Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study

NCT ID: NCT06384118

Last Updated: 2024-04-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2024-01-17

Brief Summary

From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program.

Detailed Description

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on IMB theory given on top of regular diabetes health education) and a control group (regular diabetes health education), with a 4-week intervention period and a 8-week follow-up period, for a total of 12 weeks.

Conditions

Type 2 Diabetes Mellitus; Hypoglycemia; Health Education

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: DOUBLE

Study Groups

intervention group

Based on IMB Theory of Health Education A hypoglycemia coping intervention program based on IMB theory was implemented on top of the control group.

Group Type: EXPERIMENTAL

Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study

Intervention Type: BEHAVIORAL

Based on IMB health education theory Questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; hypoglycemia knowledge promotion on the second day; Peer experience sharing on the third day; access to WeChat group and knowledge pushing on the fourth day; hypoglycemia-related lectures and practical teaching on the fifth day, face-to-face teaching and development of blood glucose management plan. Hypoglycemia knowledge contest on the day before discharge; One week, two weeks and three weeks after discharge for WeChat push or phone call; WeChat push, phone call and questionnaire.

the control group

General diabetes health education Patients were provided with regular medication guidance, dietary guidance, exercise guidance and popularization of related diabetes knowledge; regular daily blood glucose testing and recording; and timely answers to patients' clinical problems and psychological support.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study

Based on IMB health education theory Questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; hypoglycemia knowledge promotion on the second day; Peer experience sharing on the third day; access to WeChat group and knowledge pushing on the fourth day; hypoglycemia-related lectures and practical teaching on the fifth day, face-to-face teaching and development of blood glucose management plan. Hypoglycemia knowledge contest on the day before discharge; One week, two weeks and three weeks after discharge for WeChat push or phone call; WeChat push, phone call and questionnaire.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Patients who meet the 2018 ADA medical standards for Diabetes diagnosis and treatment, are diagnosed with T2DM and use insulin or sulfonylurea drugs;
• Duration of diabetes mellitus ≥1 year
• Age ≥18 years old;
• A history of hypoglycemia in the past 6 months;
• Type 2 diabetes patients with hypoglycemia coping style questionnaire inclination, avoidance, compromise;
• Good communication and language skills;
• Have a smartphone and can use it;
• Voluntary participation in this study.

Exclusion Criteria

• Patients with type 1 diabetes;
• Patients with type 2 diabetes combined with serious complications;
• Patients who have recently or are participating in other similar studies.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Yating Liu

OTHER

Sponsor Role: lead

Responsible Party

Yating Liu

supervisor nurse

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Ya T Liu, Bachelor

Role: PRINCIPAL_INVESTIGATOR

Yangzhou University

Locations

Ya ting Liu

Yangzhou, 未选择, China

Countries

China

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

YZUHL20220047

Identifier Type: -

Identifier Source: org_study_id