Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 140
- Primary Endpoint
- Chinese version of Hypertension Self-care Profile
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 16 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Exclusion Criteria
- Not provided
Arms & Interventions
Experimental : intervention group
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.
Intervention: Health education tools combined with health literacy intervention (Behavioral)
No intervention:The control group
No intervention except conventional care were performed for the control group
Outcomes
Primary Outcomes
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
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.
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
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
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
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
Secondary Outcomes
- 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)
Investigators
ZHANG Qing-hua
Associate Professor, Ph.D
Huzhou Normal University