Type 2 DiabetesNCT02161094
Diabetes Incentive Performance Study (DIPS) at Shanghai Jiading District
A study testing Give incentives to physicians based on their patient's HbA1c improvement and Give incentives to patients based on their own HbA1c improvement in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial summary
Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the study seminar. Those physicians who meet the criteria of the study plan were being selected to participate voluntarily. Read more about this study
- Who is it for?
- Ages 40 to 74 years
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Give incentives to physicians based on their patient's HbA1c improvement and Give incentives to patients based on their own HbA1c improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,300 participants
- Where
- 1 siteChina
- Study dates
- Apr 2013to Mar 2016
- 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 40 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history；
- Diagnosis type 2 diabetes more than 6 months;
- Receive DM therapy and follow up in health community center for more than 12 years;
- Are insured for social health insurance system for treatment and medication reimbursement;
- agree to participate in the study and have signed the Inform Consent Form.
Who cannot join
- Terminal illness；
- Hearing loss or severe visual disorder;
- Planned to receive selective surgery within 3months;
- Are in Pregnancy or breast-feeding while study;
- Observed mental confusion suggesting dementia;
- Ongoing psychiatric care;
- Paralysis or residence in a long-term care facility;
- Life expectancy is less than 12 months.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Shanghai, Shanghai Municipality, 200025
About this study
Official title: Diabetes Incentive Performance Study（DIPS）at Shanghai Jiading District
Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the study seminar. Those physicians who meet the criteria of the study plan were being selected to participate voluntarily. From their patient's record, the physicians will recruit a total of 1300 patients with type 2 diabetes who meet the criteria of the Jiading Study.
The study utilizes the social learning theory that motivation and social support are important to make behavioral change. The mechanism of providing incentive for patients and physicians will be established after the permission from the Internal Review Board of the hospital and will be approved by the hospital director. Physicians and their patients were randomly divided into 4 groups: Group 1- Physicians only; Group 2 - Patients only; Group 3 - Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they can maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. The forth group serves as a control and will not receive any incentive but will be provided diabetes education booklet and group education courses for DM control as usual. Based on the annual evaluation of the level of improvement on HbA1c that is a joint effort of both patients and physicians to achieve the targeted goal of adequate HBA1c level, the value of incentives will be increased accordingly. Our ultimate goal is to evaluate the effectiveness of incentive as an intervention tool to improve the health status of the diabetic patients.
Read the detailed description
Methods：
This study is an open- label controlled randomized cluster trial and will invite eligible physicians and their patients to attend the study. These physicians work in health community center at Shanghai Jiading district and their patients are from the district community. Each physician should care and monitor at least 20 of his or her patients. This serves as a cluster randomized unit. The study size consists of 40 or more units within the Jiading District of Shanghai. Samples will taken from these patients according to the preset schedule and will measure patients' level of HbA1c accordingly. The physicians will recruit their patients who meet the criterion of the Jiading Study Standard. All of these patients have established their own health record by physicians in the community health center. To the enrolled patients, the study will obtain the information such as demographic characteristics, diagnosis and treatment, complications , various of biochemical index, skill and capacity of disease self-management, etc. Biomarkers and genetic risk factors will be evaluated in the study subjects. The study also will give several training courses to the enrolled physicians and the patients, all of them need to meet the study criteria and will sign the inform consent to participate in the study.
The study will use the method of randomized complete block design to classify the enrolled units into 4 groups. Group 1- Physicians only; Group 2 - Patients only; Group 3 - Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they can obtain or/and maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. We aim to achieve a target of HbA1c < 7% or to reduce 0.5% HbA1c level annually during 3 years study period. The incentive is in the form of cash or same value awards. The amount of the incentives will increase annually depending upon the change of HbA1c. The award is served as an motivation factor and token for rewarding the desire for self-discipline and disease management to enhance self-efficacy. The control group will not receive any incentives but will be provided diabetes education booklet and group education courses for DM control as usual.
The study will use the existing tele-medicine system to monitor patients' blood pressure and blood glucose remotely. The system of the telemedicine will also provide a series of diabetes education and training courses to support the physicians and the patients about the diabetes treatment, care and the self-management on the diseases. The study will document the changes on the patients' blood pressure, biochemical index, medication, quality of life, self-management skill of diabetes, life behavior, complications and costs.
Endpoint of the study:
The study will be ended in 36 months, endpoint measurement indicators are listed below:
- Withdraw rate: Patient who drop out from the study;
- Diabetic complication rate: Patient with new complications, such as macro- or micro-vascular complications;
- Admission rate due to diabetic related illness： Patient's diabetic condition worsen, needs to be hospitalized or surgery;
- Frequency of hypoglycemia incidences：Patient who has frequently severe hypoglycemia or other complications that can not continue the study;
- Mortality rate among enrolled patients Death.
