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Chronic Kidney Disease Among Frail Elderly (FRED-CKD)

2021年5月24日 更新者: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.

調査の概要

状態

完了

詳細な説明

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.

研究の種類

介入

入学 (実際)

14

段階

  • 適用できない

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

    • Quebec
      • Montreal、Quebec、カナダ
        • McGill University Health Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

65年歳以上 (高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

説明

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).

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか?

デザインの詳細

  • 主な目的:処理
  • 割り当て:非ランダム化
  • 介入モデル:単一グループの割り当て
  • マスキング:なし(オープンラベル)

武器と介入

参加者グループ / アーム
介入・治療
実験的: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
他の名前:
  • 理学療法
  • nutritional therapy
  • supportive therapy
介入なし:Non adherence
Those who were offered the program but did not complete the prescription

この研究は何を測定していますか?

主要な結果の測定

結果測定
メジャーの説明
時間枠
Mortality
時間枠: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

二次結果の測定

結果測定
メジャーの説明
時間枠
Number of Patients Progressed to the Need for Renal Replacement Therapy (Any Modality or Palliation).
時間枠:6 months
Number of patients progressed to the need for renal replacement therapy (any modality or palliation).
6 months
Hospitalizations
時間枠: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
時間枠:12 weeks
assessed by applying the data of the 4 meter walk compared between the two study groups.
12 weeks
Time up and go
時間枠:12 weeks
one of the physical functioning parameters
12 weeks
Dominant Hand Grip
時間枠:12 weeks
right hand grip average of three values
12 weeks

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

捜査官

  • 主任研究者:Sameena Iqbal, MD、McGill University Health Centre/Research Institute of the McGill University Health Centre

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始

2016年1月1日

一次修了 (実際)

2016年12月15日

研究の完了 (実際)

2016年12月15日

試験登録日

最初に提出

2015年1月27日

QC基準を満たした最初の提出物

2015年1月29日

最初の投稿 (見積もり)

2015年1月30日

学習記録の更新

投稿された最後の更新 (実際)

2021年5月26日

QC基準を満たした最後の更新が送信されました

2021年5月24日

最終確認日

2021年5月1日

詳しくは

本研究に関する用語

その他の研究ID番号

  • 14-275-GEN

個々の参加者データ (IPD) の計画

個々の参加者データ (IPD) を共有する予定はありますか?

いいえ

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