Trial Outcomes & Findings for Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study (NCT NCT06197360)
NCT ID: NCT06197360
Last Updated: 2025-02-10
Results Overview
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.
COMPLETED
NA
50 participants
Baseline, immediately after the intervention and after the 4 weeks follow-up
2025-02-10
Participant Flow
Declined to participate (n= 11) Too busy (n= 3) Too sick (n= 2) Not interested (n= 6)
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
25
|
25
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
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Age, Categorical
<=18 years
|
2 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
3 Participants
n=50 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=25 Participants
|
11 Participants
n=25 Participants
|
18 Participants
n=50 Participants
|
|
Age, Categorical
>=65 years
|
16 Participants
n=25 Participants
|
13 Participants
n=25 Participants
|
29 Participants
n=50 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=25 Participants
|
15 Participants
n=25 Participants
|
31 Participants
n=50 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=25 Participants
|
10 Participants
n=25 Participants
|
19 Participants
n=50 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
China
|
25 participants
n=25 Participants
|
25 participants
n=25 Participants
|
50 participants
n=50 Participants
|
|
BMI（kg/m^2)
<18.5
|
1 Participants
n=25 Participants
|
1 Participants
n=25 Participants
|
2 Participants
n=50 Participants
|
|
BMI（kg/m^2)
18.5~23.9
|
14 Participants
n=25 Participants
|
19 Participants
n=25 Participants
|
33 Participants
n=50 Participants
|
|
BMI（kg/m^2)
24~28
|
6 Participants
n=25 Participants
|
5 Participants
n=25 Participants
|
11 Participants
n=50 Participants
|
|
BMI（kg/m^2)
≥28
|
4 Participants
n=25 Participants
|
0 Participants
n=25 Participants
|
4 Participants
n=50 Participants
|
PRIMARY outcome
Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-upHypoglycemia 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.
Outcome measures
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
|
|---|---|---|
|
Hypoglycemia Fear Behavioral
Baseline
|
59.60 score on a scale
Standard Deviation 11.61
|
63.88 score on a scale
Standard Deviation 11.63
|
|
Hypoglycemia Fear Behavioral
Immediately after the intervention
|
57.52 score on a scale
Standard Deviation 12.33
|
44.20 score on a scale
Standard Deviation 5.59
|
|
Hypoglycemia Fear Behavioral
After the 4 weeks follow-up
|
55.16 score on a scale
Standard Deviation 10.68
|
39.72 score on a scale
Standard Deviation 5.34
|
PRIMARY outcome
Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-upHypoglycemic 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.
Outcome measures
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
|
|---|---|---|
|
Hypoglycemia Fear Worry
Baseline
|
32.72 score on a scale
Standard Deviation 4.09
|
32.96 score on a scale
Standard Deviation 2.89
|
|
Hypoglycemia Fear Worry
Immediately after the intervention
|
29.76 score on a scale
Standard Deviation 2.64
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18.76 score on a scale
Standard Deviation 3.63
|
|
Hypoglycemia Fear Worry
After the 4 weeks follow-up
|
27.16 score on a scale
Standard Deviation 4.15
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15.44 score on a scale
Standard Deviation 3.38
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SECONDARY outcome
Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-upGold 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.
Outcome measures
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
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|---|---|---|
|
Gold Rating
Baseline
|
2.84 score on a scale
Standard Deviation 1.28
|
2.88 score on a scale
Standard Deviation 1.26
|
|
Gold Rating
Immediately after the intervention
|
2.32 score on a scale
Standard Deviation 1.07
|
1.68 score on a scale
Standard Deviation 0.69
|
|
Gold Rating
After the 4 weeks follow-up
|
1.84 score on a scale
Standard Deviation 0.90
|
1.28 score on a scale
Standard Deviation 0.46
|
SECONDARY outcome
Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-upThe 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.
Outcome measures
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
|
|---|---|---|
|
The Patients Assessment Chronic Illness Care( PACIC)
Baseline
|
3.42 score on a scale
Standard Deviation 0.45
|
3.40 score on a scale
Standard Deviation 0.45
|
|
The Patients Assessment Chronic Illness Care( PACIC)
Immediately after the intervention
|
3.69 score on a scale
Standard Deviation 0.34
|
4.45 score on a scale
Standard Deviation 0.26
|
|
The Patients Assessment Chronic Illness Care( PACIC)
After the 4 weeks follow-up
|
3.55 score on a scale
Standard Deviation 0.41
|
4.46 score on a scale
Standard Deviation 0.21
|
SECONDARY outcome
Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-upThe 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.
Outcome measures
| Measure |
General Diabetes Health Education
n=25 Participants
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.
|
Based on BCW Theory of Health Education
n=25 Participants
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.
|
|---|---|---|
|
The Self-management Attitude Scale for Diabetes Patients
Baseline
|
3.91 score on a scale
Standard Deviation 0.68
|
4.10 score on a scale
Standard Deviation 0.58
|
|
The Self-management Attitude Scale for Diabetes Patients
Immediately after the intervention
|
4.21 score on a scale
Standard Deviation 0.53
|
4.78 score on a scale
Standard Deviation 0.18
|
|
The Self-management Attitude Scale for Diabetes Patients
After the 4 weeks follow-up
|
4.28 score on a scale
Standard Deviation 0.45
|
4.83 score on a scale
Standard Deviation 0.19
|
Adverse Events
General Diabetes Health Education
Based on BCW Theory of Health Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place