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Effectiveness of a Multidisciplinary Care Management Program for High-risk Patients With Heart Failure (PROMIC)

NCT02436161 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 250

Last updated 2015-05-06

No results posted yet for this study

Summary

OBJECTIVE: To evaluate the effectiveness of a multidisciplinary care management collaborative program for high-risk patients with heart failure (HF) who are admitted at hospital, based on the 6 components of the Chronic Care Model "PROMIC", in terms of reduction of a Combined event rate (readmissions / cardiac events / death / emergency department visits) and other variables, the feasibility of the program, the improvement on quality of life related to health and functional capacity of the PROMIC patients compared with control patients in usual care.

DESIGN: A quasi-experimental, prospective one year follow-up study. SETTING AND SUBJECTS: Primary Health care Centres of Interior County in Bizkaia and of Araba County in Araba, Galdakao Hospital, Santa Marina Hospital and University hospital os Araba in the Basque Country. Will be captured as a minimum intervention group of 125 patients admitted for HF in New York Heart Association (NYHA) functional status II-III-IV from previous mentioned hospitals. Another 125 patients from different primary health care centers, will be the control group.

INTERVENTION: The intervention to be applied will be PROMIC, control patients will receive usual care MEASUREMENTS: The mean outcome measure will be the time free of events from the time of inclusion to the first event (readmission / cardiac events / death / emergency visits). Secondary endpoints will be the quality of life related to health (MLFHQ and SF-12), functional capacity (6-Minute Walk Test), structural changes in cardiac structure (natriuretic peptide levels), adherence to drug treatment (Morinsky-Green), the cost of the program, the usefulness and acceptability of PROMIC by professionals and patients. Predictor variables also will be collected such as sex, age, education level, co-morbidity, social risk level, dependency etc.

STATISTICAL ANALYSIS: Analysis was performed by intention to treat. Survival curves will done. A model of Cox proportional hazards will be built.

Conditions

Interventions

BEHAVIORAL

Care management program "PROMIC"

intensive coaching intervention to optimize care and prevent readmissions, using educational selfcare and worsening symptoms recognition by patients and carers

Sponsors & Collaborators

  • Basque Health Service

    lead OTHER_GOV

Principal Investigators

  • Cristina Domingo, MD, FAM PHY · Basque Health Service

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-05-31
Completion
2015-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02436161 on ClinicalTrials.gov