Clinical trial NCT02330484: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Type 2 Diabetes
Keywords: Community management， incentives, Medication Adherence
Lead sponsor: Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
First posted: 2015-01-05
Enrollment: 400
Sex: ALL
Minimum age (years): 40
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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:

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

Eligibility criteria: 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

Primary outcomes:
measure: Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
timeFrame: 12 months
Secondary outcomes:
measure: Self-report medication adherence
timeFrame: 12 months
measure: Improvement of HbA1c
timeFrame: 12 months
measure: Score on the Diabetes Quality Of Life
timeFrame: 12 months
measure: MEMS cap data compared to PHQ-9 and AIS assessment
timeFrame: 12 months
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin hospital, Shanghai Jiao-Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Shanghai Clinical Centre for Endocrinology and Metabolism
name: Liebin Zhao, MSM
role: STUDY_CHAIR
References: