Sponsor study identifier
interventional
50
1 country
1
Study Start
August 1, 2021
Actual (reported)Primary Completion
January 31, 2022
Actual (reported)Study Completion
January 31, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 31, 2022
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 1, 2021
Actual (reported)January 31, 2022
Actual (reported)January 31, 2022
Actual (reported)December 21, 2023
Actual (reported)January 9, 2024
Actual (reported)February 10, 2025
Actual (reported)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
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.
A FOH intervention program based on BCW theory was implemented on top of the control group.
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.
Yangzhou University
Yangzhou, Jiangsu, 225000, China
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.
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.
Yueqi Zhao, Bachelor
Yangzhou University
50 participants (actual enrollment reported by the registry).
First Submitted
December 21, 2023
First Posted
January 9, 2024
Study Start
August 1, 2021
Actual (reported)The Effect of Blood Flow Restriction Training on Glycemic Control Among Type 2 Diabetes Patients
Gold Rating
Baseline, immediately after the intervention and after the 4 weeks follow-up
The Patients Assessment Chronic Illness Care( PACIC)
Baseline, immediately after the intervention and after the 4 weeks follow-up
The Self-management Attitude Scale for Diabetes Patients
Baseline, immediately after the intervention and after the 4 weeks follow-up
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.
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Primary Completion
January 31, 2022
Actual (reported)Study Completion
January 31, 2022
Actual (reported)Last Updated
February 10, 2025
Results First Posted
February 10, 2025
Record last verified: 2025-01
No plans to provide IPD.
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Source: ClinicalTrials.gov.
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