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临床试验/NCT02504021
NCT02504021已完成不适用

Family Consultation for High-Risk Inpatients With End Stage Renal Disease: A Randomized Trial

Mark A. Lumley2 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年7月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
120
试验地点
2
主要终点
Early Hospital Readmissions - 1 Month

研究概览

简要总结

A randomized clinical trial for patients with end stage renal disease in which a family consultation condition is compared against a treatment as usual control condition on the hospital readmissions after 1 month as the primary outcome variable.

详细描述

Patients hospitalized at Henry For Hospital who have end stage renal disease will complete baseline questionnaires and be randomized into the experimental or control condition. Patients randomized into the experimental condition will have a single family consultation session before the patient is discharged. A trained, master's level therapist will conduct the family consultation, which will use education, motivational interviewing, and other techniques to help the family engage and support the patient's health needs. Patients in both the experimental and control conditions will complete follow up questionnaires 1 month after discharge. Investigators will conduct chart reviews of outcome data, including readmissions, at 1, 3, and 6 months post-discharge.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Hospitalized in inpatient Nephrology Unit at Henry Ford Hospital
  • Has end-stage renal disease
  • Willing and able to contact support person / family member about participating in the study

排除标准

  • Persistent Delirium
  • Non-English speaking

研究组 & 干预措施

Family Consultation Condition

Experimental

The family consultation will be one, 1-hour session conducted by trained, master's level therapists. The goals of the meetings are: a) Review patient and family understanding of events that caused the hospital admission; b) increase family awareness of the level of cognitive impairment that the patient is experiencing; c) discuss ways the family can get involved and help the patient with their medication and dialysis adherence; d) use motivational interviewing techniques as needed. This will be provided in addition to the usual care that inpatients receive in this unit.

干预措施: Family Consultation (Behavioral)

Treatment as Usual Control Condition

No Intervention

Standard of care for the nephrology unit.

结局指标

主要结局

Early Hospital Readmissions - 1 Month

时间窗: 1 Month

Were patients readmitted to the hospital within 1 month of their initial discharge?

次要结局

  • Change in Depression(Baseline and 1-month follow-up)
  • Change in Medication Adherence(Baseline and 1-month follow-up)
  • Change in Biological Measures of Health(Baseline, 1, and 3 months)
  • Change in Instrumental Social Support(Baseline and 1-month follow-up)
  • Hospital Readmissions - 3 Months(3 Months)
  • Change in Anxiety(Baseline and 1-month follow-up)

研究者

发起方
Mark A. Lumley
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Mark A. Lumley

Professor

Wayne State University

研究点 (2)

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