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Clinical Trials/NCT05985044
NCT05985044
Completed
Not Applicable

Living With Multimorbidity: Symptom Management Across the Illness Trajectory

Johns Hopkins University1 site in 1 country27 target enrollmentNovember 16, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Multimorbidity
Sponsor
Johns Hopkins University
Enrollment
27
Locations
1
Primary Endpoint
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain
Status
Completed
Last Updated
last year

Overview

Brief Summary

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.

Detailed Description

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: Individuals aged 55 years and older, living with two or more chronic health conditions, and willing to provide informed consent will be included in the study. The exclusion criteria include if participants cannot speak English or have a documented cognitive impairment that would prevent participation. Patients will be approached in the Intermediate Care Unit (IMCU) of an academic teaching hospital while the participants are in-patient before discharge. Intervention Components and Timing: The intervention consists of four components- i) needs assessment; ii) question prompt list; iii) goals discussion and; iv) symptom assessment and tracking. The intervention will start with the enrolment of a patient living with multimorbidity. The intervention consists of one in-person pre-discharge visit by the study team and four follow-up telephone calls (at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge). Primary Outcomes 1. Symptom Burden 2. Quality of Life

Registry
clinicaltrials.gov
Start Date
November 16, 2022
End Date
May 30, 2024
Last Updated
last year
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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