Health Education for Diabetes Mellitus

Diabetes Mellitus Clinical Trial

— hefdm  

Official title:

Study on Standardized Management Model of Health Education for Diabetes Mellitus

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03951168
• Other study ID #: 2018KRM115
• Status: Completed
• Phase: N/A
• Start date: July 1, 2019
• Est. completion date: June 30, 2020

Study information

• Verified date: November 2020
• Source: First Affiliated Hospital Xi'an Jiaotong University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 206
• Est. completion date: June 30, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
China	First affiliated Hospital of Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital Xi'an Jiaotong University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diabetes knowledge questionnaire ( DKQ)	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.	after 6 months
Primary	Summary of Diabetes Self-Care Activities-6 (SDSCA-6)	Evaluation the patient self management skill	after 6 months
Primary	Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)	Evaluation the patient empowerment	after 6 months
Primary	Diabetes Specific Quality of Life	Evaluation the patient quality of life	after 6 months
Secondary	HbA1c	the patient'S blood glucose level	after 6 months
Secondary	Fasting glucose	the patient'S blood glucose level	after 6 months
Secondary	2h postprandial glucose	the patient'S blood glucose level	after 6 months
Secondary	blood pressure	the patient 'S blood pressure	after 6 months
Secondary	Total Cholesterol	the patient'S Total Cholesterol	after 6 months
Secondary	LDL-C	he patient'S LDL-C	after 6 months
Secondary	HDL-C	he patient'S HDL-C	after 6 months