Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| General diabetes health education | Placebo Comparator | 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. |
|
| Based on BCW Theory of Health Education | Experimental | A FOH intervention program based on BCW theory was implemented on top of the control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, immediately after the intervention and after the 4 weeks follow-up |
| Hypoglycemia Fear Worry | 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. | Baseline, immediately after the intervention and after the 4 weeks follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Gold Rating | 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. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Yueqi Zhao, Bachelor | Yangzhou University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yangzhou University | Yangzhou | Jiangsu | 225000 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35788767 | Result | Zhong W, Lin L, Gong X, Chen Z, Chen Y, Yan S, Zhou Y, Zhang X, Hu H, Tong L, Cheng C, Gu Q, Chen Y, Yu X, Huang Y, Yuan C, Lou M; MISSION investigators. Evaluation of a multicomponent intervention to shorten thrombolytic door-to-needle time in stroke patients in China (MISSION): A cluster-randomized controlled trial. PLoS Med. 2022 Jul 5;19(7):e1004034. doi: 10.1371/journal.pmed.1004034. eCollection 2022 Jul. | |
| 40548996 |
Not provided
Not provided
No plans to provide IPD.
Not provided
Not provided
Not provided
Not provided
Declined to participate (n= 11) Too busy (n= 3) Too sick (n= 2) Not interested (n= 6)
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after the intervention and after the 4 weeks follow-up |
|
2 months
Evaluated through standardized questionnaires, regular assessments by researchers, and periodic laboratory inspections. No participants experienced adverse events.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Yueqi Zhao | Yangzhou University | 13390676131 | mz120221975@stu.yzu.edu.cn |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 14, 2021 | Dec 21, 2023 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006266 | Health Education |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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. |
|
| Baseline, immediately after the intervention and after the 4 weeks follow-up |
| The Patients Assessment Chronic Illness Care( PACIC) | 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. | Baseline, immediately after the intervention and after the 4 weeks follow-up |
| The Self-management Attitude Scale for Diabetes Patients | 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. | Baseline, immediately after the intervention and after the 4 weeks follow-up |
| Derived |
| Zhao Y, Zhang L, Pang J, Qiu J, He Y, Xu Z, Han M, Liu L, Wan X, Wang J, Zhang Y. Effects of a health education intervention based on the behavior change wheel on fear of hypoglycemia behavior in type 2 diabetes mellitus patients: a randomized controlled pilot trial. Acta Diabetol. 2025 Dec;62(12):2071-2084. doi: 10.1007/s00592-025-02549-5. Epub 2025 Jun 23. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI（kg/m^2) | Count of Participants | Participants |
|
| OG001 | 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. |
|
|
| Primary | Hypoglycemia Fear Worry | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after the intervention and after the 4 weeks follow-up |
|
|
|
| Secondary | Gold Rating | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after the intervention and after the 4 weeks follow-up |
|
|
|
| Secondary | The Patients Assessment Chronic Illness Care( PACIC) | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after the intervention and after the 4 weeks follow-up |
|
|
|
| Secondary | The Self-management Attitude Scale for Diabetes Patients | 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. | Posted | Mean | Standard Deviation | score on a scale | Baseline, immediately after the intervention and after the 4 weeks follow-up |
|
|
|
| 0 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
| EG001 | 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. | 0 | 25 | 0 | 25 | 0 | 25 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D000099060 | Adherence Interventions |
| D055118 | Medication Adherence |
| D010349 | Patient Compliance |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
| 24~28 |
|
| ≥28 |
|
| After the 4 weeks follow-up |
|
| After the 4 weeks follow-up |
|
| After the 4 weeks follow-up |
|
| After the 4 weeks follow-up |
|