and practical reference for the further development of prevention and treatment strategies of hypertension patients.
Detailed description
First, the Chinese version of hypertension health literacy scale was used to evaluate the health literacy of inpatients in a hospital, and then the critical and lack of health literacy patients were selected as the research objects.
Then, taking a place in Huzhou City of Zhejiang Province as the research site, a general hospital was randomly selected. According to the ratio of male to female = 1:1, the hypertension patients who meet the inclusion criteria were screened until the intervention group and the control group reached the required sample size. Patients were randomly assigned to the intervention group and the control group.
After the patients signed the informed consent, the patients were intervened. Finally, data collection and statistical processing are carried out
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental : intervention group | Experimental | Behavioral: Health education tools combined with health literacy interventionCombination of health education tools and health literacy intervention: on the basis of the control group, the hypertension health education tools are used as the education media to encourage patients to find out the elements of the tool chart, use the picture content to guide the topic development, encourage patients to discuss with each other, realize heuristic questions, rather than a single indoctrination, so as to deepen the understanding and memory of patients. At the end of the course, patients are encouraged to set short-term goals to encourage behaviors that continue to achieve larger goals. At the same time, health literacy lectures were organized during the hospitalization. Health literacy lecture is mainly to learn the information that hypertension needs to pay attention to in order to improve the health literacy of hypertension patients and other indicators. |
| No intervention:The control group | No intervention | –No intervention except conventional care were performed for the control group |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 16 years old and has lived in Huzhou for nearly half a year;
- The Chinese version of the hypertension health literacy scale was used to evaluate the health literacy of those with a total score of less than 32 + the critical group;
- In line with the diagnostic criteria for essential hypertension set out in China's hypertension prevention and control guidelines in 2018, systolic blood pressure ≥ 140mmHg, and / or diastolic blood pressure ≥ 90mmHg;
- In the last half year, the living condition is stable, and there is no major stress event (such as the death of relatives, etc.);
- Volunteer to participate in the study, and sign the informed consent of research willingness.
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Health education tools combined with health literacy interventionOn the basis of the control group, the intervention measures to improve the health literacy of patients were implemented and self-made health education tools were used. During hospitalization, health knowledge lectures shall be organized for patients. Before the activity, the theme of the activity shall be clarified. Each participant shall be organized by the educator to sit on the tool chart in a U-shape. According to the theme of the tool map, patients interact with educators. And learn the knowledge content related to hypertension health literacy. Before the end of the activity, the educator will review all the contents discussed in the activity quickly, answer the questions in the activity, and help the participants to sort out and consolidate the knowledge acquired in the education. Follow up intervention for patients after leave hospital. | Behavioural | Experimental : intervention group |
Primary outcome
High Blood Pressure-Health Literacy Scale into Chinese
Time frame: 12 months
The scale consists of 15 items and 5 dimensions, with a total score of 0-60. One score will be given if one question is answered correctly. The higher the score is, the higher the HL level is. According to the TOFHLA classification standard, HL level is divided into three levels. If the score is less than 32, the HL level is deficient; if the score is 32-40, the HL level is critical; if the score is more than 40, the HL level is sufficient. The score of the scale before and after the intervention was compared.
Systolic and diastolic blood pressure in hypertension
Time frame: 12 months
The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention
Body Mass Index ，BMI
Time frame: 12 months
According to 2008 WHO guidelines, BMI < 25 kg / m2 is normal weight or low weight, 30 kg / m2 > BMI ≥ 25 kg / m2 is overweight, BMI ≥ 30 kg / m2 is obesity. To evaluate the changes of BMI of patients before and after intervention
Waist Circumference，WC
Time frame: 12 months
WC ≥ 102CM in male and 88cm in female were abdominal obesity, 94cm ≤ male WC < 102CM, 80cm ≤ female WC < 88cm are abdominal overweight, WC < 94cm in male and 80cm in female is normal.To evaluate the changes of WC of patients before and after intervention
Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores
Time frame: 12 months
The scale consists of 41 items and uses the five point equidistant scoring method. The scores are 1, 2, 3, 4 and 5 in turn. The total score of the scale is between 41 and 205. The higher the score, the better the quality of life.Compare the changes of the scale scores before and after the intervention
Chinese version of Hypertension Self-care Profile
Time frame: 12 months
There are 60 items in the scale. Each item in the scale is 1-4 points, and the total score of the scale is 60-240 points. The higher the score, the better the self-care ability. Compare the changes of patients' scale scores before and after intervention
4 secondary outcomes
Fasting Glucose, Glu
Time frame: 12months
Low Density Lipoprotein, LDL
Time frame: 12 months
The self rated health status of the patients
Time frame: 12 months
Total Cholesterol, TC
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
- Background: PubMed 1986902Funnell MM, Anderson RM, Arnold MS, Barr PA, Donnelly M, Johnson PD, Taylor-Moon D, White NH. Empowerment: an idea whose time has come in diabetes education. Diabetes Educ. 1991 Jan-Feb;17(1):37-41. doi: 10.1177/014572179101700108.
