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Completed

NCT Number: NCT03951168

Health Education for Diabetes Mellitus

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

First affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Routine Management

Behavioral

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.

Standardized Management

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

First Affiliated Hospital Xi'an Jiaotong University

Other

Registry information

Official study title

Study on Standardized Management Model of Health Education for Diabetes Mellitus

Acronym: hefdm

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 15, 2019
Registry last updated
Nov 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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