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NCT Number: NCT01076465

Efficacy of a Disease Management Program in Very Old Patients With Heart Failure

The purpose of this study is to assess the efficacy of a disease management programme (DMP) for very old patients with HF and significant co-morbidity.

METHODS: A multicenter randomized trial will be conducted with 700 patients with heart failure, aged over 75 years, admitted to the acute-care units of the Geriatrics Departments in 8 hospitals. Patients will be randomly allocated to a DMP or to conventional usual-care. Randomization will be stratified by hospital and performed with concealment of the allocation list.

The DMP will be conducted by a case manager, and will include three main components:

1. patient education to improve disease' knowledge and self-care 2. monitoring of clinical status 3. therapeutic adherence. Main statistical analyses will be performed according to the intention-to-treat principle, and will use Cox regression models to examine the association of a DMP with hospital readmission, quality-of-life, and mortality over 12 months.

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Key information

Conditions

Heart Failure Cardiovascular Diseases Case-manager Comorbidity Heart Diseases

Age range

75 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Meixoeiro

Vigo, Pontevedra, 36200, Spain

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age:75 y or older
  • Co-morbidity or dependency. At least one of the following criteria: Charlson index >3, dependency in 2 or more basic activities of daily living,treatment with 5 or more drugs, urgent hospitalization in the last 3 months, three or more diseases with active treatment, limitation in daily living because of vision or hearing impairment, cognition deficit, Parkinson disease, diabetes mellitus, chronic obstructive lung disease, severe anemia, constitutional syndrome
  • Hospital admission with a main diagnosis of heart failure (according to the criteria of the European Society of Cardiology or Framingham criteria) in NYHA functional class II-IV.

Exclusion criteria

  • Participation refusal
  • Terminal illness
  • Cognitive decline or severe cognitive deficit, which does not permit a minimum knowledge of the disease, or lack of carers which give consent to study participation
  • Clinical instability as assessed with the Kosecof index
  • Being in waiting list for organ transplant or cardiac surgery
  • Inability to be followed-up because of other reasons (change of place of residence,..)
  • Institutionalization

Treatment and study plan

Disease management program

Other
  • Educational intervention on management of heart failure and comorbidity to improve patient's knowledge of his/her disease and self-care 2) Monitoring of clinical status 3) Monitoring and improvement of therapeutic adherence.

Usual Care

Behavioral

Usual care

Primary outcomes

  1. Mortality or readmission

    Time frame: one year

Secondary outcomes

  1. Health related quality of life

    Time frame: one year

Sponsors and collaborators

Lead sponsor

Hospital de Meixoeiro

Other Gov

Collaborators

  • Complejo Hospitalario Universitario de Vigo
  • Fondo de Investigacion Sanitaria
  • Universidad Autonoma de Madrid

Registry information

Official study title

Efficacy of a Disease Management Program in Very Old Patients With Heart Failure and Significant Comorbidity: a Multicenter Randomized Trial

Important dates

Study start
2009
Primary completion
2013
Study completion
2013
First posted
Feb 26, 2010
Registry last updated
Apr 19, 2016

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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