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

Primary Purpose

Heart Failure, Comorbidity, Case-manager

Status

Completed

Phase

Not Applicable

Locations

Spain

Study Type

Interventional

Intervention

Disease management program

Usual care

About this trial

This is an interventional supportive care trial for Heart Failure focused on measuring Heart failure, Elderly, Disease management

Eligibility Criteria

75 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Hospital Meixoeiro

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Lifestyle counselling

Comparator

Arm Description

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

Usual care

Outcomes

Primary Outcome Measures

Mortality or readmission

Secondary Outcome Measures

Health related quality of life

Full Information

NCT ID

NCT01076465

First Posted

February 25, 2010

Last Updated

April 16, 2016

Sponsor

Hospital de Meixoeiro

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT01076465

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

October 2009 (undefined)

Primary Completion Date

November 2013 (Actual)

Study Completion Date

November 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Hospital de Meixoeiro

Collaborators

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

4. Oversight

Data Monitoring Committee

5. Study Description

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: patient education to improve disease' knowledge and self-care monitoring of clinical status 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Heart Failure, Comorbidity, Case-manager

Keywords

Heart failure, Elderly, Disease management

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

700 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Lifestyle counselling

Arm Type

Experimental

Arm Description

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

Arm Title

Comparator

Arm Type

Active Comparator

Arm Description

Usual care

Intervention Type

Other

Intervention Name(s)

Disease management program

Intervention Description

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

Behavioral

Intervention Name(s)

Usual care

Intervention Description

Usual care

Primary Outcome Measure Information:

Title

Mortality or readmission

Time Frame

one year

Secondary Outcome Measure Information:

Title

Health related quality of life

Time Frame

one year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Hospital Meixoeiro

City

Vigo

State/Province

Pontevedra

ZIP/Postal Code

36200

Country

Spain

12. IPD Sharing Statement

Citations:

PubMed Identifier

21819564

Citation

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.

Results Reference

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

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