- Results publication: PubMed 24698853Wang J, Zhang L, Wang F, Liu L, Wang H; China National Survey of Chronic Kidney Disease Working Group. Prevalence, awareness, treatment, and control of hypertension in China: results from a national survey. Am J Hypertens. 2014 Nov;27(11):1355-61. doi: 10.1093/ajh/hpu053. Epub 2014 Apr 3.
- Results publication: PubMed 21295844Danaei G, Finucane MM, Lin JK, Singh GM, Paciorek CJ, Cowan MJ, Farzadfar F, Stevens GA, Lim SS, Riley LM, Ezzati M; Global Burden of Metabolic Risk Factors of Chronic Diseases Collaborating Group (Blood Pressure). National, regional, and global trends in systolic blood pressure since 1980: systematic analysis of health examination surveys and epidemiological studies with 786 country-years and 5.4 million participants. Lancet. 2011 Feb 12;377(9765):568-77. doi: 10.1016/S0140-6736(10)62036-3. Epub 2011 Feb 3.
- Results publication: PubMed 25009856Institute of Medicine (US) Committee on Health Literacy; Nielsen-Bohlman L, Panzer AM, Kindig DA, editors. Health Literacy: A Prescription to End Confusion. Washington (DC): National Academies Press (US); 2004. Available from http://www.ncbi.nlm.nih.gov/books/NBK216032/
- Results publication: PubMed 23525779Sperber NR, Bosworth HB, Coffman CJ, Lindquist JH, Oddone EZ, Weinberger M, Allen KD. Differences in osteoarthritis self-management support intervention outcomes according to race and health literacy. Health Educ Res. 2013 Jun;28(3):502-11. doi: 10.1093/her/cyt043. Epub 2013 Mar 22.
- Results publication: PubMed 24882088McNaughton CD, Jacobson TA, Kripalani S. Low literacy is associated with uncontrolled blood pressure in primary care patients with hypertension and heart disease. Patient Educ Couns. 2014 Aug;96(2):165-70. doi: 10.1016/j.pec.2014.05.007. Epub 2014 May 14.
- Results publication: PubMed 19442477Pandit AU, Tang JW, Bailey SC, Davis TC, Bocchini MV, Persell SD, Federman AD, Wolf MS. Education, literacy, and health: Mediating effects on hypertension knowledge and control. Patient Educ Couns. 2009 Jun;75(3):381-5. doi: 10.1016/j.pec.2009.04.006. Epub 2009 May 12.
- Results publication: PubMed 17050758Morrow D, Clark D, Tu W, Wu J, Weiner M, Steinley D, Murray MD. Correlates of health literacy in patients with chronic heart failure. Gerontologist. 2006 Oct;46(5):669-76. doi: 10.1093/geront/46.5.669.
- Results publication: PubMed 21857504Shibuya A, Inoue R, Ohkubo T, Takeda Y, Teshima T, Imai Y, Kondo Y. The relation between health literacy, hypertension knowledge, and blood pressure among middle-aged Japanese adults. Blood Press Monit. 2011 Oct;16(5):224-30. doi: 10.1097/MBP.0b013e32834af7ba.
- Results publication: PubMed 25491583Pleasant A. Advancing health literacy measurement: a pathway to better health and health system performance. J Health Commun. 2014 Dec;19(12):1481-96. doi: 10.1080/10810730.2014.954083.
- Results publication: PubMed 24381876Chinenye S, Young EE. Diabetes conversation map in Nigeria: A new socioeducational tool in diabetes care. Indian J Endocrinol Metab. 2013 Nov;17(6):1009-11. doi: 10.4103/2230-8210.122613.
- Derived from this study: PubMed 35505379Gan W, Zhang Q, Yang D, Yin J, Wang Y, Song L, Chen T, Qi H. A behavior change wheel-based interactive pictorial health education program for hypertensive patients with low blood pressure health literacy: study protocol for a randomized controlled trial. Trials. 2022 May 3;23(1):369. doi: 10.1186/s13063-022-06300-1.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Health education tools combined with health literacy intervention in people with Health Literacy and Hypertension, run by Huzhou Normal University.
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 10 inclusion and 0 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 30 Mar 2020. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Qing-hua ZHANG (18906822965, 02598@zjhu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
High Blood Pressure-Health Literacy Scale into Chinese (time frame: 12 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04327102, which also lists 12 linked publications.
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 30 Mar 2020.