NCT00223340

Brief Summary

The purpose of this pilot study is to collect preliminary information about the best way to implement an intervention to reduce the risks of heart disease and stroke.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable diabetes

Timeline
Completed

Started Mar 2005

Typical duration for not_applicable diabetes

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

March 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 22, 2005

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2007

Completed
Last Updated

July 2, 2012

Status Verified

June 1, 2012

Enrollment Period

2.3 years

First QC Date

September 13, 2005

Last Update Submit

June 28, 2012

Conditions

Diabetes

Keywords

patient activationprimary carediabetescardiovascular risk

Outcome Measures

Primary Outcomes (1)

  • Document changes made to study procedures to better implement this study's interventions that are designed to reduce risks of heart disease and stroke

Secondary Outcomes (4)

  • Patient Outcome Measures: Hemoglobin A1c (HbA1c), lipids (low-density lipoprotein [LDL] non-high-density lipoprotein [HDL] triglycerides), blood pressure

  • Patient assessed health status, diabetes self-care activities and knowledge of cardiovascular (CV) risk factors

  • Physician Outcome Measures: Physician knowledge, attitude and readiness to change practice; Physician-level measure of patient-centeredness of encounter and interpersonal communication

  • Assessment of Chronic Illness Care (ACIC) Surveys

Interventions

Patient Activation and Diabetes RegistryBEHAVIORAL

Eligibility Criteria

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

You may qualify if:

  • Patient must be diagnosed with diabetes for at least 12 months.
  • Patient must be with current physician for at least 12 months.
  • Study staff must be able to reach patient by telephone.

You may not qualify if:

  • Pregnant women are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Texas Health Science Center at San Antonio (Texas)

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Diabetes MellitusPatient Participation

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Michael L Parchman, MD, MPH

    Univ. of Texas Health Science Center at San Antonio

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 22, 2005

Study Start

March 1, 2005

Primary Completion

June 1, 2007

Study Completion

June 1, 2007

Last Updated

July 2, 2012

Record last verified: 2012-06

Locations

US(1)