Diabetes MellitusEGVDNCT01917227
Evaluation of Group Health Teaching With Video in Diabetic Patients
A study testing Video in people with Diabetes Mellitus, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment. Method: Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled. Experimental Design and Methods: 1. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Video
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2013to Jun 2014
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing to sign the informed consent
- Age over 20 years old
- HbA1c>8% or PPG) > 200 mg/dl even under insulin therapy
Who cannot join
- Vegetation status
- Inability of visual or hearing contact with the video program
Trial locations and contacts
1 site in 1 country.
About this study
Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment.
Method:
Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled.
Experimental Design and Methods:
- Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial glucose (PPG)
- At the time of the visits, invite the patient to participate in the Video group education on insulin therapy By answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.
Read the detailed description
Diabetes is a long-term chronic disease. The patients need to correct "knowledge and action" lifestyle in order to achieve effective blood glucose control. Upon the general control of diabetic patients in Taiwan, however, glycosylated hemoglobin (HbA1c) is not satisfactory. One of the important reasons is the low rate of insulin injection. For the use of insulin, the patient has many misconception. The patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. So we hope that in this part of the health education activities through organized groups Videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.
- Conditions
- Diabetes Mellitus
- Being tested
- Video
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VideoBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Video | Experimental | Not described Receives: Behavioral: Video |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2013 (estimated)
- Study startJul 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, CHIA-HUNG LIN, Chang Gung Memorial Hospital
- Investigators
- CHIA-HUNG LIN, M.D., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01917227
- Sponsor's protocol ID
- 102-1452B
- Acronym
- EGVD
- Status last verified
- Jun 2014
- First submitted
- 26 Jul 2013
- Last updated
- 10 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Group Health Teaching With Video in Diabetic Patients
- ClinicalTrials.gov ID
- NCT01917227
- Acronym / sponsor ID
- EGVD / 102-1452B
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 6 Aug 2013 (estimated)
- 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.
Objective:Health videos and group education to allow patients to a correct understanding of diabetes and insulin treatment.
Method:
Standards and number of patients: The patients received subcutaneous insulin injection, estimated 30 people enrolled.
Experimental Design and Methods:
- Screening out-patient treatment with insulin use, HbA1c> 8% or poor postprandial glucose (PPG)
- At the time of the visits, invite the patient to participate in the Video group education on insulin therapy By answering some questions about insulin injections, such as: do not know how to perform; afraid of the pain; fear of inconvenience, give patients time to complete the questionnaire.
Detailed description
Diabetes is a long-term chronic disease. The patients need to correct "knowledge and action" lifestyle in order to achieve effective blood glucose control. Upon the general control of diabetic patients in Taiwan, however, glycosylated hemoglobin (HbA1c) is not satisfactory. One of the important reasons is the low rate of insulin injection. For the use of insulin, the patient has many misconception. The patients in the clinic need to spend a lot of time to explain and description, but the results are not necessarily good. So we hope that in this part of the health education activities through organized groups Videos to assist doctors and patients as a bridge of communication, to enhance diabetes doctor thus contributing to glycemic control results.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Video | Experimental | Behavioral: Video |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Willing to sign the informed consent
- Age over 20 years old
- HbA1c>8% or PPG) > 200 mg/dl even under insulin therapy
Key exclusion criteria (2 listed)
- Vegetation status
- Inability of visual or hearing contact with the video program
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 |
|---|---|---|
| Video | Behavioural | Video |
Primary outcome
HbA1c
Time frame: 3 months
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 10 Jun 2014.
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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.
CHIA-HUNG LIN, M.D. principal investigator
Chang Gung Memorial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video in people with Diabetes Mellitus, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
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 3 inclusion and 2 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 10 Jun 2014. 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 Taiwan. 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?
HbA1c (time frame: 3 months). 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 10 Jun 2014.