NCT00481286

Brief Summary

The purpose of this study is to determine if group clinics help older veterans change behaviors with the goal of improving diabetes outcomes.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
129

participants targeted

Target at P50-P75 for not_applicable diabetes

Timeline
Completed

Started Apr 2007

Typical duration for not_applicable diabetes

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

April 1, 2007

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

May 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 1, 2007

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

March 2, 2020

Status Verified

October 1, 2009

Enrollment Period

1 year

First QC Date

May 31, 2007

Last Update Submit

February 27, 2020

Conditions

DiabetesHypertension

Keywords

Group clinicsGoal settingDiabetesHypertensionAge 50+

Outcome Measures

Primary Outcomes (1)

  • Change in systolic blood pressure; change in Hemoglobin A1C; change in low density lipoprotein

    Change in systolic blood pressure; change in Hemoglobin A1C; change in low

    12 months

Secondary Outcomes (1)

  • Attainment of benchmark levels for SBP, A1C, LDL; self-management performance (self-report); completion of group clinic

    12 months

Study Arms (2)

Group Clinic

EXPERIMENTAL

Patients in Group Clinic arm will meet every 3rd week for 12 weeks, for a total of 4 visits. At each visit, BP will be measured, home BP and glucose measurements collected. Each visit will include group-based education and feedback sessions, with an individualized process of selecting and modifying process of care goals for systolic BP, H1C, and LDL cholesterol. Short-term health behavior change goals will also be discussed.

Behavioral: Improving outcomes using group clinics for older patients

Uusual Care

PLACEBO COMPARATOR

Older diabetes patients will attend regular clinician visits and one targeted primary care physician visit during the 12 weeks post-enrollment. They will be enrolled in a diabetes education class. Blood pressure, H1C and lipids will be measured at enrollment, 6 weeks , and 12 weeks.

Behavioral: Standard of Care

Interventions

Improving outcomes using group clinics for older patientsBEHAVIORAL

Collaborative group clinics to empower older patients to adopt goal-setting behaviors with their health care providers and improve their diabetes-related outcomes.

Also known as: Diabetes Group Clinic, Goal-setting Clinic
Group Clinic
Standard of CareBEHAVIORAL

Standard of care for diabetes patients

Also known as: Diabetes usual care
Uusual Care

Eligibility Criteria

Age50 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosis of diabetes and hypertension
  • HgA1C value greater than or equal to 7.5
  • Creatinine value less than or equal to 2.0mg/dl
  • SBP greater than or equal to 140

You may not qualify if:

  • Prior diagnoses of dementia using ICD-9 codes validated for a VA population

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Teal CR, Haidet P, Balasubramanyam AS, Rodriguez E, Naik AD. Measuring the quality of patients' goals and action plans: development and validation of a novel tool. BMC Med Inform Decis Mak. 2012 Dec 27;12:152. doi: 10.1186/1472-6947-12-152.

    PMID: 23270422DERIVED

  • Naik AD, Palmer N, Petersen NJ, Street RL Jr, Rao R, Suarez-Almazor M, Haidet P. Comparative effectiveness of goal setting in diabetes mellitus group clinics: randomized clinical trial. Arch Intern Med. 2011 Mar 14;171(5):453-9. doi: 10.1001/archinternmed.2011.70.

    PMID: 21403042DERIVED

MeSH Terms

Conditions

Diabetes MellitusHypertension

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Aanand D Naik, MD

    Baylor College of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Medicine-Health Srvcs Research

Study Record Dates

First Submitted

May 31, 2007

First Posted

June 1, 2007

Study Start

April 1, 2007

Primary Completion

April 1, 2008

Study Completion

September 1, 2009

Last Updated

March 2, 2020

Record last verified: 2009-10