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临床试验/NCT04327102
NCT04327102Unknown不适用

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

Huzhou Normal University0 个研究点目标入组 140 人开始时间: 2020年5月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
发起方
入组人数
140
主要终点
Chinese version of Hypertension Self-care Profile

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
16 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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.

排除标准

  • 未提供

研究组 & 干预措施

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.

干预措施: Health education tools combined with health literacy intervention (Behavioral)

No intervention:The control group

No Intervention

No intervention except conventional care were performed for the control group

结局指标

主要结局

Chinese version of Hypertension Self-care Profile

时间窗: 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

High Blood Pressure-Health Literacy Scale into Chinese

时间窗: 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.

Body Mass Index ,BMI

时间窗: 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

Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores

时间窗: 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

Systolic and diastolic blood pressure in hypertension

时间窗: 12 months

The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention

Waist Circumference,WC

时间窗: 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

次要结局

  • Fasting Glucose, Glu(12months)
  • Low Density Lipoprotein, LDL(12 months)
  • Total Cholesterol, TC(12 months)
  • The self rated health status of the patients(12 months)

研究者

发起方
Huzhou Normal University
申办方类型
Other
责任方
Principal Investigator
主要研究者

ZHANG Qing-hua

Associate Professor, Ph.D

Huzhou Normal University

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