Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy

Hypertension Clinical Trial

Official title:

Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04327102
• Other study ID #: HuzhouNormalU
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 1, 2020
• Est. completion date: August 1, 2021

Study information

• Verified date: March 2020
• Source: Huzhou Normal University
• Contact: Qing-hua ZHANG
• Phone: 18906822965
• Email: 02598[@]zjhu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 140
• Est. completion date: August 1, 2021
• Est. primary completion date: May 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

Inclusion Criteria:

• 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.

Inclusion Criteria:

• All kinds of secondary hypertension patients;

• 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.

Related Conditions & MeSH terms

• Health Literacy
• Hypertension

Intervention

Behavioral:
• Health education tools combined with health literacy intervention
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Huzhou Normal University

References & Publications (11)

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Institute 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. — View Citation

McNaughton 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. — View Citation

Morrow 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. — View Citation

Pandit 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. Epu — View Citation

Pleasant 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. — View Citation

Shibuya 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.0b013e32834a — View Citation

Sperber 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/h — View Citation

Wang 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 — View Citation

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months
Primary	Systolic and diastolic blood pressure in hypertension	The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention	12 months
Primary	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	12 months
Primary	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	12 months
Primary	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	12 months
Primary	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	12 months
Secondary	Fasting Glucose, Glu	Comparison of changes in indicators before and after intervention	12months
Secondary	Low Density Lipoprotein, LDL	Comparison of changes in indicators before and after intervention	12 months
Secondary	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	12 months
Secondary	Total Cholesterol, TC	Comparison of changes in indicators before and after intervention	12 months