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

Primary Purpose

Health Literacy, Hypertension

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Health education tools combined with health literacy intervention
Sponsored by
Huzhou Normal University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Health Literacy focused on measuring health literacy, hypertension

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Experimental : intervention group

    No intervention:The control group

    Arm Description

    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.

    No intervention except conventional care were performed for the control group

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Fasting Glucose, Glu
    Comparison of changes in indicators before and after intervention
    Low Density Lipoprotein, LDL
    Comparison of changes in indicators before and after intervention
    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
    Total Cholesterol, TC
    Comparison of changes in indicators before and after intervention

    Full Information

    First Posted
    February 29, 2020
    Last Updated
    March 27, 2020
    Sponsor
    Huzhou Normal University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04327102
    Brief Title
    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

    2. Study Status

    Record Verification Date
    March 2020
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 1, 2020 (Anticipated)
    Primary Completion Date
    May 1, 2021 (Anticipated)
    Study Completion Date
    August 1, 2021 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Huzhou Normal University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Health Literacy, Hypertension
    Keywords
    health literacy, hypertension

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    140 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Experimental : intervention group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    No intervention:The control group
    Arm Type
    No Intervention
    Arm Description
    No intervention except conventional care were performed for the control group
    Intervention Type
    Behavioral
    Intervention Name(s)
    Health education tools combined with health literacy intervention
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    High Blood Pressure-Health Literacy Scale into Chinese
    Description
    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.
    Time Frame
    12 months
    Title
    Systolic and diastolic blood pressure in hypertension
    Description
    The decrease of systolic and diastolic blood pressure in hypertension patients after health literacy intervention
    Time Frame
    12 months
    Title
    Body Mass Index ,BMI
    Description
    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
    Time Frame
    12 months
    Title
    Waist Circumference,WC
    Description
    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
    Time Frame
    12 months
    Title
    Quality of Life Instruments for Chronic Diseases - Hypertension V2.0: scale scores
    Description
    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
    Time Frame
    12 months
    Title
    Chinese version of Hypertension Self-care Profile
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Fasting Glucose, Glu
    Description
    Comparison of changes in indicators before and after intervention
    Time Frame
    12months
    Title
    Low Density Lipoprotein, LDL
    Description
    Comparison of changes in indicators before and after intervention
    Time Frame
    12 months
    Title
    The self rated health status of the patients
    Description
    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
    Time Frame
    12 months
    Title
    Total Cholesterol, TC
    Description
    Comparison of changes in indicators before and after intervention
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Qing-hua ZHANG
    Phone
    18906822965
    Email
    02598@zjhu.cn

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
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    Health Management Model Construction and Effect Evaluation of Hypertension Patients Based on Disease-related Health Literacy

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