- Conditions
- Type 2 Diabetes
- Being tested
- Give incentives to physicians based on their patient's HbA1c improvement, Give incentives to patients based on their own HbA1c improvement
- Keywords
- Community management incentives
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Give incentives to physicians based on their patient's HbA1c improvementBehavioural
Give incentives to patients based on their own HbA1c improvementBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Physicians | Experimental | Give incentives to physicians based on their patient's HbA1c improvement Receives: Behavioral: Give incentives to patients based on their own HbA1c improvement |
| Group 2: Diabetic patients | Experimental | Give incentives to patients based on their own HbA1c improvement Receives: Behavioral: Give incentives to physicians based on their patient's HbA1c improvement |
| Group 3: Both Physicians and Patients | Experimental | Give incentives to both based on the HbA1c improvements from the physicians' patients Receives: Behavioral: Give incentives to physicians based on their patient's HbA1c improvement; Behavioral: Give incentives to patients based on their own HbA1c improvement |
| Group 4: Control group | No intervention | Receive no incentive but will be provided diabetes education booklet and group education courses for DM control as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c
Measured: 36months
Secondary outcomes (8)
Fasting plasma glucose FPG
Measured: 36months
Fast serum insulin FINS
Measured: 36months
Metabolic parameters
Measured: 36months
Serum lipids
Measured: 36months
Urine protein
Measured: 36months
BMI
Measured: 36months
Blood pressure
Measured: 36 months
Score on the Diabetes Quality Of Life
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2014 (estimated)
- Study startApr 2013
- Primary completionMar 2016 (estimated)
- Study completionMar 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Ruijin Hospital
- Responsible party
- Principal investigator, Guang Ning, Shanghai Jiao Tong University School of Medicine
- Investigators
- Guang Ning, MD. PHD, Study chair, Shanghai Clinical Centre for Endocrinology and MetabolismLiebin Zhao, MSM, Study chair, Center of Diabetes, Ruijin Hospital, Shanghai JiaoTong University School of MedicineYuhong Chen, MD, Study chair, Shanghai Clinical Centre for Endocrinology and Metabolism, Ruijin Hospital, Shanghai JiaoTong University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02161094
- Sponsor's protocol ID
- CCEMD-019
- Status last verified
- Dec 2014
- First submitted
- 25 May 2014
- Last updated
- 3 Dec 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diabetes Incentive Performance Study（DIPS）at Shanghai Jiading District
- ClinicalTrials.gov ID
- NCT02161094
- Acronym / sponsor ID
- CCEMD-019
- Conditions
- Type 2 Diabetes
- Keywords
- Community management incentives
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,300 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- Apr 2013
- Primary completion
- Mar 2016 (estimated)
- Study completion
- Mar 2016 (estimated)
- First posted
- 11 Jun 2014 (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.
Objectives:Physicians from the Shanghai Jiading community clinic were invited to attend the study seminar. Those physicians who meet the criteria of the study plan were being selected to participate voluntarily. From their patient's record, the physicians will recruit a total of 1300 patients with type 2 diabetes who meet the criteria of the Jiading Study.
The study utilizes the social learning theory that motivation and social support are important to make behavioral change. The mechanism of providing incentive for patients and physicians will be established after the permission from the Internal Review Board of the hospital and will be approved by the hospital director. Physicians and their patients were randomly divided into 4 groups: Group 1- Physicians only; Group 2 - Patients only; Group 3 - Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they can maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. The forth group serves as a control and will not receive any incentive but will be provided diabetes education booklet and group education courses for DM control as usual. Based on the annual evaluation of the level of improvement on HbA1c that is a joint effort of both patients and physicians to achieve the targeted goal of adequate HBA1c level, the value of incentives will be increased accordingly. Our ultimate goal is to evaluate the effectiveness of incentive as an intervention tool to improve the health status of the diabetic patients.
Detailed description
Methods：
This study is an open- label controlled randomized cluster trial and will invite eligible physicians and their patients to attend the study. These physicians work in health community center at Shanghai Jiading district and their patients are from the district community. Each physician should care and monitor at least 20 of his or her patients. This serves as a cluster randomized unit. The study size consists of 40 or more units within the Jiading District of Shanghai. Samples will taken from these patients according to the preset schedule and will measure patients' level of HbA1c accordingly. The physicians will recruit their patients who meet the criterion of the Jiading Study Standard. All of these patients have established their own health record by physicians in the community health center. To the enrolled patients, the study will obtain the information such as demographic characteristics, diagnosis and treatment, complications , various of biochemical index, skill and capacity of disease self-management, etc. Biomarkers and genetic risk factors will be evaluated in the study subjects. The study also will give several training courses to the enrolled physicians and the patients, all of them need to meet the study criteria and will sign the inform consent to participate in the study.
