The objectives of this study are (1) to determine the contribution of psychological factors in the prediction of prognosis, health care utilization, and quality of life (2) to identify biological and psychological mechanisms that can explain the…
ID
Source
Brief title
Condition
- Heart failures
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Personality (Type D and hostility) and mood are independent predictive
variables. Mediating variables are immunoparameters and psychological variables
(self-management and loneliness). Moderators are medical on the one hand (NYHA
class, etiology), and psychological on the other hand (positive affectivity,
sense of coherence and marital satisfaction). Primairy outcomes are defined as
quality of life, health care utilization, and the combined endpoint of
mortality and rehospitalizations.
Secondary outcome
The secundary endpoint is defined as cardiac mortality.
Background summary
Heart failure poses a significant burden on patients, partners and health care.
Traditional prognostic risk factors are identified, however little is known
about the role of psychological variables.
Study objective
The objectives of this study are (1) to determine the contribution of
psychological factors in the prediction of prognosis, health care utilization,
and quality of life (2) to identify biological and psychological mechanisms
that can explain the influence of predictors, and (3) to identify moderators of
psychological risk factors.
Study design
Participants are introduced to the study at consultation of the cardiologist or
heart failure nurse. The researcher invites participants to participate in the
study. Both patients, as well as partners participate on voluntary base. Data
is gathered at baseline, 6, 12, and 18 month follow-up in patients, in partners
at baseline and 12 month follow-up.
Study burden and risks
The study is observational, with minimal invasive procedures (blood samples are
taken from patients), carried out bij qualified personnel. Furthermore, the
study consists of filling out questionnaires. The duration of filling out
questionnaires varies between 30 and 60 minutes. Finally, in patients exercise
tests are carried out.
Postbus 90153
5000 LE Tilburg
Nederland
Postbus 90153
5000 LE Tilburg
Nederland
Listed location countries
Age
Inclusion criteria
Patients:
Systolic heart failure; LVEF<40%; stable on oral medication during one month; no medical admissions during one month; functional NYHA-class I-III; sufficient understanding of written and spoken Dutch language.;Partners:
Having a relation with the patient and living together, sufficient understanding of written and spoken Dutch language.
Exclusion criteria
Patients:
Age >80 years; myocardial infarction during the month of inclusion; other life-threatening diseases; clinical signs of acute infection; co-morbid chronic inflammatory or auto-immune disease (e.g. Rheumatoid Arthritis); use of substantial anti-inflammatory medication (e.g. cortisol); evident cognitive impairments; chronic severe psychiatric condition (e.g. psychosis).;Partners:
Evident cognitive impairments; chronic severe psychiatric condition (e.g. psychosis).
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL11118.008.06 |