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Completed

NCT Number: NCT06197360

Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study

The purpose of this study was to construct a Fear of Hypoglycemia(FoH) intervention program for type 2 diabetic patients based on the Behaviour Change Wheel (BCW) theory and to investigate the feasibility, acceptability, and initial effects of the program.

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Key information

About this study

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on BCW 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 4-week follow-up period, for a total of 8 weeks.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Comply with the 2020 Chinese guidelines for the prevention and treatment of type 2 diabetes mellitus
  • Age ≥18 years
  • Duration of diabetes mellitus ≥1 year
  • FOH according to the elevated item endorsement criterion (E I criterion): ≥3 points on any item of the Hypoglycemic Fear-Worry Scale (HFS-WS)
  • Patients who have the ability to listen, read, write, walk, and cooperate to complete the study
  • Patients who have a smart phone, and can skillfully use WeChat or telephone to communicate
  • Voluntarily participate in this study and sign the informed consent form.

Exclusion criteria

  • Patients with comorbid acute complications or other serious diseases or disorders of consciousness, such as diabetic hypertonic state, tumors, coma, etc.
  • Patients with comorbid psychiatric diseases or taking psychotropic drugs
  • Patients who have recently or are participating in other studies on similar topics

Treatment and study plan

Based on BCW Theory of Health Education

Behavioral

Questionnaire collection, face-to-face interview, and interpretation of the manual on the first day of admission; diabetes self-management teaching on the second day; and hypoglycemia-related lectures and hands-on teaching on the fourth day. Day 6 hypoglycemia fear case discussion. Face-to-face teaching and formulation of blood glucose management plan on the first day before discharge; WeChat push or telephone return visit one week and two weeks after discharge; WeChat push, telephone return visit and questionnaire collection three weeks after discharge.

General diabetes health education

Behavioral

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.

Primary outcomes

  1. Hypoglycemia Fear Behavioral

    Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

    Hypoglycemia Fear Survey - Behavior Scale consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 (lowest) to 95 (highest), with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia.

  2. Hypoglycemia Fear Worry

    Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

    Hypoglycemic fear Survey - Worry Scale was used to evaluate the patients' hypoglycemic feelings in the past 6 months. There were 13 items in the scale, using 5-point Likert scale, with scores ranging from low to high 0-4, and the total score ranging from 0 (lowest) to 52 (highest). The higher the score, the higher the patient's fear of hypoglycemia.

Secondary outcomes

  1. Gold Rating

    Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

    Gold Score was first proposed by Professor Gold in the UK in 1994. It is the most commonly used assessment method for Impaired Awareness of Hypoglycemia, which reflects patients' awareness of hypoglycemia at the same time. The only question with this approach is, "Do you know when your low blood sugar started?" Likert scores 7 on a scale of "1" (always aware) to "7" (never aware), with an overall score from 1 (lowest) to 7 (highest). An overall score of 1-3 is considered normal hypoglycemic self-awareness, and a score of ≥4 indicates the presence of IAH.

  2. The Patients Assessment Chronic Illness Care( PACIC)

    Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

    The Patient Assessment Chronic Care Scale was developed with support from the Johnson Foundation to assess the quality of care provided by healthcare organizations. Patients use this scale to report their perceived level of medical support. The PACIC scale consists of five dimensions and 20 questions, each of which is rated on a 5-point Likert scale (1 to 5), with higher scores (close to 5) indicating greater support from healthcare professionals. The score for each dimension is calculated based on the average score of the items it contains, and the total table score is calculated based on the average score of all 20 items, with a minimum score of 1 and a maximum score of 5. Total scale score ≤1.75 is classified as low level of medical support; An overall average score of 1.75 to 3.5 indicates moderate medical support; Total mean score ≥3.5 was classified as high medical support.

  3. The Self-management Attitude Scale for Diabetes Patients

    Time frame: Baseline, immediately after the intervention and after the 4 weeks follow-up

    The Self-Management Attitude Scale for Diabetic Patients is a sub-scale of the Self-Management Knowledge, Attitude and Behavior Assessment Scale for Diabetic Patients compiled by the Chinese Center for Prevention and Control of Chronic Noncommunicable Diseases (CPCNCD). The scale included five items that assessed patients' attitudes toward diabetes health education, diet control, physical activity, medication adherence, and blood glucose monitoring. The 5-point Likert scale was used, with 1 indicating "very important" and 5 indicating "very unimportant", and the scores were divided into 0.2, 0.4, 0.6, 0.8 and 1.0 in order from low to high. The total score of the five items is the total self-management attitude score (range 1-5), and a score below 3.0 indicates a poor self-management attitude. A score of 3.0 to 4.25 indicates an average self-management attitude, while a score of 4.25 or above indicates a good self-management attitude.

Sponsors and collaborators

Lead sponsor

Yangzhou University

Other

Registry information

Official study title

Effects of a Health Education Intervention Based on the Behaviour Change Wheel on Fear of Hypoglycemia in Patients With Type 2 Diabetes Mellitus: a Pilot Study

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Jan 9, 2024
Registry last updated
Feb 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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