Trial Outcomes & Findings for Integrating Depression Services Into DM Management (NCT NCT01098253)

Results Overview

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

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

182 participants

Primary outcome timeframe

3 months

Results posted on

2012-03-09

Participant Flow

Patients were recruited from three primary care practices in Philadelphia, Pennsylvania. The protocol was approved by the University of Pennsylvania Institutional Review Board. From April 2010 to April 2011, patients were identified and enrolled.

This trial consisted of two phases: the run-in phase and the randomized controlled trial phase. The purpose of the 2-week run-in phase was to collect pre-intervention adherence rates for all patients.

Participant milestones

Participant milestones
Measure	Integrated Care Intervention We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.	Usual Care
Overall Study STARTED	94	88
Overall Study COMPLETED	92	88
Overall Study NOT COMPLETED	2	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Integrating Depression Services Into DM Management

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Integrated Care Intervention n=94 Participants We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.	Usual Care n=88 Participants	Total n=182 Participants Total of all reporting groups
Age Continuous	57.8 Years STANDARD_DEVIATION 9.4 • n=5 Participants	57.1 Years STANDARD_DEVIATION 9.6 • n=7 Participants	57.4 Years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	64 Participants n=5 Participants	58 Participants n=7 Participants	122 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Region of Enrollment United States	94 participants n=5 Participants	88 participants n=7 Participants	182 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 months

Population: Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).

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

Outcome measures

Outcome measures
Measure	Integrated Care Intervention n=92 Participants We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.	Usual Care n=88 Participants
Hemoglobin A1C	60.9 Percentage of participants with HbA1c <7 1.8	35.7 Percentage of participants with HbA1c <7 1.9

SECONDARY outcome

Timeframe: 3 months

Population: Analysis proceeded at the patient level and patients were analyzed according to the treatment to which they were randomized (intent-to-treat).

Depressive symptoms were measured using the nine-item Patient Health Questionnaire (PHQ-9). PHQ-9 scored on a range from 0 to 27, where lower scores represent fewer depressive symptoms.

Outcome measures

Outcome measures
Measure	Integrated Care Intervention n=92 Participants We carried out an integrated care intervention in which the integrated care manager collaborated with physicians to offer education to patients, guideline-based treatment recommendations, and to monitor adherence and clinical status.	Usual Care n=88 Participants
Nine Item Patient Health Questionnaire (PHQ-9)	58.7 Percentage of participants with PHQ-9 <5	30.7 Percentage of participants with PHQ-9 <5

Adverse Events

Integrated Care Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Usual Care

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Hillary R Bogner

University of Pennsylvania, Perelman School of Medicine

Phone: 215-746-4181

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place