University Hospital of Montpellier Cardiology departments oh the Montpellier, Nîmes and Toulouse University Hospitals
Montpellier, Occitanie, 34295, France
NCT Number: NCT03902028
This is a controlled, randomized, open-label, multicentric study evaluating the value of coordinated medico-pharmaceutical management compared to standard management in patients with heart failure. The aim of this study is to evaluate the impact of these optimized activities on the re-hospitalization of the patient with cardiac insufficiency for a disease-related event within three months of the initial hospitalization.
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Notify Me18 year and older
All sexes
Interventional
Not applicable
Montpellier, Occitanie, 34295, France
Heart failure (FH) is a public health problem with an estimated prevalence of about 1.5% in developed countries. In 2013, the number of patients hospitalized in France for heart failure amounted to 165 231 and 20% of them were re-hospitalized at least once for the same reason during this year. Several factors contribute to the occurrence of cardiac decompensation (DC) : some modifiable (age, severity of IC, etiology ...) and others modifiable, such as therapeutics. Various elements could reduce the frequency of re-hospitalizations and the mortality due to this disease :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Reinforced multidisciplinary follow-up
Time frame: Call at 3 months after hospitalisation discharge
At least one rehospitalisation with heart failure related cause
Time frame: At hospitalisation discharge (Day 0)
Evaluated by a pharmacist
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Time frame: At hospitalisation discharge (Day 0)
Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Time frame: At 1 month after hospitalisation discharge for the experimental group only
Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by the "Girerd medication adherence questionnaire" Evaluated by the " Girerd medication adherence questionnaire "
The " Girerd medication adherence questionnaire " contains 6 questions which answers are " yes " or " no ". The number of " yes " responses permits to evaluate the level of the patient medication adherence as following :
0 yes : good compliance
1 or 2 yes : minor non compliance 3 or more yes : non compliance
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by a pharmacist
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by the Minnesota Living with Heart Failure Questionnaire the Minnesota Living with Heart Failure Questionnaire contains 21 questions. Each of the 21 questions ask the patients to indicate how much a possible effect of heart failure have affected their ability to live as wanted during the past month using a scale from 0 (not present or no effect), 1 (very little), 2, 3, 4, or 5 (very much).The measurement of heart failure severity is assessed by summing the responses that ranges from 0 to 105.
Time frame: Call at 3 months after hospitalisation discharge
Evaluated by Likert scale This questionnaire indicates the degree of patient satisfaction using 9 questions which explore the improvement of patient behavior concerning disease and treatment. The measurement of satisfaction is assessed by summing the responses that range from 9 (unsatisfied) to 36 (very satisfied)
Time frame: online questionnaire at 3 months after hospitalisation discharge
Evaluated by Likert scale (only for interventional arm) This questionnaire indicates the degree of health professional satisfaction using 6 questions which explore the improvement of transition between hospital to community and comprehension of therapeutic optimization. The measurement of satisfaction is assessed by summing the responses that range from 6 (unsatisfied) to 24 (very satisfied)
Time frame: 3 months after hospitalisation discharge
University Hospital, Montpellier
Other
Interest of an Optimized Medico-pharmaceutical Collaboration in the Drug Management of Patients With Heart Failure: Controlled, Randomized, Multicentric Study
Acronym: COMPIC
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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