N/A
N=14
Chronic Kidney Disease Among Frail Elderly
Chronic Kidney Disease
Bottom Line
View on ClinicalTrials.gov: NCT02351349 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
May 2021
Primary outcome: Primary: Mortality — 0; 0 percentage of mortality
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- multidisciplinary intervention (Other)
- Age
- Older Adult · 65+ yrs
- Sex
- All
- Sponsor
- Sameena Iqbal
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mortality |
0; 0 | — |
| SECONDARY Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation). |
0; 0 | — |
| SECONDARY Hospitalizations |
0; 0 | — |
| SECONDARY Physical Functioning Measures |
5; 5.3; 3.9; 5.5 | 0.0143 sig |
| SECONDARY Time up and go |
12; 13; 10.8; 13.3 | 0.1416 |
| SECONDARY Dominant Hand Grip |
23; 19; 26.5; 20 | 0.9013 |
Summary
Chronic kidney disease is a common diagnosis in the elderly population and it is associated with significant morbidity and health care costs. The prevalence rates increase with age to about 40% for adults aged > 65 years. In the elderly population (age 65 and over), CKD is associated with a higher burden of comorbid conditions and frailty. The prevalence of frailty is higher in CKD patients with rated being double in early stages and nearly 6 times higher beyond stage 3b. Previously reported frailty mortality rates of 18% at 3 years and 47% at 7 years comparing with mortality rates in non frail individuals of 3% and 12% respectively. In this study, the investigators investigate the effect of multidisciplinary interventions upon frail elderly patients with CKD not yet on dialysis. This interventions include best medical care, nutrition, physiotherapy, and social, psychological and spiritual support.
Eligibility Criteria
Inclusion Criteria
- Eligible participants must be ≥65 years as of December 2014, with estimated glomerular filtration rate (eGFR) of ≤30ml/min, and experiencing frailty defined as 3 out of 5 criterias: unintentional weight loss (self-reported or January 11, 2015 revised objective 10 lbs in past year)
- Self-reported exhaustion
- Weakness (measured by grip strength)
- Slow walking speed (measured by the 6 minute walking test)
- Low physical activity.
Exclusion Criteria
- Exclusion criteria are: persons aged <65
- Unable to grasp dynamometer due to various reasons
- Expected life expectancy <6 months due to a non-renal cause
- Patient refusal to participate
- Plan to travel or transfer treatment site during study period and unable to be contacted
- Severe cognitive impairment (as screened with MoCA <18).
Data sourced from ClinicalTrials.gov (NCT02351349). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.