NCT00700908

Brief Summary

Aim 1. Determine the impact of a daily, automated telephone intervention on HbA1c levels compared to standard care in older patients with type 2 diabetes. Aim 2. Determine the impact of the automated telephone intervention compared to standard care on adherence to prescribed SMBG frequency in older patients with type 2 diabetes. Aim 3. Determine the impact of the automated telephone intervention compared to standard care on self-reported diabetic control problems in older patients with type 2 diabetes. Aim 4. Determine the impact of the automated telephone intervention compared to standard care on self-reported attitudes and health beliefs concerning diabetes in older patients with type 2 diabetes

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

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

Timeline
Completed

Started Jun 2007

Shorter than P25 for not_applicable type-2-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

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2008

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
Last Updated

February 22, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

June 17, 2008

Last Update Submit

February 20, 2013

Conditions

Type 2 Diabetes

Keywords

type 2 diabetestelephone interventionautomated

Outcome Measures

Primary Outcomes (1)

  • Change in HbA1c

    three months

Secondary Outcomes (1)

  • Change in adherence to SMBG frequency

    three months

Study Arms (2)

1

EXPERIMENTAL

Automated telephone intervention

Behavioral: automated telephone intervention vs. usual care

2

ACTIVE COMPARATOR

Usual care

Behavioral: automated telephone intervention vs. usual care

Interventions

automated telephone intervention vs. usual careBEHAVIORAL
12

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age greater or equal to 55
  • Type 2 diabetes
  • English speaking
  • Ability to use glucose meter

You may not qualify if:

  • Unable to give informed consent
  • Unwilling to allow SMBG levels to be shard with primary care physician

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary Care Center University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Judith Graziano, PhD, RN

    University of Minnesota

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

June 1, 2008

Last Updated

February 22, 2013

Record last verified: 2013-02

Locations

US(1)