Health Education for Diabetes Mellitus

NCT03951168 | Completed

• 1 other identifier: 2018KRM115
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Diabetes Mellitus; Health education for diabetes

Outcome Measures

Primary Outcomes (4)

• 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

• Summary of Diabetes Self-Care Activities-6 (SDSCA-6)

  Evaluation the patient self management skill

  after 6 months

• Diabetes empowerment Scale-Diabetes Attitudes Wishes & Needs Short Form (DES-DSF)

  Evaluation the patient empowerment

  after 6 months

• Diabetes Specific Quality of Life

  Evaluation the patient quality of life

  after 6 months

Secondary Outcomes (7)

• HbA1c

  after 6 months

• Fasting glucose

  after 6 months

• 2h postprandial glucose

  after 6 months

• blood pressure

  after 6 months

• Total Cholesterol

  after 6 months

Study Arms (2)

Routine Management

OTHER

The patients were divided into routine diabetic health education management model group. Patients who meet the criteria for admission and discharge.

Behavioral: Routine Management

Standardized Management

EXPERIMENTAL

The patients were divided into standardized diabetes health education management model group. Patients who meet the criteria for admission and discharge.

Behavioral: Standardized Management

Interventions

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.

Routine Management

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.

Standardized Management

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• First Affiliated Hospital Xi'an Jiaotong University: lead

Study Sites (1)

First affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710061, China

Location

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Meng Li

  First Affiliated Hospital of Xi'an JiaoTong Univerisity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2019
• First Posted: May 15, 2019
• Study Start: July 1, 2019
• Primary Completion: June 30, 2020
• Study Completion: June 30, 2020
• Last Updated: November 18, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)