Type 2 DiabetesNCT02330484
Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
A study testing Give incentives to patients based on their own HbA1c improvement and Give incentives to physician based on their patient's HbA1c improvement in people with Type 2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
Trial 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. 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 patients based on their own HbA1c improvement and Give incentives to physician based on their patient's HbA1c improvement
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- Mar 2014to Jun 2015
- 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
- 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
Who cannot join
- 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
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
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.
Read the 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
- Conditions
- Type 2 Diabetes
- Being tested
- Give incentives to patients based on their own HbA1c improvement, Give incentives to physician based on their patient's HbA1c improvement
- Keywords
- Community management， incentives, Medication Adherence
- Medical subject headings
- Diabetes Mellitus, Type 2, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Give incentives to patients based on their own HbA1c improvementBehavioural
Give incentives to patients based on their own HbA1c improvement
Give incentives to physician based on their patient's HbA1c improvementBehavioural
Give incentives to physician based on their patient's HbA1c improvement
| Study group | Role | What they receive |
|---|---|---|
| incentives to physicians | Experimental | Give incentives to physicians according to patients' HbA1c improvement Receives: Behavioral: Give incentives to physician based on their patient's HbA1c improvement |
| incentives to patients | Experimental | Give incentives to patients according to their HbA1c improvement Receives: Behavioral: Give incentives to patients based on their own HbA1c improvement |
| incentives to both physicians and patients | Experimental | intervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement Receives: Behavioral: Give incentives to patients based on their own HbA1c improvement; Behavioral: Give incentives to physician based on their patient's HbA1c improvement |
| Group with no incentives | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (4)
Self-report medication adherence
The investigators assess adherence with MMAS 8-item version and BMQ-specific.
Measured: 12 months
Improvement of HbA1c
Measured: 12 months
Score on the Diabetes Quality Of Life
Measured: 12 months
MEMS cap data compared to PHQ-9 and AIS assessment
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2015 (estimated)
- Study startMar 2014
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (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
- 400 participants (estimated)
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
- Liebin Zhao, MSM, Study chair, Shanghai Clinical Centre for Endocrinology and Metabolism
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02330484
- Sponsor's protocol ID
- CCEMD-026
- Status last verified
- Dec 2014
- First submitted
- 24 Dec 2014
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Affect of Incentive Strategy on the Adherence to Medication Among Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02330484
- Acronym / sponsor ID
- CCEMD-026
- Conditions
- Type 2 Diabetes
- Keywords
- Community management， incentives, Medication Adherence
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Ruijin Hospital
- Study start
- Mar 2014
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 5 Jan 2015 (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.
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
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| incentives to physicians | Experimental | Behavioral: Give incentives to physician based on their patient's HbA1c improvementGive incentives to physicians according to patients' HbA1c improvement |
| incentives to patients | Experimental | Behavioral: Give incentives to patients based on their own HbA1c improvementGive incentives to patients according to their HbA1c improvement |
| incentives to both physicians and patients | Experimental | Behavioral: Give incentives to patients based on their own HbA1c improvement, Behavioral: Give incentives to physician based on their patient's HbA1c improvementintervention mode: Give incentives to physicians and patients according to patients' HbA1c improvement |
| Group with no incentives | No intervention | – |
Who may qualify
- Ages
- 40 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (7 listed)
- 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
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 patients based on their own HbA1c improvementGive incentives to patients based on their own HbA1c improvement | Behavioural | incentives to both physicians and patients, incentives to patients |
| Give incentives to physician based on their patient's HbA1c improvementGive incentives to physician based on their patient's HbA1c improvement | Behavioural | incentives to both physicians and patients, incentives to physicians |
Primary outcome
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data
Time frame: 12 months
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.
4 secondary outcomes
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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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.
Liebin Zhao, MSM study chair
Shanghai Clinical Centre for Endocrinology and Metabolism
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 patients based on their own HbA1c improvement and Give incentives to physician based on their patient's 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 8 inclusion and 7 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 5 Jan 2015. 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?
Hypoglycemic Medication adherence rates using electronically monitored adherence (MEMS cap) data (time frame: 12 months). 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 5 Jan 2015.