NCT02330484

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
400

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Mar 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2014

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

December 24, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
Last Updated

January 5, 2015

Status Verified

December 1, 2014

Enrollment Period

1.3 years

First QC Date

December 24, 2014

Last Update Submit

December 31, 2014

Conditions

Type 2 Diabetes

Keywords

Community management， incentives, Medication Adherence

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (4)

  • Self-report medication adherence

    12 months

  • Improvement of HbA1c

    12 months

  • Score on the Diabetes Quality Of Life

    12 months

  • MEMS cap data compared to PHQ-9 and AIS assessment

    12 months

Study Arms (4)

incentives to physicians

EXPERIMENTAL

Give incentives to physicians according to patients' HbA1c improvement

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

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

Behavioral: Give incentives to patients based on their own HbA1c improvementBehavioral: Give incentives to physician based on their patient's HbA1c improvement

Group with no incentives

NO INTERVENTION

Interventions

Give incentives to patients based on their own HbA1c improvementBEHAVIORAL

Give incentives to patients based on their own HbA1c improvement

incentives to both physicians and patientsincentives to patients
Give incentives to physician based on their patient's HbA1c improvementBEHAVIORAL

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

incentives to both physicians and patientsincentives to physicians

Eligibility Criteria

Age40 Years - 74 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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
  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital, Shanghai Jiao-Tong University School of Medicine

Shanghai, Shanghai Municipality, 200025, China

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Medication Adherence

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient CompliancePatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Liebin Zhao, MSM

    Shanghai Clinical Centre for Endocrinology and Metabolism

    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

December 24, 2014

First Posted

January 5, 2015

Study Start

March 1, 2014

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

January 5, 2015

Record last verified: 2014-12

Locations

CN(1)