CompletedNot Applicable

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

China50 participantsStarted 2021-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hypoglycemia Fear Behavioral

Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-up

Hypoglycemia Fear Worry

Timeframe: Baseline, immediately after the intervention and after the 4 weeks follow-up

Trial details

NCT IDNCT06197360

SponsorYangzhou University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-31

Results submitted2024-07-30

View on ClinicalTrials.gov More Type 2 Diabetes Mellitus trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.