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

NCT04327102 | Unknown

• 1 other identifier: HuzhouNormalU
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Health Literacy; Hypertension

Keywords

health literacy; hypertension

Outcome Measures

Primary Outcomes (6)

• 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

• Systolic and diastolic blood pressure in hypertension

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

  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

  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

  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

  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

  12 months

Secondary Outcomes (4)

• Fasting Glucose, Glu

  12months

• Low Density Lipoprotein, LDL

  12 months

• The self rated health status of the patients

  12 months

• Total Cholesterol, TC

  12 months

Study Arms (2)

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.

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

Interventions

Health education tools combined with health literacy intervention BEHAVIORAL

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.

Experimental : intervention group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

Sponsors & Collaborators

• Huzhou Normal University: lead

Related Publications (12)

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• Gan 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.

  PMID: 35505379 DERIVED

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Central Study Contacts

Qing-hua ZHANG

CONTACT

18906822965; 02598@zjhu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Ph.D

Study Record Dates

• First Submitted: February 29, 2020
• First Posted: March 30, 2020
• Study Start: May 1, 2020
• Primary Completion: May 1, 2021
• Study Completion: August 1, 2021
• Last Updated: March 30, 2020

Record last verified: 2020-03