Diabetes MellitusNCT02977130
The Influence of Conversation Map on the Health Behaviors of Diabetes Patients
A study testing Map group in people with Diabetes Mellitus and Health Knowledge, Attitudes, Practice, run by National Taiwan University Hospital.
Trial summary
The American Diabetes Association indicates that diabetes self-management is a skill that diabetic patients must learn in the Diabetes Self-Management Education; thus, this contributes to shared care for diabetes, in which teams of physicians, professional nurses, and dietitians offer shared care to patients. Read more about this study
- Who is it for?
- Ages 30 to 80 years
- Conditions the study is for
- Diabetes Mellitus, Health Knowledge, Attitudes, Practice, Health Behavior
- What is being tested?
- Map group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 615 participants
- Where
- No sites listed yet
- Study dates
- May 2014to Jan 2015
- 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 30 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 2 diabetes mellitus between 30 and 80 years of age who participated in a diabetes shared-care program.
Who cannot join
- Patients were excluded if they had renal insufficiency (eGFR <30 mL•min / 1.732), were not ambulatory, or were unable to answer the questionnaire independently.
About this study
The American Diabetes Association indicates that diabetes self-management is a skill that diabetic patients must learn in the Diabetes Self-Management Education; thus, this contributes to shared care for diabetes, in which teams of physicians, professional nurses, and dietitians offer shared care to patients. However, according to the statistical analysis of the conditions of glycemic control in diabetic patients in 28 countries across 4 continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among diabetic patients in a shared-care program found that the percentage of patients with HbA1c lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1% during that period. These results suggest that despite the increase in the proportion of patients who successfully managed their diabetes, some patients still encountered difficulty in glycemic control.Therefore, numerous health education tools on diabetes continue to be developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial influence on the dietary habits of diabetic patients, and that individual health education had the largest effect on diabetes control. In addition, using the conversation map for diabetes control also had a substantial influence on improving health behaviors. Among existing studies that have adopted the conversation map, no large-scale research has been conducted, the research samples and relevant studies in Taiwan have been scant, and no theoretical foundation has been applied in evaluating the effects of the conversation map. Accordingly, the investigators aimed to enhance the mutual experience exchange and learning among diabetic patients through adopting the conversation map to observe its influence on their health behaviors by incorporating it into existing health education modalities. Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed for assessing the effectiveness of glycemic control in diabetic patients.
- Conditions
- Diabetes Mellitus, Health Knowledge, Attitudes, Practice, Health Behavior, Glycated Hemoglobin (HbA1c)
- Being tested
- Map group, Control group
- Medical subject headings
- Diabetes Mellitus, Behavior, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Map groupBehavioural
diabetes shared care plus conversation map intervention
Control groupBehavioural
diabetes shared care
| Study group | Role | What they receive |
|---|---|---|
| Map group | Experimental | patients receiving general shared care for diabetes and the conversation map intervention Receives: Behavioral: Map group |
| Control group | Active comparator | patients receiving general shared care for diabetes Receives: Behavioral: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Diet- and exercise-related health behaviors
Measured: 3 months
Glycated hemoglobin (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 posted30 Nov 2016 (estimated)
- Study startMay 2014
- Primary completionJan 2015
- Study completionJan 2015
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 National Taiwan University 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 615 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Sponsor
- Investigators
- Jiun-Hau Huang, SM, ScD, Principal investigator, National Taiwan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02977130
- Sponsor's protocol ID
- 201404062RINB
- Status last verified
- Nov 2016
- First submitted
- 24 Nov 2016
- Last updated
- 30 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Conversation Map on the Health Behaviors of Diabetes Patients
- ClinicalTrials.gov ID
- NCT02977130
- Acronym / sponsor ID
- 201404062RINB
- Conditions
- Diabetes Mellitus, Health Knowledge, Attitudes, Practice, Health Behavior, Glycated Hemoglobin (HbA1c)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 615 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- May 2014
- Primary completion
- Jan 2015 (actual)
- Study completion
- Jan 2015 (actual)
- First posted
- 30 Nov 2016 (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.
The American Diabetes Association indicates that diabetes self-management is a skill that diabetic patients must learn in the Diabetes Self-Management Education; thus, this contributes to shared care for diabetes, in which teams of physicians, professional nurses, and dietitians offer shared care to patients. However, according to the statistical analysis of the conditions of glycemic control in diabetic patients in 28 countries across 4 continents (Asia, Africa, Europe, and South America), the mean glycated hemoglobin (HbA1c) of the 12,727 patients was 9.5% by Litwak et al. in 2013. In Taiwan, a national survey among diabetic patients in a shared-care program found that the percentage of patients with HbA1c lower than 7% increased by 6.5% from 2006 to 2011; yet, among the 720 patients who completed both surveys in 2006 and 2011, the percentage with HbA1c lower than 7% decreased by 2.1% during that period. These results suggest that despite the increase in the proportion of patients who successfully managed their diabetes, some patients still encountered difficulty in glycemic control.Therefore, numerous health education tools on diabetes continue to be developed. In 2011,JoAnn et al. determined that the mode of health care had a substantial influence on the dietary habits of diabetic patients, and that individual health education had the largest effect on diabetes control. In addition, using the conversation map for diabetes control also had a substantial influence on improving health behaviors. Among existing studies that have adopted the conversation map, no large-scale research has been conducted, the research samples and relevant studies in Taiwan have been scant, and no theoretical foundation has been applied in evaluating the effects of the conversation map. Accordingly, the investigators aimed to enhance the mutual experience exchange and learning among diabetic patients through adopting the conversation map to observe its influence on their health behaviors by incorporating it into existing health education modalities. Furthermore, on the basis of the Health Belief Model, a relevant questionnaire was designed for assessing the effectiveness of glycemic control in diabetic patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Map group | Experimental | Behavioral: Map grouppatients receiving general shared care for diabetes and the conversation map intervention |
| Control group | Active comparator | Behavioral: Control grouppatients receiving general shared care for diabetes |
Who may qualify
- Ages
- 30 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with type 2 diabetes mellitus between 30 and 80 years of age who participated in a diabetes shared-care program.
Key exclusion criteria (1 listed)
- Patients were excluded if they had renal insufficiency (eGFR <30 mL•min / 1.732), were not ambulatory, or were unable to answer the questionnaire independently.
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 |
|---|---|---|
| Map groupdiabetes shared care plus conversation map intervention | Behavioural | Map group |
| Control groupdiabetes shared care | Behavioural | Control group |
Primary outcome
Diet- and exercise-related health behaviors
Time frame: 3 months
Glycated hemoglobin (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 30 Nov 2016.
- Individual participant dataSharing planned: No
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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.
Jiun-Hau Huang, SM, ScD principal investigator
National Taiwan University
Questions about this trial
What is this clinical trial studying?
A study testing Map group in people with Diabetes Mellitus and Health Knowledge, Attitudes, Practice, run by National Taiwan University Hospital.
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 1 inclusion and 1 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 30 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Diet- and exercise-related health behaviors (time frame: 3 months). The study lists 2 primary outcomes in all. 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 30 Nov 2016; AzTrials last refreshed its copy on 8 Nov 2026.