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

Heart Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01076465
• Other study ID #: PI081280
• Secondary ID: PI081280
• Status: Completed
• Phase: N/A
• First received: February 25, 2010
• Last updated: April 16, 2016
• Start date: October 2009
• Est. completion date: November 2013

Study information

• Verified date: June 2011
• Source: Hospital de Meixoeiro
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics CommitteeSpain: Ministry of HealthSpain: Instituto de Salud Carlos III
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 700
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 75 Years and older

Eligibility

Inclusion Criteria:

1. Age:75 y or older

2. 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

3. 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:

1. Participation refusal

2. Terminal illness

3. 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

4. Clinical instability as assessed with the Kosecof index

5. Being in waiting list for organ transplant or cardiac surgery

6. Inability to be followed-up because of other reasons (change of place of residence,..)

7. Institutionalization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Case-manager
• Comorbidity
• Heart Failure

Intervention

Other:
• Disease management program
1. 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.

Behavioral:
• Usual care
Usual care

Locations

Country	Name	City	State
Spain	Hospital Meixoeiro	Vigo	Pontevedra

Sponsors (4)

Lead Sponsor	Collaborator
Hospital de Meixoeiro	Complexo Hospitalario Universitario de Vigo, Fondo de Investigacion Sanitaria, Universidad Autonoma de Madrid

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality or readmission		one year	No
Secondary	Health related quality of life		one year	No