Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study

April 22, 2024 updated by: Yating Liu

Construction and Preliminary Verification of interventionImpact of an IMB Theory-based Health Education Intervention on Hypoglycemic Coping in Patients With Type 2 Diabetes: a Pilot Study

From August 2023 to January 2024, 100 patients with type 2 diabetes who met the inclusion and exclusion criteria were selected from the endocrinology department of The purpose of this study was to construct a hypoglycemia coping intervention program for type 2 diabetic patients based on the IMB theory and to investigate the feasibility, acceptability, and initial effects of the program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In this study, eligible participants were randomized in a 1:1 ratio into an intervention group (health education based on IMB 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 8-week follow-up period, for a total of 12 weeks.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • 未选择
      • Yangzhou, 未选择, China
        • Ya ting Liu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Patients who meet the 2018 ADA medical standards for Diabetes diagnosis and treatment, are diagnosed with T2DM and use insulin or sulfonylurea drugs;
  • Duration of diabetes mellitus ≥1 year
  • Age ≥18 years old;
  • A history of hypoglycemia in the past 6 months;
  • Type 2 diabetes patients with hypoglycemia coping style questionnaire inclination, avoidance, compromise;
  • Good communication and language skills;
  • Have a smartphone and can use it;
  • Voluntary participation in this study.

Exclusion Criteria:

  • Patients with type 1 diabetes;
  • Patients with type 2 diabetes combined with serious complications;
  • Patients who have recently or are participating in other similar studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: intervention group
Based on IMB Theory of Health Education A hypoglycemia coping intervention program based on IMB theory was implemented on top of the control group.
Behavioral: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study
Based on IMB health education theory Questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; questionnaire collection, face-to-face interview, and manual interpretation on the first day of admission; hypoglycemia knowledge promotion on the second day; Peer experience sharing on the third day; access to WeChat group and knowledge pushing on the fourth day; hypoglycemia-related lectures and practical teaching on the fifth day, face-to-face teaching and development of blood glucose management plan. Hypoglycemia knowledge contest on the day before discharge; One week, two weeks and three weeks after discharge for WeChat push or phone call; WeChat push, phone call and questionnaire.
No Intervention: the control group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The hypoglycemic coping style
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
The scale consists of 16 entries in 3 dimensions, which in this study are confrontation (entries 1, 6, 8, 11, 12, 15), avoidance (entries 2, 5, 7, 10, 13, 16), and submission (entries 3, 4, 9, 14), and each of the entries is rated on a Likert's 5 scale ranging from 0-4, with higher scores on the dimensions indicating a greater tendency toward this type of coping, and the scale's total Cronbach's alpha coefficient was 0.821.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoglycemic fear behavioral
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Hypoglycemia fear-behavior scale (HFS-BS) consists of 19 entries and is scored on a 5-point Likert scale from 1 to 5, with total scores ranging from 15 to 95, with the higher scores indicating that the patients' hypoglycemia fear-behavior is more pronounced, and the higher the level of fear of hypoglycemia. The higher the score, the more obvious the change in the patient's hypoglycemic fear behavior and the higher the degree of hypoglycemic fear.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Hypoglycemia fear worry
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Hypoglycemia fear survey-worry scale (HFS-WS) was used to assess the patients' feelings about hypoglycemia in the past six months. The scale has 13 entries, and adopts Likert's 5-point scale, with scores ranging from 0-4 from the lowest to the highest, and the total score ranging from 0 to 52, with the higher the score, the more fearful the patients are about hypoglycemia.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of health information access behavior
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
The Cronbach's alpha coefficient of the scale was 0.866, and a Likert 5-point scale was used, and a standardized score of the scale score (Index Score=(actual total score/possible highest score)*100%) of greater than 50% was considered moderately high. Higher scores represent higher levels of health information acquisition behavior.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of health beliefs
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
The questionnaire consisted of 20 items in 5 latitudes, mainly for the necessity of diabetes treatment, benefits, harms, hazards of diabetes, and motivation to maintain the health of the organism, and the Cronbach's alpha coefficient of the scale was 0.89, and the questionnaire was scored on a 5-point Likert scale, with 8 to 14 being inverse scores, and the higher the total score indicated that the patient's beliefs about health were stronger.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of diabetes knowledge
Time Frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
The Cronbach's alpha coefficient of the questionnaire was 0.909, and the factor rotation analysis extracted six main factors explaining basic knowledge , dietary knowledge, exercise knowledge, self-monitoring knowledge, medication knowledge and complication knowledge. The variance explained by individual factors was above 7%, and the cumulative variance contribution rate was 69.004%, indicating that the questionnaire had good internal consistency. The evaluation standard of the questionnaire was 1 point for a correct answer, 0 point for an incorrect or unclear answer, and the cumulative score of the 34 items was added to the total knowledge score, and the higher the score, the more knowledge about diabetes mellitus was acquired.
Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yating Liu

Investigators

  • Principal Investigator: Ya T Liu, Bachelor, Yangzhou University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2023

Primary Completion (Actual)

January 17, 2024

Study Completion (Actual)

January 17, 2024

Study Registration Dates

First Submitted

January 17, 2024

First Submitted That Met QC Criteria

April 22, 2024

First Posted (Actual)

April 25, 2024

Study Record Updates

Last Update Posted (Actual)

April 25, 2024

Last Update Submitted That Met QC Criteria

April 22, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YZUHL20220047

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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