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OpenTrials
Completed

NCT Number: NCT00439842

Self-Management and Care of Heart Failure With Group Clinics (SMAC-HF)

The purpose of this study is to help people with heart failure (HF) to manage their HF and to prevent rehospitalizations. Another purpose is to test the usefulness of clinical appointments and educational videotapes in teaching patients how to manage their HF.

It is proposed that the group clinic intervention (HFcareGroup)will reduce rehospitalization, depression, and improve problem solving related to heart failure symptoms.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

About this study

Aim 1 Hypothesis:

  • The time to the 1st composite endpoint (HF Rehospitalization/death) will be longer for HFcareGroup than standard care group at 12 months.
  • The HFcareGroup will have higher score than standard care on patient outcomes i.e. functional health status, quality of life, satisfaction with health care at 12 months.
  • Health Services Use will be lower in HFcareGroup than standard care group at 12 months.

Aim 2 Hypothesis:

  • The HFcareGroup will have higher score than standard care on patients' HF self-management i.e., self-care behaviors, participation with health care professionals in HF management and problem-solving, HF knowledge and preparedness for home care at 6 and 12 months.
  • A greater proportion of HFcareGroup vs standard care subjects will report clinical or symptoms of HF decompensation (e.g. specific weight gain, shortness of breath, edema, fatigue, tachycardia, and medication side effects) to their health care provider.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 years or older
  • speak English/Spanish
  • receiving treatment for congestive heart failure
  • receiving IV diuretics
  • 2 or more HF symptoms
  • be able to participate in follow up visits

Exclusion criteria

  • primary right-sided heart failure
  • HF transient & related to acute MI
  • HF due to correctable cause
  • being scheduled for coronary revascularization or any readmission
  • receiving infusion for HF therapy within 2 weeks
  • having co-morbidities, life expectancy < 12 months
  • severe cognitive impairment
  • D/C to nursing facilities or rehab unit
  • Currently enrolled in an intervention study or HF management program
  • being or planning to become pregnant within 12 months
  • severe cognitive impairment

Treatment and study plan

Heart Failure Group Clinic Appointments

Behavioral

Self Management and Care of Heart Failure with Group Clinics (SMAC-HF)

Other names: HFcareGroup

Primary outcomes

  1. rehospitalization or death

    Time frame: 12 months

Secondary outcomes

  1. HF self-management:problem-solving, self-care behaviors

    Time frame: 6 and 12 months

  2. heart failure knowledge and preparedness for home care

    Time frame: 6 and 12 months

  3. functional health status, quality of life, satisfaction with health care, health services use

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Carol Smith, RN, PhD, FAAN

Other

Collaborators

  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

HF Group Clinic Appointments: Rehospitalization Prevention

Important dates

Study start
2007
Primary completion
2013
Study completion
2014
First posted
Feb 26, 2007
Registry last updated
Apr 17, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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