- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT02351349
Chronic Kidney Disease Among Frail Elderly (FRED-CKD)
MULTIDISCIPLINARY INTERVENTION FOR FRAIL ELDERLY PATIENTS WITH STAGE 4 or 5 Chronic Kidney Disease (Not on Dialysis)
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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Quebec
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Montreal, Quebec, Canada
- McGill University Health Center
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-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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).
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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
Altri nomi:
|
Nessun intervento: Non adherence
Those who were offered the program but did not complete the prescription
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Mortality
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).
Lasso di tempo: 6 months
|
Number of patients progressed to the need for renal replacement therapy (any modality or palliation).
|
6 months
|
Hospitalizations
Lasso di tempo: 6 months
|
information about principal diagnosis, number and length of hospitalizations will be collected at 6-month intervals from participant, from proxies
|
6 months
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Physical Functioning Measures
Lasso di tempo: 12 weeks
|
assessed by applying the data of the 4 meter walk compared between the two study groups.
|
12 weeks
|
Time up and go
Lasso di tempo: 12 weeks
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one of the physical functioning parameters
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12 weeks
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Dominant Hand Grip
Lasso di tempo: 12 weeks
|
right hand grip average of three values
|
12 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Sameena Iqbal, MD, McGill University Health Centre/Research Institute of the McGill University Health Centre
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- 14-275-GEN
Piano per i dati dei singoli partecipanti (IPD)
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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