Physician Led Counseling in Management of Depression in T... | NCT02185482

Studies
Physician Led Counseling in Management of Depression in Type 2 Diabetes Mellitus

NCT02185482

Sponsor

Adwin Life Care

Status

Completed

Last Update Posted

Feb 5, 2016Estimated

Enrollment

150Actual

Phase

Not Applicable

Conditions

Depression
Type 2 Diabetes Mellitus

Interventions

Physician Supported Care
Usual care

Countries

India

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2016

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2014

Primary Completion Date

Sep 2015Actual

Completion Date

Nov 2015Actual

First Submitted Date

Jul 4, 2014

First Submission Date that Met QC Criteria

Jul 4, 2014

First Posted Date

Jul 9, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 4, 2016

Last Update Posted Date

Feb 5, 2016Estimated

Name	Class
NMP Medical Research Institute	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

150Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Physician Supported Care	Experimental	The intervention is an individualized, stepped-care depression treatment program provided by a depression clinical specialist primary care physician.	Behavioral: Physician Supported Care
Usual care	Other	Usual 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.	Other: Usual care

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Physician Supported Care	Behavioral		Physician Supported Care
Usual care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
change in depression using SCL-90 depression scale		Change from baseline to six month

Secondary Outcomes

Measure	Description	Time Frame
Glycemic control measured using glycosylated hemoglobin levels		Change from baseline to six month

Other Outcomes

Measure	Description	Time Frame
Global assessment of improvement using Patient Global Impression		Change from baseline to six months

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Eligible patients are ambulatory,
Had adequate hearing to complete a telephone interview,
Diabetic patients screened for depression

Exclusion Criteria:

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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

35 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ram Sharma, MD	NMP Medical Research Institute	Study Director
Naresh C Kumar, MD	Kaithal Civil Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
NMP Medical Research Institute		Kaithal	Haryana		India
GyanSanjeevani

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D003924	Diabetes Mellitus, Type 2
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided