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

Yating Liu

Status: Completed

Conditions: Hypoglycemia; Type 2 Diabetes Mellitus; Health Education

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

Study type: Interventional

Funder types: Other

Identifiers

NCT06384118

YZUHL20220047

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

intervention group

Experimental group

Description:

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

Treatment:

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

the control group

No Intervention group

Description:

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.