NCT01339520

Brief Summary

The purpose of this study is to see if the use of a diabetic scorecard during clinic visits can improve glycemic control, blood pressure control, LDL-cholesterol, aspirin usage, and amount of exercise in adults over age 40 with uncontrolled Type II diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable type-2-diabetes

Timeline
Completed

Started Nov 2008

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

November 1, 2008

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

April 19, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 20, 2011

Completed
Last Updated

August 11, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

April 19, 2011

Last Update Submit

August 10, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Change in total score

    The total score was calculated by points assigned to variables (systolic blood pressure, diastolic blood pressure, HbA1c, aspirin usage and daily exercise). The maximal score of 100 corresponds to all variables at target. Fewer points were assigned to higher blood pressure, worse HbA1c levels, less exercise, etc.

    9 months

Secondary Outcomes (2)

  • LDL-cholesterol

    9 months

  • HbA1c

    9 months

Study Arms (2)

Scorecard

EXPERIMENTAL

Score of points for variables.

Behavioral: ScorecardBehavioral: Control

Control

NO INTERVENTION

Standard of care for diabetes subjects

Interventions

ScorecardBEHAVIORAL

Points were assigned for blood pressure, HbA1c level, LDL-cholesterol level, aspirin use and exercise level.

Scorecard
ControlBEHAVIORAL

Standard of care for diabetes subjects

Scorecard

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Uncontrolled Type II diabetes (HbA1c ≥ 8%)

You may not qualify if:

  • Type I Diabetes
  • HbA1c \< 8%
  • Inability to understand the diabetes scorecard due to condition (i.e. dementia, mental retardation, etc) or language barrier
  • Pregnancy
  • Planning to move within the next year

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical Faculty Associates, George Washington University

Washington D.C., District of Columbia, 20037, United States

Location

Related Publications (1)

  • Irwig MS, Sood P, Ni D, Amass T, Khurana PS, Jayanthi VV, Wang L, Adler SM. A diabetes scorecard does not improve HbA(1c), blood pressure, lipids, aspirin usage, exercise and diabetes knowledge over 9 months: a randomized controlled trial. Diabet Med. 2012 Sep;29(9):1206-12. doi: 10.1111/j.1464-5491.2012.03610.x.

    PMID: 22332914DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician

Study Record Dates

First Submitted

April 19, 2011

First Posted

April 20, 2011

Study Start

November 1, 2008

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 11, 2017

Record last verified: 2017-08

Locations

US(1)