Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
Primary Purpose
Type 2 Diabetes
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Give incentives to patients based on their own HbA1c improvement
Give incentives to physician based on their patient's HbA1c improvement
Sponsored by
About this trial
This is an interventional health services research trial for Type 2 Diabetes focused on measuring Community management, incentives, Medication Adherence
Eligibility Criteria
Inclusion Criteria:
- Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
- 40 to 74 years old
- Diagnosis type 2 diabetes more than 6 months
- Take at least one kind of oral hypoglycemic medication(including insulin injection)
- Got treatment in community hospitals or follow up for more than 12 months
- Have medical insurance
- Stable condition with no adverse indication
- Participate in this study voluntarily and sign the inform consent from
Exclusion Criteria:
- Terminal illness
- Serious hearing and visual disorder
- Intend to receive selective surgery, to get pregnancy and breast feeding in three months
- Demnentia or communication disorders
- Mental disorders
- The paralyzed or the handicapped
- Expected survival time less than one-year
Sites / Locations
- Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
No Intervention
Arm Label
incentives to physicians
incentives to patients
incentives to both physicians and patients
Group with no incentives
Arm Description
Give incentives to physicians according to patients' HbA1c improvement
Give incentives to patients according to their HbA1c improvement
intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement
Outcomes
Primary Outcome Measures
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
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.
Secondary Outcome Measures
Self-report medication adherence
The investigators assess adherence with MMAS 8-item version and BMQ-specific.
Improvement of HbA1c
Score on the Diabetes Quality Of Life
MEMS cap data compared to PHQ-9 and AIS assessment
Full Information
NCT ID
NCT02330484
First Posted
December 24, 2014
Last Updated
December 31, 2014
Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ruijin Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02330484
Brief Title
Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
Official Title
Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Unknown status
Study Start Date
March 2014 (undefined)
Primary Completion Date
June 2015 (Anticipated)
Study Completion Date
June 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine
Collaborators
Ruijin Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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:
The study will be ended in 12 months
Patient's drop out of the study
Stopping taking oral hypoglycemic drugs
The diabetic condition worsen, needs surgery or hospitalization treatment
Frequency of severe hypoglycemia or other complications that can not continue the study
Death of the patient
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
Community management, incentives, Medication Adherence
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
incentives to physicians
Arm Type
Experimental
Arm Description
Give incentives to physicians according to patients' HbA1c improvement
Arm Title
incentives to patients
Arm Type
Experimental
Arm Description
Give incentives to patients according to their HbA1c improvement
Arm Title
incentives to both physicians and patients
Arm Type
Experimental
Arm Description
intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement
Arm Title
Group with no incentives
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Give incentives to patients based on their own HbA1c improvement
Intervention Description
Give incentives to patients based on their own HbA1c improvement
Intervention Type
Behavioral
Intervention Name(s)
Give incentives to physician based on their patient's HbA1c improvement
Intervention Description
Give incentives to physician based on their patient's HbA1c improvement
Primary Outcome Measure Information:
Title
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Self-report medication adherence
Description
The investigators assess adherence with MMAS 8-item version and BMQ-specific.
Time Frame
12 months
Title
Improvement of HbA1c
Time Frame
12 months
Title
Score on the Diabetes Quality Of Life
Time Frame
12 months
Title
MEMS cap data compared to PHQ-9 and AIS assessment
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Confirmed type 2 diabetes patients (ICD9) according to the medical record and patient's disease history
40 to 74 years old
Diagnosis type 2 diabetes more than 6 months
Take at least one kind of oral hypoglycemic medication(including insulin injection)
Got treatment in community hospitals or follow up for more than 12 months
Have medical insurance
Stable condition with no adverse indication
Participate in this study voluntarily and sign the inform consent from
Exclusion Criteria:
Terminal illness
Serious hearing and visual disorder
Intend to receive selective surgery, to get pregnancy and breast feeding in three months
Demnentia or communication disorders
Mental disorders
The paralyzed or the handicapped
Expected survival time less than one-year
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liebin Zhao, MSM
Organizational Affiliation
Shanghai Clinical Centre for Endocrinology and Metabolism
Official's Role
Study Chair
Facility Information:
Facility Name
Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200025
Country
China
12. IPD Sharing Statement
Learn more about this trial
Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
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