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

Type 2 Diabetes Mellitus Clinical Trial

Official title:

Construction and Preliminary Verification of interventionImpact of an IMB Theory-based Health Education Intervention on Hypoglycemic Coping in Patients With Type 2 Diabetes: a Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06384118
• Other study ID #: YZUHL20220047
• Status: Completed
• Phase: N/A
• Start date: August 1, 2023
• Est. completion date: January 17, 2024

Study information

• Verified date: April 2024
• Source: Yangzhou University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: January 17, 2024
• Est. primary completion date: January 17, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Health Education
• Hypoglycemia
• Type 2 Diabetes Mellitus

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Ya ting Liu	Yangzhou	???

Sponsors (1)

Lead Sponsor	Collaborator
Yating Liu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	hypoglycemic fear behavioral	Hypoglycemia fear-behavior scale (HFS-BS) consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 to 95, with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia. The higher the score, the more obvious the change in the patient's hypoglycemic fear behavior and the higher the degree of hypoglycemic fear.	Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary	Hypoglycemia fear worry	Hypoglycemia fear survey-worry scale (HFS-WS) was used to assess the patients' feelings about hypoglycemia in the past six months. The scale has 13 entries, and adopts Likert's 5-point scale, with scores ranging from 0-4 from the lowest to the highest, and the total score ranging from 0 to 52, with the higher the score, the more fearful the patients are about hypoglycemia.	Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary	Level of health information access behavior	The Cronbach's alpha coefficient of the scale was 0.866, and a Likert 5-point scale was used, and a standardized score of the scale score (Index Score=(actual total score/possible highest score)*100%) of greater than 50% was considered moderately high. Higher scores represent higher levels of health information acquisition behavior.	Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary	Level of health beliefs	The questionnaire consisted of 20 items in 5 latitudes, mainly for the necessity of diabetes treatment, benefits, harms, hazards of diabetes, and motivation to maintain the health of the organism, and the Cronbach's alpha coefficient of the scale was 0.89, and the questionnaire was scored on a 5-point Likert scale, with 8 to 14 being inverse scores, and the higher the total score indicated that the patient's beliefs about health were stronger.	Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary	Level of diabetes knowledge	The Cronbach's alpha coefficient of the questionnaire was 0.909, and the factor rotation analysis extracted six main factors explaining basic knowledge , dietary knowledge, exercise knowledge, self-monitoring knowledge, medication knowledge and complication knowledge. The variance explained by individual factors was above 7%, and the cumulative variance contribution rate was 69.004%, indicating that the questionnaire had good internal consistency. The evaluation standard of the questionnaire was 1 point for a correct answer, 0 point for an incorrect or unclear answer, and the cumulative score of the 34 items was added to the total knowledge score, and the higher the score, the more knowledge about diabetes mellitus was acquired.	Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention