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临床试验/NCT05985044
NCT05985044已完成不适用

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Johns Hopkins University2 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年11月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
27
试验地点
2
主要终点
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain

研究概览

简要总结

Multimorbidity is common and is the coexistence of two or more chronic conditions in the same individual. People with multimorbidity suffer from a high symptom burden, directly affecting quality of life (QOL). Hospitalization can be a window of opportunity to initiate interventions to promote recovery and resilience and enhance QOL. However, interventions targeting the symptom trajectory and burden of patients with multimorbidity are lacking. Thus, the investigators envisage a nurse-led pre-discharge intervention augmented by telephone support, focusing on care coordination and symptom management. This approach is anticipated to help reduce symptom burden and improve QOL.

详细描述

Aim 1: Describe the symptom trajectory and burden from the perspectives of patients, family caregivers, and health professionals and collectively develop a symptom management toolkit; and

Aim 2: Refine and pilot test the nurse-driven symptom management toolkit/intervention to decrease the symptom burden and increase the QOL of critically ill adults with multimorbidity.

Interventional study (Aim 2):

The study aims to test the feasibility of the Care cOORDInatioN and sympTom managEment (COORDINATE) intervention developed from Aim 1 using an experienced-based co-design methodology. A single-arm feasibility study will be implemented with assumptions on the effectiveness of the COORDINATE intervention on outcomes such as symptom burden and quality of life will be evaluated.

Sample and Setting:

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

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

入选标准

  • English speakers who are planned for discharge from Johns Hopkins Hospital (JHH) IMCU
  • Who meet the criteria for being admitted to IMCU and planned discharge with multimorbidity as defined by two or more chronic conditions.

排除标准

  • Who can not provide informed consent or have documented cognitive impairment

结局指标

主要结局

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Tiredness

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Drowsiness

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Nausea

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Lack of Appetite

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Shortness of Breath

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Depression

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Anxiety

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Well-being

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

The ESAS questionnaire is used to rate the intensity of common symptoms including pain, tiredness, nausea, depression, anxiety, drowsiness, appetite, well-being, and shortness of breath; with ratings ranging from 0 (none, best) to 10 (worst).

Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Physical

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Physical Functioning

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Emotional

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Vitality

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Mental Health

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Social Functioning

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - Bodily Pain

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

Quality of Life Assessed by Short Form Survey (SF-36) Score - General Health

时间窗: Baseline, 6-weeks post intervention, 3 months post intervention

Short Form Survey (SF-36) is a 36-item self-reported quality of life that covers 8 domains; score range 0 to 100. Higher score is better quality of life.

次要结局

  • Health-care Utilization - Total Healthcare Utilization(3 months before and after entering the program)
  • Health-care Utilization - Emergency Department (ED) Visit s(3 months before and after entering the program)
  • Health-care Utilization - Hospitalization(3 months before and after entering the program)
  • Health-care Utilization - Critical Care Admission(3 months before and after entering the program)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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