Health Education for Diabetes Mellitus

Not Applicable

Completed

• Conditions: Diabetes Mellitus
• Interventions: Behavioral: Routine Management; Behavioral: Standardized Management

• Registration Number: NCT03951168
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2019-05-04
• Study First Submitted QC: 2019-05-13
• Study First Posted: 2019-05-15
• Study Start: 2019-07-01
• Primary Completion: 2020-06-30
• Study Completion: 2020-06-30
• Status Verified: 2020-11
• Last Update Submitted: 2020-11-17
• Last Update Posted: 2020-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 206

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Routine Management	Routine Management	The patients were divided into routine diabetic health education management model group. Patients who meet the criteria for admission and discharge.
Standardized Management	Standardized Management	The patients were divided into standardized diabetes health education management model group. Patients who meet the criteria for admission and discharge.

Primary Outcome Measures

Name	Time	Method
Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)	after 6 months	Evaluation the patient empowerment
Diabetes knowledge questionnaire ( DKQ)	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.
Summary of Diabetes Self-Care Activities-6 (SDSCA-6)	after 6 months	Evaluation the patient self management skill
Diabetes Specific Quality of Life	after 6 months	Evaluation the patient quality of life

Secondary Outcome Measures

Name	Time	Method
Fasting glucose	after 6 months	the patient'S blood glucose level
Total Cholesterol	after 6 months	the patient'S Total Cholesterol
HbA1c	after 6 months	the patient'S blood glucose level
HDL-C	after 6 months	he patient'S HDL-C
2h postprandial glucose	after 6 months	the patient'S blood glucose level
blood pressure	after 6 months	the patient 'S blood pressure
LDL-C	after 6 months	he patient'S LDL-C

Trial Locations

Locations (1)

First affiliated Hospital of Xi'an Jiaotong University; 🇨🇳 Xi'an, Shaanxi, China