No registrations found.
ID
Source
Brief title
Health condition
End stage renal disease
Sponsors and support
Intervention
Outcome measures
Primary outcome
QoL measured with CKD-PROMs (consisting of SF-12 and Dialysis Symptom Index)
Secondary outcome
Clinical outcomes (independent functionality, hospitalisation, mortality), cost-effectiveness and decisional regret
Background summary
In 2016 almost 50% of the incident dialysis patients were >70 yrs of age. In this group, mortality in the first year is high (24%) and after 5 yrs 74% has died. Furthermore, there is an increasing percentage of patients withdrawing from dialysis treatment, and in dialysis patients >65 yrs withdrawal is with 30% the most prevalent cause of death since 2013. These data ask for a better identification of older patients for whom not starting dialysis but instead conservative care (CC) may be a better option than
starting dialysis.
In the present project we aim to compare quality of life (QoL), clinical outcomes, and costs of CC and dialysis in older patients with ESRD, and aim to associate clinical and geriatric patient characteristics in the decision making trajectory with these outcomes, which could help to identify patients for whom CC might be a better option than starting dialysis.
Study objective
Nephrogeriatric assessment will be beneficial in identifying patients for whom conservative care might be a better option (QoL, clinical outcomes, costs) than starting dialysis.
Study design
Once-yearly till end of follow up (depending on the moment of inclusion follow-up can vary from a minimum of 1 year to a maximum of 4 years )
Intervention
• Katz ADL-6
• Lawton iADL
• Hand grip strength
• Fall risk
• Montreal Cognitive Assessment (MOCA)
• Letter Digit Substraction Test (LDST)
• 6-item Cognitive Impairment Test (6CIT)
• Geriatric Depression Scale (GDS-2; GDS-15 if positive)
• Optimism check
• Surprise question
• Clinical Frailty Score
• Charlson co-morbidity index
• Mini Nutritional Assessment (MNA)
• EQ5D-5L
• iMTA Costs
• Short Form-12 (SF-12)
• Dialysis Symptom Index (DSI)
• Decisional regret questionnaire
Inclusion criteria
1. Age > 65 years
2. eGFR 10-20 ml/min/1.73m2 (at least during 1 measurement in 3 months before inclusion)
Exclusion criteria
- Unwilling or unable to provide (written) informed consent
- Illiterate
- If a patient appears to be severely cognitive impaired after evaluation of the cognitive function, the patient will be consulted by a geriatrician for further clinical evaluation, such as the presence of dementia. In case of diagnosis of cognitive impairment, the geriatrician will judge if patient is mental competent (“wilsbekwaam”) to provide informed consent to partici-pate in the study. If not, the patient will not be prospectively followed and no blood sample will be collected.
Design
Recruitment
IPD sharing statement
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 |
|---|---|
| NTR-new | NL8352 |
| Other | METC ZWH : 19 – 071 |