NCT00461513

Brief Summary

The purpose of this study is to evaluate a patient-centered disease management intervention for VA patients with heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
384

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2009

Typical duration for all trials

Geographic Reach
1 country

4 active sites

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

First Submitted

Initial submission to the registry

April 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 18, 2007

Completed
2 years until next milestone

Study Start

First participant enrolled

May 1, 2009

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

December 8, 2014

Completed
Last Updated

July 12, 2018

Status Verified

June 1, 2018

Enrollment Period

3.1 years

First QC Date

April 17, 2007

Results QC Date

November 19, 2014

Last Update Submit

June 14, 2018

Conditions

Heart Failure, Congestive

Keywords

Heart Failure, CongestiveDisease ManagementHealth StatusQuality of LifeTelemedicineDepression

Outcome Measures

Primary Outcomes (1)

  • Change in Chronic Heart Failure Health Status Between Baseline and 12 Months.

    The primary outcome was average change in the Kansas City Cardiomyopathy Questionnaire Overall Summary Score. This is reported for each group (Intervention and Usual Care). The average for each group and standard deviation are reported. A positive score change represents an improvement in overall patient health status for the group of patients with congestive heart failure. A negative score change represents a worsening in overall patient health status for the group of patients with congestive heart failure.

    12 months

Secondary Outcomes (2)

  • Mortality at 1 Year

    12 months

  • Hospitalization at 1 Year

    12 months

Study Arms (2)

Intervention

The PCDM intervention will include evaluation of CHF care by the collaborative care team, with diagnostic and therapeutic treatment recommendations based on current ACC/AHA national clinical practice guidelines, daily telemonitoring and patient self-care support utilizing the VA telemonitoring system, and screening and treatment for comorbid depression. The Collaborative Care (CC) team at each site will consist of a primary care provider, cardiologist, and psychiatrist, who are local opinion leaders, as well as a nurse site coordinator and pharmacist. For a given intervention patient, there will be an initial assessment of care by the CC team following the enrollment visit. Each intervention patient will be re-reviewed by the CC team a minimum of 2 additional times (at 6-weeks and 6 months). In addition, patients will have daily telemonitoring, and their care will be reviewed by the CC team if the telemonitoring data suggests clinical deterioration.

Behavioral: Intervention

Usual Care

Patients randomized to the usual care arm will continue to receive care at the discretion of their regular VA providers (for a given patient, this could include cardiology specialty care in addition to PCP care, participation in site-specific CHF programs such as CHF patient education classes, etc.), in direct continuity with the care they were receiving prior to enrollment. Patients in the usual care group will also be given information sheets that outline self-care for CHF, and will be provided with a scale, if needed, at the enrollment visit. Patients in the usual care group will have the same amount of interaction with the study team as the intervention patients (i.e. complete questionnaires at the same frequency; have the same study visits). PCPs of usual care patients will be notified of the results of all screening studies (patient survey results, lab tests) as we have done in previous studies.

Interventions

InterventionBEHAVIORAL

Disease management has emerged as a promising strategy to improve the outcomes of patients with CHF. Disease management in this study will use a multidisciplinary collaborative care, leveraging health information technology, and focusing on patient self-care.Collaborative care is the use of multidisciplinary teams to deliver evidence-based treatment to a defined population of patients with chronic illness.

Intervention

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

VA Patients in Denver, Palo Alto, Richmond and Seattle who have a diagnosis of Chronic Heart Failure and have low health status.

You may qualify if:

  • Diagnosis of Chronic Heart Failure;
  • low health status.

You may not qualify if:

  • Cognitive/psychiatric impairment (inability to complete questionnaires);
  • nursing home resident;
  • irreversible non-cardiac medical condition likely to affect 6-month survival or ability to execute study protocol;
  • prior heart transplantation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Eastern Colorado Health Care System, Denver, CO

Denver, Colorado, 80220, United States

Location

Hunter Holmes McGuire VA Medical Center, Richmond, VA

Richmond, Virginia, 23249, United States

Location

VA Puget Sound Health Care System Seattle Division, Seattle, WA

Seattle, Washington, 98108, United States

Location

Related Publications (3)

  • Bekelman DB, Plomondon ME, Sullivan MD, Nelson K, Hattler B, McBryde C, Lehmann KG, Potfay J, Heidenreich P, Rumsfeld JS. Patient-centered disease management (PCDM) for heart failure: study protocol for a randomised controlled trial. BMC Cardiovasc Disord. 2013 Jul 9;13:49. doi: 10.1186/1471-2261-13-49.

    PMID: 23837415BACKGROUND

  • Lum HD, Carey EP, Fairclough D, Plomondon ME, Hutt E, Rumsfeld JS, Bekelman DB. Burdensome Physical and Depressive Symptoms Predict Heart Failure-Specific Health Status Over One Year. J Pain Symptom Manage. 2016 Jun;51(6):963-70. doi: 10.1016/j.jpainsymman.2015.12.328. Epub 2016 Feb 26.

    PMID: 26921492DERIVED

  • Bekelman DB, Plomondon ME, Carey EP, Sullivan MD, Nelson KM, Hattler B, McBryde CF, Lehmann KG, Gianola K, Heidenreich PA, Rumsfeld JS. Primary Results of the Patient-Centered Disease Management (PCDM) for Heart Failure Study: A Randomized Clinical Trial. JAMA Intern Med. 2015 May;175(5):725-32. doi: 10.1001/jamainternmed.2015.0315.

    PMID: 25822284DERIVED

MeSH Terms

Conditions

Heart FailureDepression

Interventions

Methods

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Results Point of Contact

Title
Dr. Meg Plomondon
Organization
Veterans Health Administration
Meg.Plomondon@va.gov
303-370-75770

Study Officials

  • John Spalding Rumsfeld, MD PhD

    VA Eastern Colorado Health Care System, Denver, CO

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 17, 2007

First Posted

April 18, 2007

Study Start

May 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

July 12, 2018

Results First Posted

December 8, 2014

Record last verified: 2018-06

Locations

US(4)