Clinical trial NCT06197360: Effects of a Health Intervention on Fear of Hypoglycemia : a Pilot Study
Official 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Fear of Hypoglycemia
Health Education
Impaired Awareness of Hypoglycemia
Self-Management
Keywords: Type 2 Diabetes Mellitus
Fear of hypoglycemia
Behavior Change Wheel theory
Impaired Awareness of Hypoglycemia
Self-Management
Lead sponsor: Yangzhou University
Sponsor class: OTHER
First posted: 2024-01-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: Hypoglycemia Fear Behavioral
timeFrame: Baseline, immediately after the intervention and after the 4 weeks follow-up
measure: Hypoglycemia Fear Worry
timeFrame: Baseline, immediately after the intervention and after the 4 weeks follow-up
Secondary outcomes:
measure: Gold Rating
timeFrame: Baseline, immediately after the intervention and after the 4 weeks follow-up
measure: The Patients Assessment Chronic Illness Care( PACIC)
timeFrame: Baseline, immediately after the intervention and after the 4 weeks follow-up
measure: The Self-management Attitude Scale for Diabetes Patients
timeFrame: Baseline, immediately after the intervention and after the 4 weeks follow-up
Other outcomes:
Locations:
city: Yangzhou
country: China
facility: Yangzhou University
state: Jiangsu
Study officials:
affiliation: Yangzhou University
name: Yueqi Zhao, Bachelor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.