Skip to content

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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06384118
Enrollment
100
Registered
2024-04-25
Start date
2023-08-01
Completion date
2024-01-17
Last updated
2024-04-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Education, Hypoglycemia, Type 2 Diabetes Mellitus

Keywords

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

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.

Interventions

BEHAVIORALImpact 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.

Sponsors

Yating Liu
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The hypoglycemic coping styleBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionThe 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.

Secondary

MeasureTime frameDescription
hypoglycemic fear behavioralBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionHypoglycemia 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.
Hypoglycemia fear worryBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionHypoglycemia 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.
Level of health information access behaviorBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionThe 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.
Level of health beliefsBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionThe 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.
Level of diabetes knowledgeBaseline, 4 weeks, 8 weeks and 12 weeks post-interventionThe 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.

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026