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

Not Applicable

Completed

• Conditions: Comorbidity; Case-manager; Heart Failure
• Interventions: Behavioral: Usual care; Other: Disease management program

• Registration Number: NCT01076465
• Lead Sponsor: Hospital de Meixoeiro

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-02-25
• Study First Submitted QC: 2010-02-25
• Study First Posted: 2010-02-26
• Status Verified: 2011-06
• Primary Completion: 2013-11
• Study Completion: 2013-11
• Last Update Submitted: 2016-04-16
• Last Update Posted: 2016-04-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 700

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparator	Usual care	Usual care
Lifestyle counselling	Disease management program	Educational intervention, monitoring of clinical status, monitoring of treatment adherence

Primary Outcome Measures

Name	Time	Method
Mortality or readmission	one year

Secondary Outcome Measures

Name	Time	Method
Health related quality of life	one year

Trial Locations

Locations (1)

Hospital Meixoeiro; 🇪🇸 Vigo, Pontevedra, Spain