Overview

This trial is active, not recruiting.

Condition type 2 diabetes
Treatments give incentives to patients based on their own hba1c improvement, give incentives to physician based on their patient's hba1c improvement
Sponsor Shanghai Jiao Tong University School of Medicine
Collaborator Ruijin Hospital
Start date March 2014
End date June 2015
Trial size 400 participants
Trial identifier NCT02330484, CCEMD-026

Summary

Based on patients' HbA1c improvement, this study aims to establish an incentive strategy to family physicians and patients respectively to evaluate the affect on the adherence to medication among patients with type2 diabetes.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Experimental)
Give incentives to physicians according to patients' HbA1c improvement
give incentives to physician based on their patient's hba1c improvement
Give incentives to physician based on their patient's HbA1c improvement
(Experimental)
Give incentives to patients according to their HbA1c improvement
give incentives to patients based on their own hba1c improvement
Give incentives to patients based on their own HbA1c improvement
(Experimental)
intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement
give incentives to patients based on their own hba1c improvement
Give incentives to patients based on their own HbA1c improvement
give incentives to physician based on their patient's hba1c improvement
Give incentives to physician based on their patient's HbA1c improvement
(No Intervention)

Primary Outcomes

Measure
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
time frame: 12 months

Secondary Outcomes

Measure
Self-report medication adherence
time frame: 12 months
Improvement of HbA1c
time frame: 12 months
Score on the Diabetes Quality Of Life
time frame: 12 months
MEMS cap data compared to PHQ-9 and AIS assessment
time frame: 12 months

Eligibility Criteria

Male or female participants from 40 years up to 74 years old.

Inclusion Criteria: 1. Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history 2. 40 to 74 years old 3. Diagnosis type 2 diabetes more than 6 months 4. Take at least one kind of oral hypoglycemic medication(including insulin injection) 5. Got treatment in community hospitals or follow up for more than 12 months 6. Have medical insurance 7. Stable condition with no adverse indication 8. Participate in this study voluntarily and sign the inform consent from Exclusion Criteria: 1. Terminal illness 2. Serious hearing and visual disorder 3. Intend to receive selective surgery, to get pregnancy and breast feeding in three months 4. Demnentia or communication disorders 5. Mental disorders 6. The paralyzed or the handicapped 7. Expected survival time less than one-year

Additional Information

Official title Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
Description First step: In this study, the investigators will conduct an open-label controlled randomized cluster trial to enroll 400 eligible and voluntary patients with type 2 diabetes from the community. 16 physicians will be involved in this study for patient management. Each physician will care at least 20 patients as a random unit which will be divided into 4 groups for baseline assessment including demographic characteristics, diabetes diagnosis and treatment, complication, biochemical indexes and self-management. The involved patients and physicians will receive related training. The patients will sign the informed consent form. Second step: This study aims to give incentives to physicians or patients or both the physicians and patients based on HbA1c improvement. All the patients will sign the informed consent form. Regarding to the control group, health courses and community management will be given as usual. the investigators will evaluate the condition of patients' medication adherence after giving the incentives. Third step: MEMS will be used in the intervention to monitoring patients' medication adherence. As a monitoring instrument, MEMS (Aardex, Zurich, Switzerland) is a plastic container with a spring-loaded device in the cap. Each time the bottles is opened for at least 3 seconds, the time and date of opening are recorded and saved. Based on the research data and the HbA1c improvement, this study will analyze the other factors which affect the patients' adherence to medication. Meanwhile, the investigators will collect patients' information such as blood pressure, biochemical index, complications related to diabetes, life quality, self-management, life style, health behavior, medications, health expenditure so as to evaluate the affect of incentive strategy on the adherence to medication among patients with type 2 diabetes. Endpoint of the study: The study will be ended in 12 months, endpoint measurement indicators are listed below: 1. The study will be ended in 12 months 2. Patient's drop out of the study 3. Stopping taking oral hypoglycemic drugs 4. The diabetic condition worsen, needs surgery or hospitalization treatment 5. Frequency of severe hypoglycemia or other complications that can not continue the study 6. Death of the patient
Trial information was received from ClinicalTrials.gov and was last updated in December 2014.
Information provided to ClinicalTrials.gov by Shanghai Jiao Tong University School of Medicine.