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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06197360

Enrollment

Registered

2024-01-09

Start date

2021-08-01

Completion date

2022-01-31

Last updated

2025-02-10

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

Conditions

Fear of Hypoglycemia, Health Education, Impaired Awareness of Hypoglycemia, Self-Management, Type 2 Diabetes Mellitus

Keywords

Type 2 Diabetes Mellitus, Fear of hypoglycemia, Behavior Change Wheel theory, Impaired Awareness of Hypoglycemia, Self-Management

Brief summary

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.

Detailed description

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.

Interventions

BEHAVIORALBased on BCW Theory of Health Education

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.

BEHAVIORALGeneral 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Hypoglycemia Fear Behavioral	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.
Hypoglycemia Fear Worry	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

Measure	Time frame	Description
Gold Rating	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.
The Patients Assessment Chronic Illness Care( PACIC)	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.
The Self-management Attitude Scale for Diabetes Patients	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.

Countries

China

Participant flow

Pre-assignment details

Declined to participate (n= 11) Too busy (n= 3) Too sick (n= 2) Not interested (n= 6)

Participants by arm

Arm	Count
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. 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.	25
Based on BCW Theory of Health Education A FOH intervention program based on BCW theory was implemented on top of the control group. Based on BCW Theory of Health Education: 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.	25
Total	50

Baseline characteristics

Characteristic	Based on BCW Theory of Health Education	Total	General Diabetes Health Education
Age, Categorical <=18 years	1 Participants	3 Participants	2 Participants
Age, Categorical >=65 years	13 Participants	29 Participants	16 Participants
Age, Categorical Between 18 and 65 years	11 Participants	18 Participants	7 Participants
BMI（kg/m^2) <18.5	1 Participants	2 Participants	1 Participants
BMI（kg/m^2) 18.5~23.9	19 Participants	33 Participants	14 Participants
BMI（kg/m^2) 24~28	5 Participants	11 Participants	6 Participants
BMI（kg/m^2) ≥28	0 Participants	4 Participants	4 Participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment China	25 participants	50 participants	25 participants
Sex: Female, Male Female	15 Participants	31 Participants	16 Participants
Sex: Female, Male Male	10 Participants	19 Participants	9 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 25	0 / 25
other Total, other adverse events	0 / 25	0 / 25
serious Total, serious adverse events	0 / 25	0 / 25

Outcome results

Primary

Hypoglycemia Fear Behavioral

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.