ClinicalTrials.gg
Sign In
CompletedNCT00358033Updated Apr 16, 2014

Strategies to Maintain Cardiac Risk Control After Discharge From Cardiovascular Risk Reduction Clinic

A Phase 3 interventional study of Counseling and Interactive Education in Diabetes, Dyslipidemia and Hypertension, sponsored by Providence VA Medical Center. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-04-16.

Sponsored by Providence VA Medical Center · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The purpose of this study is to determine whether a combined behavioral and pharmacological intervention provided by a multidisciplinary team will further reduce LDL-C, smoking, BP and Hb-A1C in diabetic patients with A1c between 7% and 9% when compared to usual care.

02

Conditions studied

  • Diabetes
  • Dyslipidemia
  • Hypertension
  • Coronary Atherosclerosis
03

In context

Diabetes Mellitus

11,089 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.

This study's enrollment of 200 is above the median of 80 across 8,491 interventional studies indexed under Diabetes Mellitus.

Browse Diabetes Mellitus studies →

Lead sponsor

Providence VA Medical Center is the lead sponsor of 14 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Previous enrollment in Cardiovascular Risk Reduction Clinic (CRRC)

  • Eligible for CRRC discharge:

    1. For DM patients:

      • HbA1c \< 7.0 %,
      • BP \< 130/85 mm Hg , and
      • LDL \< 100 mg/dl;

    2. For Non-DM patients:

      • BP \< 140/90 mm Hg, and
      • LDL \< 100 mg/dl;
  • Able and willing to sign informed consent.

Exclusion criteria

Exclusion Criteria:

  • Presence of conditions that might limit long-term compliance (eg, dementia, acute psychiatric decompensation within the previous 6 months, unstable psychiatric disorder);
  • Metastatic disease or terminal illness
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
200 participants (actual)

Study arms

  • Experimental
    group intervention

    pharmacist-led group intervention in behavioral and pharmacologic therapy

    Behavioral: Counseling · Behavioral: Interactive Education · Behavioral: Group Support · Procedure: Pharmacologic case management

  • Active comparator
    individual

    pharmacist-based individual clinic visits with behavioral and pharmacologic intervention for cardiac risk reduction

    Behavioral: Counseling · Procedure: Pharmacologic case management

  • No intervention
    usual care

    usual care

Interventions

  • BehavioralCounseling
  • BehavioralInteractive Education
  • BehavioralGroup Support
  • ProcedurePharmacologic case management

    Provided by clinical pharmacists

06

What researchers measure

Primary outcomes

  1. The number of patients who had non-compliance to ADA target goals in smoking, LDL cholesterol, blood pressure or Hb A1c.

    Time frame: 12 months

07

Study locations

1 site
  • Providence VAMC
    Providence, Rhode Island 02908, United States
08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jul 2003, a primary completion of May 2008 and a completion of May 2008. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 24, 2006
First posted
Jul 28, 2006
Start
Jul 2003
Primary completionActual
May 2008
CompletionActual
May 2008
Last update
Apr 16, 2014
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Apr 16, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00358033
Lead sponsor
Providence VA Medical Center
Collaborators
Merck Sharp & Dohme LLC
Responsible party
Wen-Chih Wu (Staff Cardiologist, Providence VA Medical Center) — Principal investigator
First posted
Jul 28, 2006
Start date
Jul 2003
Primary completion
May 2008
Completion
May 2008
Last update
Apr 16, 2014

Study contacts

Wen-Chih Wu, MD
principal investigator · Providence VAMC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2014. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Diabetes Mellitus →

Other studies from this sponsor

Providence VA Medical Center

Start the discussion