NCT00321269

Brief Summary

Patients with a diagnosis of CHF, NYHA class II, III or IV will be recruited for a study comparing a nursing intervention addressing CHF (SIM group) or CHF and depression (CIM group). Participants in the standard illness management program will receive an 8-week, 8-session intervention designed to help them improve daily weighing, salt-restriction, medication management, etc. This intervention will be conducted in a combination of home visits and phone visits. They will also receive interactive, telephone-based daily monitoring that assesses daily weight, dyspnea, fatigue and medication compliance. Patients in the comorbid illness management program will receive the same illness management program PLUS education and behavioral techniques designed to help them cope emotionally with the illness. The comorbid illness management home monitoring will include a twice-monthly screen for depression. Major Variables: The major outcomes will be depressive symptoms, health-related quality of life, functional status, heart failure symptom severity, and self-care behaviors in heart failure.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
134

participants targeted

Target at P50-P75 for not_applicable heart-failure

Timeline
Completed

Started Oct 2007

Typical duration for not_applicable heart-failure

Geographic Reach
1 country

2 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

May 1, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 3, 2006

Completed
1.4 years until next milestone

Study Start

First participant enrolled

October 1, 2007

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

October 21, 2015

Completed
Last Updated

December 24, 2015

Status Verified

November 1, 2015

Enrollment Period

3 years

First QC Date

May 1, 2006

Results QC Date

November 12, 2014

Last Update Submit

November 23, 2015

Conditions

Heart FailureDepression

Keywords

Home MonitoringHeart FailureDepression

Outcome Measures

Primary Outcomes (1)

  • Beck Depression Inventory II

    Depressive Symptoms measured on a Beck Depression Inventory Revised Possible Range 0 to 63. Higher scores indicate greater depression. Effectiveness of treatment indicated by a decline in the BDI-II score.

    Depression and psychological health will be assessed at week 1, week 8

Secondary Outcomes (1)

  • Health-Related Quality of Life

    Measured at week 1, week 8

Study Arms (2)

Single Illness Managment

ACTIVE COMPARATOR

This intervention includes standard disease self-management coaching for heart failure and helps patients set goals for fluid management, restricted salt-intake, and medication adherence.

Behavioral: Single Illness Management

Comorbid Illness Management

EXPERIMENTAL

This intervention includes the same self-management coaching found in the comparator arm, but also includes discussion of ways to cope and manage mood.

Behavioral: Comorbid Illness Management

Interventions

Single Illness ManagementBEHAVIORAL

8 week nursing intervention addressing Congestive Heart Failure

Single Illness Managment
Comorbid Illness ManagementBEHAVIORAL

8 week nursing intervention to address Congestive Heart Failure and emotional coping

Comorbid Illness Management

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Receiving treatment for NYHA Class 2-4 heart failure.
  • Patients of the Iowa City, IA or Columbia, MO Veterans Affairs Medical Center Primary Care or Cardiac Care Clinics.
  • Life expectancy greater than 6 months.
  • Must speak English.
  • Must possess a working telephone.

You may not qualify if:

  • Presence of major psychiatric illness such as schizophrenia, bipolar disorder and substance abuse (PTSD patients are eligible).
  • Life expectancy less than 3 months.
  • Planned relocation to a nursing home.
  • Marked visual or hearing impairment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Iowa City VA Medical Center

Iowa City, Iowa, 52246, United States

Location

Harry S. Truman Memorial VA Medical Center

Columbia, Missouri, 65201-5297, United States

Location

Related Publications (1)

  • Turvey C, Sheeran T, Dindo L, Wakefield B, Klein D. Validity of the Patient Health Questionnaire, PHQ-9, administered through interactive-voice-response technology. J Telemed Telecare. 2012 Sep;18(6):348-51. doi: 10.1258/jtt.2012.120220. Epub 2012 Aug 29.

    PMID: 22933480RESULT

MeSH Terms

Conditions

Heart FailureDepression

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBehavioral SymptomsBehavior

Results Point of Contact

Title
Carolyn Turvey
Organization
Iowa City VA Health Care System
Carolyn-Turvey@uiowa.edu
319 338 0581

Study Officials

  • Carolyn L Turvey, PhD MS

    VA Medical Center, Iowa City

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 1, 2006

First Posted

May 3, 2006

Study Start

October 1, 2007

Primary Completion

October 1, 2010

Study Completion

December 1, 2010

Last Updated

December 24, 2015

Results First Posted

October 21, 2015

Record last verified: 2015-11

Locations

US(2)