NCT00555360

Brief Summary

Informal caregivers, assisted by health information technology may help to fill the gaps in VA care management of heart failure patients by enhancing support for patients' treatment adherence, behavior changes, and symptom monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
372

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

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

November 6, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 8, 2007

Completed
1.6 years until next milestone

Study Start

First participant enrolled

June 1, 2009

Completed
3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 15, 2015

Completed
Last Updated

September 15, 2015

Status Verified

August 1, 2015

Enrollment Period

3.6 years

First QC Date

November 6, 2007

Results QC Date

January 15, 2015

Last Update Submit

August 12, 2015

Conditions

Heart Failure, Congestive

Keywords

Health Information TechnologyPatient Care ManagementSelf CareQuality of LifeFamily or non-Family Informal Caregivers

Outcome Measures

Primary Outcomes (1)

  • Heart Failure-specific Quality of Life

    Measured by the Minnesota Living with Heart Failure Questionnaire (MLHFQ). Lower scores indicate better functioning. MLHFQ contains 21 items with answer choices ranging from 0 to 5. Overall scores on the instrument range from 0 to 105.

    twelve-month followup

Secondary Outcomes (2)

  • Revised Heart Failure Self-Care Behavior Scale (HFSCB)

    twelve-month follow-up

  • Adherent to Heart Failure Medication

    twelve-month follow-up

Study Arms (2)

Arm 1

EXPERIMENTAL

Veterans with heart failure that can identify an out-of-home informal caregiver

Behavioral: HITCM+CP

Arm 2

ACTIVE COMPARATOR

Veterans with heart failure that can identify an out-of-home informal caregiver

Behavioral: HITCM only

Interventions

HITCM+CPBEHAVIORAL

Weekly automated assessment calls with follow-up by a care manager and a CarePartner for 12 months. Baseline, 6-month and 12-month follow-up.

Arm 1
HITCM onlyBEHAVIORAL

Weekly automated assessment calls with follow-up by a care manager for 12 months. Baseline, 6-month and 12-month follow-up.

Arm 2

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans with heart failure (HF) treated at the VA Louis Stokes (Cleveland) facilities will be eligible if they have New York Heart Association (NYHA) Class II-III diastolic or systolic HF noted by inpatient or outpatient ICD-9 codes.

You may not qualify if:

  • Veterans treated at the VA Louis Stokes (Cleveland) facilities will be ineligible if they:
  • have a serious mental illness or cognitive dysfunction, e.g., psychosis, dementia, or active substance abuse (alcohol and/or other drugs);
  • do not speak English fluently;
  • are receiving palliative care due to advanced HF or other health problems;
  • receive the majority of their HF care from providers outside of the VA;
  • are unable to use a telephone to respond to weekly automated self-management support calls; or
  • are unable to nominate an eligible informal caregiver.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Ann Arbor Healthcare System

Ann Arbor, Michigan, 48113-0170, United States

Location

VA Medical Center, Cleveland

Cleveland, Ohio, 44106, United States

Location

Related Publications (3)

  • Piette JD, Rosland AM, Marinec NS, Striplin D, Bernstein SJ, Silveira MJ. Engagement with automated patient monitoring and self-management support calls: experience with a thousand chronically ill patients. Med Care. 2013 Mar;51(3):216-23. doi: 10.1097/MLR.0b013e318277ebf8.

    PMID: 23222527RESULT

  • Piette JD, Striplin D, Marinec N, Chen J, Aikens JE. A randomized trial of mobile health support for heart failure patients and their informal caregivers: impacts on caregiver-reported outcomes. Med Care. 2015 Aug;53(8):692-9. doi: 10.1097/MLR.0000000000000378.

    PMID: 26125415DERIVED

  • Piette JD, Striplin D, Marinec N, Chen J, Trivedi RB, Aron DC, Fisher L, Aikens JE. A Mobile Health Intervention Supporting Heart Failure Patients and Their Informal Caregivers: A Randomized Comparative Effectiveness Trial. J Med Internet Res. 2015 Jun 10;17(6):e142. doi: 10.2196/jmir.4550.

    PMID: 26063161DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Results Point of Contact

Title
Dr. John Piette, PhD
Organization
Ann Arbor VA Healthcare System
jpiette@umich.edu
734-845-3626

Study Officials

  • John D. Piette, PhD

    VA Ann Arbor Healthcare System

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

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

Study Record Dates

First Submitted

November 6, 2007

First Posted

November 8, 2007

Study Start

June 1, 2009

Primary Completion

January 1, 2013

Study Completion

December 1, 2014

Last Updated

September 15, 2015

Results First Posted

September 15, 2015

Record last verified: 2015-08

Locations

US(2)