NCT01076465

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. 1.patient education to improve disease' knowledge and self-care
  2. 2.monitoring of clinical status
  3. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for not_applicable heart-failure

Timeline
Completed

Started Oct 2009

Longer than P75 for not_applicable heart-failure

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 26, 2010

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 19, 2016

Status Verified

June 1, 2011

Enrollment Period

4.1 years

First QC Date

February 25, 2010

Last Update Submit

April 16, 2016

Conditions

Heart FailureComorbidityCase-manager

Keywords

Heart failureElderlyDisease management

Outcome Measures

Primary Outcomes (1)

  • Mortality or readmission

    one year

Secondary Outcomes (1)

  • Health related quality of life

    one year

Study Arms (2)

Lifestyle counselling

EXPERIMENTAL

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

Other: Disease management program

Comparator

ACTIVE COMPARATOR

Usual care

Behavioral: Usual care

Interventions

Disease management programOTHER

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.

Lifestyle counselling
Usual careBEHAVIORAL

Usual care

Comparator

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Meixoeiro

Vigo, Pontevedra, 36200, Spain

Location

Related Publications (1)

  • 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.

    PMID: 21819564DERIVED

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

February 25, 2010

First Posted

February 26, 2010

Study Start

October 1, 2009

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 19, 2016

Record last verified: 2011-06

Locations

ES(1)