Type 2 Diabetes MellitusNCT06384118
Effects of a Health Intervention on Hypoglycemic Coping : a Pilot Study
A study testing Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study in people with Type 2 Diabetes Mellitus and Hypoglycemia, run by Yating Liu at 1 site in China.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes Mellitus, Hypoglycemia, Health Education
- What is being tested?
- Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2023to 17 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia, Health Education
- Being tested
- Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study
- Keywords
- type 2 diabetes mellitus, hypoglycemic, coping style, IMB theory
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypoglycemia, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot studyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Based on IMB Theory of Health Education A hypoglycemia coping intervention program based on IMB theory was implemented on top of the control group. Receives: Behavioral: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study |
| the control group | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
The hypoglycemic coping style
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Secondary outcomes (5)
hypoglycemic fear behavioral
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Hypoglycemia fear worry
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of health information access behavior
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of health beliefs
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Level of diabetes knowledge
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.
Measured: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start1 Aug 2023
- Primary completion17 Jan 2024
- Study completion17 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yating Liu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yating Liu, Yangzhou University
- Investigators
- Ya T Liu, Bachelor, Principal investigator, Yangzhou University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384118
- Sponsor's protocol ID
- YZUHL20220047
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06384118
- Acronym / sponsor ID
- YZUHL20220047
- Conditions
- Type 2 Diabetes Mellitus, Hypoglycemia, Health Education
- Keywords
- type 2 diabetes mellitus, hypoglycemic, coping style, IMB theory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Yating LiuUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 17 Jan 2024 (actual)
- Study completion
- 17 Jan 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot studyBased on IMB Theory of Health Education A hypoglycemia coping intervention program based on IMB theory was implemented on top of the control group. |
| the control group | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot studyBased 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. | Behavioural | intervention group |
Primary outcome
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.
5 secondary outcomes
hypoglycemic fear behavioral
Time frame: 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
Level of health information access behavior
Time frame: 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
Level of diabetes knowledge
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ya T Liu, Bachelor principal investigator
Yangzhou University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Impact of an IMB theory-based health education intervention on hypoglycemic coping in patients with type 2 diabetes: a pilot study in people with Type 2 Diabetes Mellitus and Hypoglycemia, run by Yating Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The hypoglycemic coping style (time frame: Baseline, 4 weeks, 8 weeks and 12 weeks post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024; AzTrials last refreshed its copy on 6 Nov 2026.