Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus
Physician Led Counseling for Depression in Type 2 Diabetes Mellitus: A Randomized, Controlled Trial
1 other identifier
interventional
150
1 country
2
Brief Summary
There is a high prevalence of depression in patients with diabetes mellitus. Depression has been shown to be associated with poor self-management (adherence to diet, exercise, checking blood glucose levels) levels in patients with diabetes.To determine whether enhancing quality physician's care for depression improves both depression and diabetes outcomes in patients with depression and diabetes.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable depression
Started Aug 2014
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 4, 2014
CompletedFirst Posted
Study publicly available on registry
July 9, 2014
CompletedStudy Start
First participant enrolled
August 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2015
CompletedFebruary 5, 2016
January 1, 2016
1.1 years
July 4, 2014
February 4, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change in depression using SCL-90 depression scale
Change from baseline to six month
Secondary Outcomes (1)
Glycemic control measured using glycosylated hemoglobin levels
Change from baseline to six month
Other Outcomes (1)
Global assessment of improvement using Patient Global Impression
Change from baseline to six months
Study Arms (2)
Physician Supported Care
EXPERIMENTALThe intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.
Usual care
OTHERUsual care patients will be advised to consult with their primary care physician regarding depression. Primary care physicians prescribe antidepressant medication and can refer patients to the Mental Health Services.
Interventions
Eligibility Criteria
You may qualify if:
- Eligible patients are ambulatory,
- Had adequate hearing to complete a telephone interview,
- Diabetic patients screened for depression
You may not qualify if:
- Currently in care with a psychiatrist;
- Diagnosis of bipolar disorder or schizophrenia;
- Use of antipsychotic or mood stabilizer medication
- Mental confusion on interview, suggesting significant dementia.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Adwin Life Carelead
- NMP Medical Research Institutecollaborator
Study Sites (2)
NMP Medical Research Institute
Kaithal, Haryana, India
GyanSanjeevani
Jaipur, Rajasthan, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Ram Sharma, MD
NMP Medical Research Institute
- PRINCIPAL INVESTIGATOR
Naresh C Kumar, MD
Kaithal Civil Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 4, 2014
First Posted
July 9, 2014
Study Start
August 1, 2014
Primary Completion
September 1, 2015
Study Completion
November 1, 2015
Last Updated
February 5, 2016
Record last verified: 2016-01