SeaCare's Care Coordination for Diabetes Management in a Primary Care Office

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00965510
Recruitment Status : Terminated (insufficient recruitment of control and study patients)
First Posted : August 25, 2009
Last Update Posted : September 30, 2011
New Hampshire Charitable Foundation
Information provided by:
SeaCare Health Services

Brief Summary:

The purpose of this study is to determine whether it is possible to improve health outcomes for patients with Type II diabetes, a community-based health care agency will offer care coordination to half of a study group in a family practice office. The intervention will include assessing patients' status using two instruments:

a depression screen (the PHQ9) and a motivation to change scale (the Patient Activation Measure, PAM). A masters-level social worker will counsel patients in the intervention group. Changes in patients' health status, PHQ9 scores and PAM scores over one year will be measured. Outcomes will be compared between the study group and the group without intervention.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Behavioral: care coordination Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management
Study Start Date : September 2009
Actual Primary Completion Date : September 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Care Coordination
Patients receive care coordination to improve their diabetes.
Behavioral: care coordination
patients receive care coordination to improve their type II diabetes

No Intervention: control
patients with type II diabetes receive usual health care

Primary Outcome Measures :
  1. Scores on PHQ9, PAM and health indicators [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Satisfaction with care coordination model. [ Time Frame: 1 year ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diabetes type II

Exclusion Criteria:

  • Non-English speaking

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00965510

United States, New Hampshire
Exeter Family Care
Exeter, New Hampshire, United States, 03833
Sponsors and Collaborators
SeaCare Health Services
New Hampshire Charitable Foundation
Principal Investigator: Gwendolyn Gladstone, MD SeaCare Health Services

Responsible Party: Gwendolyn Gladstone, MD, SeaCare Health Services Identifier: NCT00965510     History of Changes
Other Study ID Numbers: 9118277Downing306
First Posted: August 25, 2009    Key Record Dates
Last Update Posted: September 30, 2011
Last Verified: September 2010

Keywords provided by SeaCare Health Services:

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases