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ID
Source
Brief title
Health condition
Heart failure
Sponsors and support
Intervention
Outcome measures
Primary outcome
Observational study: quality of life (Minnesota Living with Heart Failure Questionnaire (MLHFQ) and ability of self-care (European Heart Failure Self-care Behaviour Scale)
Secondary outcome
Observational study: hospitalization for worsening heart failure during one year of follow-up
Background summary
Background: Despite great progress in the areas of knowledge, prevention, research, treatment and counseling of patients with chronic heart failure, there is still a high burden of disease and premature death.
Heart failure can occur at all ages, but is a prevalent condition in the elderly, often with multiple diseases. In the case of frail older people, heart failure can have an even greater influence on self-care and quality of life. Increased vulnerability can also lead to more hospital admissions and re-admissions due to disrupted heart failure.
Objective: To determine the degree of vulnerability (fragility), self-care, quality of life and their mutual influences in elderly patients with chronic heart failure, and the relationship with hospital (re) admission within one year.
Study design: An exploratory, prospective, observational cohort study, in one center (ZGT: Hospital Group Twente, Almelo and Hengelo, The Netherlands).
Study population: Patients with stable chronic heart failure, who are 70 years of age or older, and who are being treated in the ZGT heart failure outpatient clinic. A total of 250 patients will participate in the study.
Key study parameters: During a visit to the Heart Failure Outpatient Clinic, medical examination, physical history and ECG are performed in the context of regular patient care. Standard blood taken to check for kidney function, electrolytes, and NT-proBNP. Patients are asked to complete questionnaires about their heart failure, self-care and quality of life. They are also asked to undergo geriatric and cognitive function tests. These form a basis for the degree of fragility. The course can be analyzed by repeated testing during the individual 1-year study period.
Patient burden: Completing the questionnaires takes approximately 20 minutes. The geriatric and cognitive function tests last approximately 1 hour. The physical tests (duration around 30 minutes) are placed under the physioconsult standard care.
Participation is voluntary and there are no risks associated with the research. Patients can stop participating in the study at any time during the study without giving a reason and without consequences for further treatment and care.
Public summary Heart failure is a disease with a high disease burden that occurs in more than 10% of people over seventy in the Netherlands. Most have multiple diseases and use many different drugs, which makes heart failure care complex. Counseling in a heart failure outpatient clinic can improve disease insight and therapy compliance (self-care). Increased vulnerability and mental and / or physical decline often occur in people over the age of seventy. This can have a negative impact on their self-care and there is more chance of heart failure being disrupted.
The aim of our research, to determine the degree of vulnerability, self-care and quality of life in 250 elderly patients with heart failure. We also investigate the mutual influences of these aspects and what the chance is of hospitalization. Participation is voluntary and there are no risks involved.
Study objective
The degree of vulnerability (fragility) negatively impacts self-care, quality of life and their mutual influences in elderly patients with chronic heart failure, and the relationship with hospital (re) admission within one year.
Study design
Baseline, 3, 6 and 12 months.
Intervention
None
Gerard Linssen
+31887083346
g.linssen@zgt.nl
Gerard Linssen
+31887083346
g.linssen@zgt.nl
Inclusion criteria
In order to be eligible to participate in this study, a subject must meet all of the following criteria:
1. Stable, chronic heart failure (systolic or diastolic) based on an underlying heart disease diagnosed by the cardiologist
2. Healthcare in the setting of the Heart Failure Outpatient Clinic in ZGT (Hospital Group Twente, Almelo and Hengelo, The Netherlands)
3. Age >= 70 years
4. Being able to read and write Dutch
5. Written informed consent obtained
Exclusion criteria
1. Patients who were previously admitted to an institution for elderly care or nursing home or hospice
2. Patients included in a study medication trial
3. Patients who have had heart surgery or other major surgery or surgery in the previous 4 weeks
4. Patients on the waiting list for heart transplantation or heart pump (LV assist device)
5. Patients undergoing kidney dialysis
6. Patients with moderate to severe dementia
7. Patients for whom an abstinent policy has been chosen
Design
Recruitment
IPD sharing statement
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Other (possibly less up-to-date) registrations in this register
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In other registers
Register | ID |
---|---|
NTR-new | NL8442 |
Other | Advisory committee Medisch Spectrum Twente at Enschede, the Netherlands : K20-13 |