Integrating Depression Services Into DM Management

NCT01098253 | Completed Results DMC

• 1 other identifier: 1-09-CR-07
• Study Type: interventional
• Target: 182
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this proposal is to integrate depression services into improving adherence for oral hypoglycemic agents so that a single program can assist patients. The investigators hypothesized that patients in the intervention would demonstrate improved adherence to patients' oral hypoglycemic agents and antidepressants as well as improved clinical outcomes.

Conditions

Type 2 Diabetes Mellitus; Depression

Keywords

adherence; diabetes mellitus; depression; primary health care

Outcome Measures

Primary Outcomes (1)

• Hemoglobin A1C

  HbA1c levels will be obtained in accordance with ADA guidelines (1) employing the in2it A1C Analyzer. The Analyzer offers accurate point of care HbA1c testing. Point of care testing using this device has acceptable precision and agreement in comparison with laboratory services

  3 months

Secondary Outcomes (1)

• Nine Item Patient Health Questionnaire (PHQ-9)

  3 months

Study Arms (2)

Adherence Intervention

EXPERIMENTAL

Factors affecting adherence to oral hypoglycemic agents and antidepressants were addressed using a problem solving process.

Behavioral: Adherence Intervention

Usual Care

NO INTERVENTION

Interventions

Adherence Intervention BEHAVIORAL

Factors affecting adherence are addressed using a problem solving process.

Adherence Intervention

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years and older
• a current diagnosis of Type 2 DM
• current prescription for an oral hypoglycemic agent
• current prescription for an antidepressant
• able to communicate in English
• willing to give informed consent.

You may not qualify if:

• inability to give informed consent
• significant cognitive impairment at baseline (Mini-Mental State Examination (MMSE) \<21)
• residence in a care facility that provides medications
• unwillingness or inability to use the Medication Event Monitoring System

Sponsors & Collaborators

• University of Pennsylvania: lead
• American Diabetes Association: collaborator

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Depression; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Behavioral Symptoms; Behavior

Limitations and Caveats

Our primary care sites might not be representative of most primary care practices. Patients in the usual care group did not have the same number of in person contacts as those in the integrated care intervention to control for attention.

Results Point of Contact

• Title: Dr. Hillary R Bogner
• Organization: University of Pennsylvania, Perelman School of Medicine

hillary.bogner@uphs.upenn.edu

215-746-4181

Study Officials

• Hillary R. Bogner, MD

  University of Pennsylvania

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD MSCE/ Assistant Professor

Study Record Dates

• First Submitted: April 1, 2010
• First Posted: April 2, 2010
• Study Start: January 1, 2009
• Primary Completion: April 1, 2011
• Study Completion: April 1, 2011
• Last Updated: March 9, 2012
• Results First Posted: March 9, 2012

Record last verified: 2012-02

Locations

US (1)