The study will use the method of randomized complete block design to classify the enrolled units into 4 groups. Group 1- Physicians only; Group 2 - Patients only; Group 3 - Both Physicians and Patients, Group 4 - control. Groups 1-3 will receive incentives if they can obtain or/and maintain the ideal level of Hemoglobin A1c (HbA1c) during the 3-years study period. We aim to achieve a target of HbA1c < 7% or to reduce 0.5% HbA1c level annually during 3 years study period. The incentive is in the form of cash or same value awards. The amount of the incentives will increase annually depending upon the change of HbA1c. The award is served as an motivation factor and token for rewarding the desire for self-discipline and disease management to enhance self-efficacy. The control group will not receive any incentives but will be provided diabetes education booklet and group education courses for DM control as usual.
The study will use the existing tele-medicine system to monitor patients' blood pressure and blood glucose remotely. The system of the telemedicine will also provide a series of diabetes education and training courses to support the physicians and the patients about the diabetes treatment, care and the self-management on the diseases. The study will document the changes on the patients' blood pressure, biochemical index, medication, quality of life, self-management skill of diabetes, life behavior, complications and costs.
Endpoint of the study:
The study will be ended in 36 months, endpoint measurement indicators are listed below:
- Withdraw rate: Patient who drop out from the study;
- Diabetic complication rate: Patient with new complications, such as macro- or micro-vascular complications;
- Admission rate due to diabetic related illness： Patient's diabetic condition worsen, needs to be hospitalized or surgery;
- Frequency of hypoglycemia incidences：Patient who has frequently severe hypoglycemia or other complications that can not continue the study;
- Mortality rate among enrolled patients Death.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Physicians | Experimental | Behavioral: Give incentives to patients based on their own HbA1c improvementGive incentives to physicians based on their patient's HbA1c improvement |
| Group 2: Diabetic patients | Experimental | Behavioral: Give incentives to physicians based on their patient's HbA1c improvementGive incentives to patients based on their own HbA1c improvement |
| Group 3: Both Physicians and Patients | Experimental | Behavioral: Give incentives to physicians based on their patient's HbA1c improvement, Behavioral: Give incentives to patients based on their own HbA1c improvementGive incentives to both based on the HbA1c improvements from the physicians' patients |
| Group 4: Control group | No intervention | –Receive no incentive but will be provided diabetes education booklet and group education courses for DM control as usual |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history；
- Diagnosis type 2 diabetes more than 6 months;
- Receive DM therapy and follow up in health community center for more than 12 years;
- Are insured for social health insurance system for treatment and medication reimbursement;
- agree to participate in the study and have signed the Inform Consent Form.
Key exclusion criteria (8 listed)
- Terminal illness；
- Hearing loss or severe visual disorder;
- Planned to receive selective surgery within 3months;
- Are in Pregnancy or breast-feeding while study;
- Observed mental confusion suggesting dementia;
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 |
|---|---|---|
| Give incentives to physicians based on their patient's HbA1c improvement | Behavioural | Group 2: Diabetic patients, Group 3: Both Physicians and Patients |
| Give incentives to patients based on their own HbA1c improvement | Behavioural | Group 1: Physicians, Group 3: Both Physicians and Patients |
Primary outcome
Change in HbA1c
Time frame: 36months
8 secondary outcomes
Fasting plasma glucose FPG
Time frame: 36months
Fast serum insulin FINS
Time frame: 36months
Metabolic parameters
Time frame: 36months
Serum lipids
Time frame: 36months
Urine protein
Time frame: 36months
BMI
Time frame: 36months
Blood pressure
Time frame: 36 months
Score on the Diabetes Quality Of Life
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 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.
Guang Ning, MD. PHD study chair
Shanghai Clinical Centre for Endocrinology and Metabolism
Liebin Zhao, MSM study chair
Center of Diabetes, Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Yuhong Chen, MD study chair
Shanghai Clinical Centre for Endocrinology and Metabolism, Ruijin Hospital, Shanghai JiaoTong University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Give incentives to physicians based on their patient's HbA1c improvement and Give incentives to patients based on their own HbA1c improvement in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine 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 5 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 3 Dec 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 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?
Results are not available in the source record.
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?
Change in HbA1c (time frame: 36months). 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 3 Dec 2014.