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

NCT ID: NCT01076465

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 700 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2013-11-30

Brief 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.

Conditions

Heart Failure; Comorbidity; Case-manager

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Lifestyle counselling

Educational intervention, monitoring of clinical status, monitoring of treatment adherence

Group Type: EXPERIMENTAL

Disease management program

Intervention Type: OTHER

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.

Comparator

Usual care

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Usual care

Interventions

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.

Intervention Type: OTHER

Usual care

Usual care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Complejo Hospitalario Universitario de Vigo

OTHER

Sponsor Role: collaborator

Universidad Autonoma de Madrid

OTHER

Sponsor Role: collaborator

Fondo de Investigacion Sanitaria

OTHER

Sponsor Role: collaborator

Hospital de Meixoeiro

OTHER_GOV

Sponsor Role: lead

Responsible Party

Carlos RodrÃ-guez Pascual

MD, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hospital Meixoeiro

Vigo, Pontevedra, Spain

Countries

Spain

References

Pascual CR, Galan EP, Guerrero JL, Colino RM, Soler PA, Calvo MH, Jaurieta JJ, Arambarri JM, Casado JM, Rodriguez-Artalejo F. Rationale and methods of the multicenter randomised trial of a heart failure management programme among geriatric patients (HF-Geriatrics). BMC Public Health. 2011 Aug 5;11:627. doi: 10.1186/1471-2458-11-627.

Reference Type: DERIVED

PMID: 21819564 (View on PubMed)

Other Identifiers

PI081280

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PI081280

Identifier Type: -

Identifier Source: org_study_id