Compare Diabetes Distress and DepressionNCT01755351
Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients
An observational study of Compare Diabetes Distress and Depression, run by Shandong Provincial Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Compare Diabetes Distress and Depression
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Dec 2011to Dec 2012
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly,
Who cannot join
- patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Compare Diabetes Distress and Depression
- Medical subject headings
- Depression
What is being measured
The primary outcome is the main question the study is designed to answer.
The influence of diabetes distress on treatment sdherence
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Diabetes Distress and DepressionStudies of the same condition, open and under way.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Shandong Provincial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, cuiping-xu, Shandong Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01755351
- Sponsor's protocol ID
- ShandongPH
- Status last verified
- Jan 2013
- First submitted
- 18 Dec 2012
- Last updated
- 3 Jan 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study About the Influence of Diabetes Diatress and Depression on Treatment Adherence in Chinese Type 2 Diabetes Patients
- ClinicalTrials.gov ID
- NCT01755351
- Acronym / sponsor ID
- ShandongPH
- Conditions
- Compare Diabetes Distress and Depression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Shandong Provincial HospitalOther government
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- First posted
- 24 Dec 2012 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 1)aged between 18-80 years, 2)diagnosed with diabetes for at least 6 month, 3) having the ability to communicate fluently and clearly,
Key exclusion criteria (1 listed)
- patients who had the diagnosis of dementia or psychosis and severe diabetes complications (e.g., on dialysis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The influence of diabetes distress on treatment sdherence
Time frame: 6 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2013.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Compare Diabetes Distress and Depression, run by Shandong Provincial Hospital 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 1 inclusion and 1 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: finished, as of the sponsor's last update on 3 Jan 2013. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The influence of diabetes distress on treatment sdherence (time frame: 6 month). 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 3 Jan 2013.