- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00965510
SeaCare's Care Coordination for Diabetes Management in a Primary Care Office
Improved Management of Type II Diabetes in a Primary Care Office With Targeted Case Management
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.
Study Overview
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
New Hampshire
-
Exeter, New Hampshire, United States, 03833
- Exeter Family Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Diabetes type II
Exclusion Criteria:
- Non-English speaking
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Care Coordination
Patients receive care coordination to improve their diabetes.
|
patients receive care coordination to improve their type II diabetes
|
No Intervention: control
patients with type II diabetes receive usual health care
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Scores on PHQ9, PAM and health indicators
Time Frame: 1 year
|
1 year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Satisfaction with care coordination model.
Time Frame: 1 year
|
1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Gwendolyn Gladstone, MD, SeaCare Health Services
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 9118277Downing306
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Type 2 Diabetes
-
Antonio Di MauroCompletedType-2 DiabetesItaly
-
University of Erlangen-Nürnberg Medical SchoolCompletedType 2-diabetesGermany
-
DiaMedica Therapeutics IncCompletedDiabetes Type 2Netherlands
-
RenJi HospitalUnknownType 2 Diabetes.China
-
Nanjing First Hospital, Nanjing Medical UniversityRecruitingType 2 Diabetes MellitusChina
-
Xiangya Hospital of Central South UniversityRecruitingType 2 Diabetes MellitusChina
-
Imperial College LondonAstraZeneca; Huma; North West London Collaboration of CCGs (NWL CCGs); Imperial...CompletedType 2 Diabetes MellitusUnited Kingdom
-
Universiti Sains MalaysiaCompleted
-
University of Alabama at BirminghamActive, not recruitingType 2 Diabetes MellitusUnited States
-
University of Alabama at BirminghamUnited States Department of Defense; Loma Linda University; Brenda Davis Nutrition... and other collaboratorsCompletedType 2 Diabetes Mellitus
Clinical Trials on care coordination
-
VA Office of Research and DevelopmentCompletedSmokingUnited States
-
Johns Hopkins UniversityNational Institute of Mental Health (NIMH); National Institute on Aging (NIA); Leonard & Helen R. Stulman Charitable Foundation and other collaboratorsCompleted
-
Arizona State UniversityNational Institute of Nursing Research (NINR); University of Wisconsin, MilwaukeeCompletedCognitive Impairment | Chronic IllnessUnited States
-
University Hospital, BordeauxCompletedCare Coordination in OncologyFrance
-
Mathematica Policy Research, Inc.Centers for Medicare and Medicaid ServicesUnknownCoronary Artery Disease | Diabetes | Cancer | Chronic Obstructive Pulmonary Disease | Major Depression | Alzheimer's Disease | Congestive Heart Failure | Cerebrovascular Disease | Psychotic DisorderUnited States
-
HealthPartners InstitutePatient-Centered Outcomes Research Institute; Minnesota Department of Health; MN Community MeasurementActive, not recruitingChronic Disease | Multi-morbidity | Care CoordinationUnited States
-
University of Wisconsin, MadisonRecruitingEmergency Department VisitUnited States
-
Duke UniversityCompleted
-
University of Texas Southwestern Medical CenterCompletedBreast Cancer | Colorectal CancerUnited States
-
University of Texas at AustinCompletedHIV | Substance Use | Care CoordinationUnited States