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Chronic Kidney Disease Among Frail Elderly (FRED-CKD)

24 de mayo de 2021 actualizado por: Sameena Iqbal

MULTIDISCIPLINARY INTERVENTION FOR FRAIL ELDERLY PATIENTS WITH STAGE 4 or 5 Chronic Kidney Disease (Not on Dialysis)

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.

Descripción general del estudio

Estado

Terminado

Intervención / Tratamiento

Descripción detallada

A multilevel, multidisciplinary intervention is required to assist frail CKD patients given the complexity of their condition. However, the optimal methods for this intervention are not very well defined in the literature.

It was previously described that dialysis does not improve (and often times can worsen) the outcomes of frail patients with renal disease (41). The nowadays trend is to try to optimise and decrease frailty before initiation of dialysis. If that is not possible, a more conservative and palliative approach is envisaged. Regardless, a combined geriatric and nephrological expertise may help to identify patients at high risk of early death for whom this approach is indicated (42).

Major medical societies have regularly reviewed and published their guidelines for medical management of chronic kidney disease. Most reputable such guidelines are KDIGO 2012 Clinical Practice Guideline for the Evaluation and Management of Chronic Kidney Disease (43) and The National Kidney Foundation Kidney Disease Outcomes Quality Initiative (NKF KDOQI, (44)). In Canada, field experts reviewed current evidence and provided similar recommendations (45). In summary, all this guidelines provide expert opinion on treatment and targets of treatment in CKD patients with an accent on controlling cardiovascular risk factors (hypertension, diabetes, dyslipidemia), lifestyle management, control of CKD complications (proteinuria, anemia, mineral metabolism), and initiation of renal replacement therapy.

Lifestyle management is probably one of the most important intervention in CKD population. First and foremost, it empowers the patients to take control of their lives and become an active partner in their treatment. Smoking cessation, weight reduction, dietary protein control, alcohol intake, exercise, and controlling salt intake are proven to improve outcomes and are part of current guidelines. Regular physical exercise improves physical fitness, walking capacity, cardiovascular parameters (e.g. blood pressure and heart rate), health-related quality of life, and nutritional parameters (48). Physical activity is also protective against depression (49). In the case of frail patients, usually sedentary, with multiple cardiac risk factors, it is recommended to begin with gradual exercise and under supervision.

Nutrition must be targeted in the frail elderly with CKD because decreasing energy intake is associated with higher stages of CKD (50). Though in the CKD non dialysis population, nutrition supplementation has not been formally assessed, the general population of frail elderlies have been evaluated with protein supplementation.

Tieland et al (51) randomized 65 frail elderly in protein versus placebo supplementation groups for 24 weeks. January 11, 2015 revised The protein supplementation group had no benefit with respect to weight gain or muscle strength. However, when resistive exercise training was coupled with protein supplementation, body weight gain was achieved.

Furthermore, Tieland et al (52) randomized 62 frail elderly in two groups, both who received exercise training but only one group received protein supplements. A 0.7 kg weight gain was recorded in the protein supplement but none in the control group. The sustainability and the benefit in survival of such weight gain has not been determined, especially in the CKD non dialysis patients. Thus, the investigators propose that exercise with protein supplementation will benefit the CKD frail older population.

Frail patients with or without CKD are at risk of experiencing psychological distress. Acknowledging one's own limitations, inability to perform up to certain social standards, losing function when comparing with friends or family members within same age group, depending on other's support can all be envisage as high risk factors for depression and/or other psychological ailments. Psychological distress is associated decrease quality of life of worse outcomes. Anxiety and depression are 2 major compounds of psychological distress. Patients can be screened with two easy to use scales: GAD-7 (for anxiety) and PHQ-9 (for depression). Were identified, these conditions should be treated by Psychiatry or Geriatrics services.

Disability is best assessed using the standard ten variables addressed in the Barthel scale (56) are: presence or absence of fecal incontinence, presence or absence of urinary incontinence, help needed with grooming, help needed with toilet use, help needed with feeding, help needed with transfers (e.g. from chair to bed), help needed with walking, help needed with dressing, help needed with climbing stairs, and help needed with bathing. The Maryland State Medical Society holds the copyright for the Barthel Index. It may be used freely for noncommercial purposes with the following citation: Mahoney FI, Barthel D. "Functional evaluation: the Barthel Index." Maryland State Med Journal 1965;14:56-61. The scale is detailed in Appendix 2 and it is used with permission.

Interventions targeted to improve frailty are limited by the patient's ability to collaborate and work with the treating team. Severe cognitive impaired patients lack insight and capacity and they are limited in their capacity to rehabilitated. MoCA (57) is a well validated tool at identifying cognitive impairment, it is widely available in many languages, and it is recommended by The Canadian Consensus Guidelines for Diagnosis and Treatment of Dementia for detection of Mild Cognitive Impairment and Alzheimer's disease. A cut-off of > 17 is generally used to exclude severe dementia. A language specific MoCA and instructions to administer the test are available online at http://www.mocatest.org/. The original English version is reproduced in Appendix 3.

The primary objective of the proposed study is to assess the effect of intensive multidisciplinary interventions on survival, hospitalization and need to start dialysis. Secondary objectives include the assessment of the intervention in different stages of sarcopenia and measurement of physical functioning and nutritional parameters to evaluate the effect of such interventions among the frail CKD population.

Tipo de estudio

Intervencionista

Inscripción (Actual)

14

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Quebec
      • Montreal, Quebec, Canadá
        • McGill University Health Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: multidisciplinary intervention
Due to the problem of randomization, the study became a before and after assessment in the one group that completed the 12 week exercise program and received nutritional support
multidisciplinary intervention
Otros nombres:
  • fisioterapia
  • nutritional therapy
  • supportive therapy
Sin intervención: Non adherence
Those who were offered the program but did not complete the prescription

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mortality
Periodo de tiempo: 6 months

the entire sample will be followed until time of death or until study completed. The cause of

death will be determined from proxies or from hospital records.

6 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).
Periodo de tiempo: 6 months
Number of patients progressed to the need for renal replacement therapy (any modality or palliation).
6 months
Hospitalizations
Periodo de tiempo: 6 months
information about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies
6 months
Physical Functioning Measures
Periodo de tiempo: 12 weeks
assessed by applying the data of the 4 meter walk compared between the two study groups.
12 weeks
Time up and go
Periodo de tiempo: 12 weeks
one of the physical functioning parameters
12 weeks
Dominant Hand Grip
Periodo de tiempo: 12 weeks
right hand grip average of three values
12 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Sameena Iqbal, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de enero de 2016

Finalización primaria (Actual)

15 de diciembre de 2016

Finalización del estudio (Actual)

15 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

27 de enero de 2015

Primero enviado que cumplió con los criterios de control de calidad

29 de enero de 2015

Publicado por primera vez (Estimar)

30 de enero de 2015

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

26 de mayo de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

24 de mayo de 2021

Última verificación

1 de mayo de 2021

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 14-275-GEN

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre multidisciplinary intervention

3
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