Clinical trial NCT04327102: Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy
Official title: Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Health Literacy
Hypertension
Keywords: health literacy
hypertension
Lead sponsor: Huzhou Normal University
Sponsor class: OTHER
First posted: 2020-03-30
Enrollment: 140
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Eligibility criteria: 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.

Primary outcomes:
measure: High Blood Pressure-Health Literacy Scale into Chinese
timeFrame: 12 months
measure: Systolic and diastolic blood pressure in hypertension
timeFrame: 12 months
measure: Body Mass Index ，BMI
timeFrame: 12 months
measure: Waist Circumference，WC
timeFrame: 12 months
measure: Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores
timeFrame: 12 months
measure: Chinese version of Hypertension Self-care Profile
timeFrame: 12 months
Secondary outcomes:
measure: Fasting Glucose, Glu
timeFrame: 12months
measure: Low Density Lipoprotein, LDL
timeFrame: 12 months
measure: The self rated health status of the patients
timeFrame: 12 months
measure: Total Cholesterol, TC
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
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