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Health Education for Diabetes Mellitus (hefdm)

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ClinicalTrials.gov Identifier: NCT03951168
Recruitment Status : Recruiting
First Posted : May 15, 2019
Last Update Posted : May 15, 2019
Sponsor:
Information provided by (Responsible Party):
First Affiliated Hospital Xi'an Jiaotong University

Brief Summary:
Through the construction and study of standardized diabetic health education management model. Routine diabetes health education management model was used in control group and standardized diabetes mellitus health education management model was used in intervention group. The changes of diabetic knowledge, self-management ability, quality of life,patient empowerment, HbA1c, and other metabolic indexes were observed.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus Behavioral: Routine Management Behavioral: Standardized Management Not Applicable

Detailed Description:

The aim was to develop a standardized patient education model reflecting the core educational elements recommended by Chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in China tier 3 hospital setting.

Management mode of standardized diabetes mellitus health education in intervention group.The control group carries on the routine diabetes mellitus health education management. In intervention group , All participants received Management mode of standardized diabetes mellitus health education.The standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. After discharge, patients were followed through the phone call at 2and 4 weeks. Follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. The education nurse gave recommendations according to patent's problem during the follow-up. Full-time education nurses carry on education according to diabetes mellitus health education path table. In routine, After hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. The health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. The patients were followed up by telephone 2 weeks after discharge.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Health Services Research
Official Title: Study on Standardized Management Model of Health Education for Diabetes Mellitus
Actual Study Start Date : November 1, 2018
Estimated Primary Completion Date : June 30, 2019
Estimated Study Completion Date : June 30, 2019

Arm Intervention/treatment
Routine Management
The patients were divided into routine diabetic health education management model group. Patients who meet the criteria for admission and discharge.
Behavioral: Routine Management
Routine Management Model of Health Education for diabetes Patient will receive the Routine Management Model of Health Education for Diabetes. After the patient was admitted to hospital, the responsible nurse carried on the diabetes health education for the patient. There are no regulations on the path and time of education. Interspersed with diabetes health education at work. Follow up 2 weeks with phone call after discharge. This is the current clinical model in hospital.

Experimental: Standardized Management
The patients were divided into standardized diabetes health education management model group. Patients who meet the criteria for admission and discharge.
Behavioral: Standardized Management
Standardized Management Model of Health Education for Diabetes The patients were educated by full-time diabetic education nurses according to diabetes education path. Including diabetes diet, exercise, drugs, hypoglycemia, diabetic foot, and so on. Telephone follow-up was performed at 2 weeks and 4 weeks after discharge and 12 and 24 weeks follow-up in diabetes education clinic. Develop telephone follow-up standardized content and implement telephone follow-up according to standardized content.Full-time education nurses carry on education according to diabetes mellitus health education path table.




Primary Outcome Measures :
  1. Diabetes knowledge questionnaire ( DKQ) [ Time Frame: after 6 months ]

    The DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy, clarity and content equivalence by conducting forward and back translations to verify translation equivalence.

    DKQ was translated from English into Chinese by a native bilingual translation specialist and then back translated by a different native bilingual speaker and checked for accuracy,clarity and content equivalence by conducting forward and back translations to verify translation equivalence.


  2. Summary of Diabetes Self-Care Activities-6 (SDSCA-6) [ Time Frame: after 6 months ]
    Evaluation the patient self management skill

  3. Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF) [ Time Frame: after 6 months ]
    Evaluation the patient empowerment

  4. Diabetes Specific Quality of Life [ Time Frame: after 6 months ]
    Evaluation the patient quality of life


Secondary Outcome Measures :
  1. HbA1c [ Time Frame: after 6 months ]
    the patient'S blood glucose level

  2. Fasting glucose [ Time Frame: after 6 months ]
    the patient'S blood glucose level

  3. 2h postprandial glucose [ Time Frame: after 6 months ]
    the patient'S blood glucose level

  4. blood pressure [ Time Frame: after 6 months ]
    the patient 'S blood pressure

  5. Total Cholesterol [ Time Frame: after 6 months ]
    the patient'S Total Cholesterol

  6. LDL-C [ Time Frame: after 6 months ]
    he patient'S LDL-C

  7. HDL-C [ Time Frame: after 6 months ]
    he patient'S HDL-C



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients with World Health Organization(WHO) diagnosis (1999);
  • HbA1c ≥ 7.5%;
  • history of diabetes < 2 years;
  • age from 18 to 70 years;
  • having the ability of autonomous behavior, informed consent and voluntary participation in the study.

Exclusion Criteria:

  • type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes;
  • severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc.
  • is participating in other researchers.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03951168


Contacts
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Contact: Meng Li 13720511988 limeng2000@126.com

Locations
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China, Shaanxi
First affiliated Hospital of Xi'an Jiaotong University Recruiting
Xi'an, Shaanxi, China, 710061
Contact: Meng Li    13720511988    limeng2000@126.com   
Sponsors and Collaborators
First Affiliated Hospital Xi'an Jiaotong University
Investigators
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Study Chair: Meng Li First Affiliated Hospital of Xi'an JiaoTong Univerisity

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Responsible Party: First Affiliated Hospital Xi'an Jiaotong University
ClinicalTrials.gov Identifier: NCT03951168     History of Changes
Other Study ID Numbers: 2018KRM115
First Posted: May 15, 2019    Key Record Dates
Last Update Posted: May 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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

Keywords provided by First Affiliated Hospital Xi'an Jiaotong University:
Diabetes Mellitus
Health education for diabetes

Additional relevant MeSH terms:
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Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases