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Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients

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ClinicalTrials.gov Identifier: NCT01755351
Recruitment Status : Completed
First Posted : December 24, 2012
Last Update Posted : January 3, 2013
Sponsor:
Information provided by (Responsible Party):
cuiping-xu, Shandong Provincial Hospital

Tracking Information
First Submitted Date December 18, 2012
First Posted Date December 24, 2012
Last Update Posted Date January 3, 2013
Study Start Date December 2011
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: December 21, 2012)
The influence of diabetes distress on treatment sdherence [ Time Frame: 6 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients
Official Title Not Provided
Brief Summary

An effective treatment adherence was a key to make the treatment success, some reports had shown that psychologicl factors impact patients adherence seriously,however, in China, the researches were only limited to depression and diabetes,diabetes distress was neglected. Some western studies had demonstrated the impact of diabetes distress on diabetes. Thus, we hypothesized that: 1.perhaps our present depression-oriented health education was inadequate to promote patients' adherence, diabetes distress might played a more important part than depression in patients' treatment adherence. 2. there might be a high prevalence of diabetes distress in Chinese type 2 diabetes; so, the comparative study between diabetes distress and depresion was conducted.

Objectives: to explore the relationship of diabetes-related distress and depression,and to compare the influence of diabetes distress and depression on treatment adherence in Chinese type 2 diabetes .

Research design and method:we surveyed 200 type 2 diabetic patients from 2 third-class hospitals using the Diabetes Distress Scale, Zung Self-rating Depression Scale, and Revised Treatment Adherence in Diabetes Questionnaire (RADQ)simultaneously.

Detailed Description Not Provided
Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration 1 Year
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population patients with type 2 diabetes who visited the two local hospitals between December 2011 and April 2012, were invited to participate in this cross-sectional survey study.
Condition Compare Diabetes Distress and Depression
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: December 21, 2012)
200
Original Actual Enrollment Same as current
Study Completion Date Not Provided
Actual Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly,

Exclusion Criteria:

  • patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT01755351
Other Study ID Numbers ShandongPH
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party cuiping-xu, Shandong Provincial Hospital
Study Sponsor Shandong Provincial Hospital
Collaborators Not Provided
Investigators Not Provided
PRS Account Shandong Provincial Hospital
Verification Date January 2013