Diabetes Incentive Performance Study (DIPS) at Shanghai Jiading District

NCT02161094 | Unknown DMC

• 1 other identifier: CCEMD-019
• Study Type: interventional
• Target: 1,300
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Type 2 Diabetes

Keywords

Community management incentives

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c

  36months

Secondary Outcomes (8)

• Fasting plasma glucose FPG

  36months

• Fast serum insulin FINS

  36months

• Metabolic parameters

  36months

• Serum lipids

  36months

• Urine protein

  36months

Study Arms (4)

Group 1: Physicians

EXPERIMENTAL

Give incentives to physicians based on their patient's HbA1c improvement

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

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

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

Interventions

Give incentives to physicians based on their patient's HbA1c improvement BEHAVIORAL

Group 2: Diabetic patients; Group 3: Both Physicians and Patients

Give incentives to patients based on their own HbA1c improvement BEHAVIORAL

Group 1: Physicians; Group 3: Both Physicians and Patients

Eligibility Criteria

• Age: 40 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Jiao Tong University School of Medicine: lead
• Ruijin Hospital: collaborator

Study Sites (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Guang Ning, MD. PHD

  Shanghai Clinical Centre for Endocrinology and Metabolism

  STUDY CHAIR

• Liebin Zhao, MSM

  Center of Diabetes, Ruijin Hospital, Shanghai JiaoTong University School of Medicine

  STUDY CHAIR

• Yuhong Chen, MD

  Shanghai Clinical Centre for Endocrinology and Metabolism, Ruijin Hospital, Shanghai JiaoTong University, School of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: May 25, 2014
• First Posted: June 11, 2014
• Study Start: April 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

CN (1)