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

NCT06384118 | Completed DMC

• 1 other identifier: YZUHL20220047
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus; Hypoglycemia; Health Education

Keywords

type 2 diabetes mellitus; hypoglycemic; coping style; IMB theory

Outcome Measures

Primary Outcomes (1)

• The hypoglycemic coping style

  The scale consists of 16 entries in 3 dimensions, which in this study are confrontation (entries 1, 6, 8, 11, 12, 15), avoidance (entries 2, 5, 7, 10, 13, 16), and submission (entries 3, 4, 9, 14), and each of the entries is rated on a Likert's 5 scale ranging from 0-4, with higher scores on the dimensions indicating a greater tendency toward this type of coping, and the scale's total Cronbach's alpha coefficient was 0.821.

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

Secondary Outcomes (5)

• hypoglycemic fear behavioral

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

• Hypoglycemia fear worry

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

• Level of health information access behavior

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

• Level of health beliefs

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

• Level of diabetes knowledge

  Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

Study Arms (2)

intervention group

EXPERIMENTAL

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

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

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.

Interventions

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

intervention group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yating Liu: lead

Study Sites (1)

Ya ting Liu

Yangzhou, 未选择, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypoglycemia; Health Education

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Ya T Liu, Bachelor

  Yangzhou University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: supervisor nurse

Study Record Dates

• First Submitted: January 17, 2024
• First Posted: April 25, 2024
• Study Start: August 1, 2023
• Primary Completion: January 17, 2024
• Study Completion: January 17, 2024
• Last Updated: April 25, 2024

Record last verified: 2024-04

Locations

CN (1)