Clinical trial NCT03951168: Health Education for Diabetes Mellitus
Official title: Study on Standardized Management Model of Health Education for Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus
Keywords: Diabetes Mellitus
Health education for diabetes
Lead sponsor: First Affiliated Hospital Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2019-05-15
Enrollment: 206
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility 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.

Primary outcomes:
measure: Diabetes knowledge questionnaire ( DKQ)
timeFrame: after 6 months
measure: Summary of Diabetes Self-Care Activities-6 (SDSCA-6)
timeFrame: after 6 months
measure: Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)
timeFrame: after 6 months
measure: Diabetes Specific Quality of Life
timeFrame: after 6 months
Secondary outcomes:
measure: HbA1c
timeFrame: after 6 months
measure: Fasting glucose
timeFrame: after 6 months
measure: 2h postprandial glucose
timeFrame: after 6 months
measure: blood pressure
timeFrame: after 6 months
measure: Total Cholesterol
timeFrame: after 6 months
measure: LDL-C
timeFrame: after 6 months
measure: HDL-C
timeFrame: after 6 months
Other outcomes:
Locations:
city: Xi'an
country: China
facility: First affiliated Hospital of Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: First Affiliated Hospital of Xi'an JiaoTong Univerisity
name: Meng Li
role: STUDY_CHAIR
References: