NCT05985044

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
27

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 16, 2022

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

August 2, 2023

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 2, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 30, 2024

Completed
8 months until next milestone

Results Posted

Study results publicly available

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

1.3 years

First QC Date

August 2, 2023

Results QC Date

November 14, 2024

Last Update Submit

January 2, 2025

Conditions

MultimorbidityQuality of LifeSymptom Management

Outcome Measures

Primary Outcomes (17)

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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).

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

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

    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.

    Baseline, 6-weeks post intervention, 3 months post intervention

Secondary Outcomes (4)

  • 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 Arms (1)

Intervention

EXPERIMENTAL

A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention

Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention

Interventions

Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) InterventionOTHER

The intervention consists of the following 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).

Intervention

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins School of Nursing

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

  • Koirala B, Badawi S, Frost S, Ferguson C, Hager DN, Street L, Perrin N, Dennison Himmelfarb C, Davidson P. Study protocol for Care cOORDInatioN And sympTom managEment (COORDINATE) programme: a feasibility study. BMJ Open. 2023 Dec 18;13(12):e072846. doi: 10.1136/bmjopen-2023-072846.

    PMID: 38110376DERIVED

MeSH Terms

Interventions

Palliative CareMethods

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesInvestigative Techniques

Limitations and Caveats

Because of the feasibility design, the study is not powered. Hence, changes in primary and secondary outcomes over time (i.e., baseline vs 6 weeks and 3 months) must be considered carefully.

Results Point of Contact

Title
Dr.Binu Koirala
Organization
Johns Hopkins University School of Nursing
bkoiral1@jhu.edu
707-225-2166

Study Officials

  • Binu Koirala, PhD

    Johns Hopkins School of Nursing

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2023

First Posted

August 14, 2023

Study Start

November 16, 2022

Primary Completion

March 2, 2024

Study Completion

May 30, 2024

Last Updated

January 28, 2025

Results First Posted

January 28, 2025

Record last verified: 2025-01

Locations

US(1)