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

Y

Yangzhou University

Status

Completed

Conditions

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

Treatments

Behavioral: General diabetes health education
Behavioral: Based on BCW Theory of Health Education

Study type

Interventional

Funder types

Other

Identifiers

NCT06197360
YZUHL20210088

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

All

Ages

18+ years old

Volunteers

No 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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

50 participants in 2 patient groups, including a placebo group

General diabetes health education
Placebo Comparator group
Description:
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.
Treatment:
Behavioral: General diabetes health education
Based on BCW Theory of Health Education
Experimental group
Description:
A FOH intervention program based on BCW theory was implemented on top of the control group.
Treatment:
Behavioral: Based on BCW Theory of Health Education

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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