NCT00965510

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable type-2-diabetes

Timeline
Completed

Started Sep 2009

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
7 days until next milestone

Study Start

First participant enrolled

September 1, 2009

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

September 30, 2011

Status Verified

September 1, 2010

Enrollment Period

2 years

First QC Date

August 24, 2009

Last Update Submit

September 29, 2011

Conditions

Type 2 Diabetes

Keywords

diabetes

Outcome Measures

Primary Outcomes (1)

  • Scores on PHQ9, PAM and health indicators

    1 year

Secondary Outcomes (1)

  • Satisfaction with care coordination model.

    1 year

Study Arms (2)

Care Coordination

EXPERIMENTAL

Patients receive care coordination to improve their diabetes.

Behavioral: care coordination

control

NO INTERVENTION

patients with type II diabetes receive usual health care

Interventions

care coordinationBEHAVIORAL

patients receive care coordination to improve their type II diabetes

Care Coordination

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diabetes type II

You may not qualify if:

  • Non-English speaking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exeter Family Care

Exeter, New Hampshire, 03833, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gwendolyn Gladstone, MD

    SeaCare Health Services

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 24, 2009

First Posted

August 25, 2009

Study Start

September 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

September 30, 2011

Record last verified: 2010-09

Locations

US(1)