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NCT05985044

Living With Multimorbidity: CO-ORDINATE Program

Completed NA Results posted Last updated 28 January 2025
What this trial tests

NA trial testing Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention in Multimorbidity in 27 participants. Completed in 30 May 2024.

Timeline
16 November 2022
Primary endpoint
2 March 2024
30 May 2024

Quick facts

Lead sponsorJohns Hopkins University
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposesupportive care
Enrollment27
Start date16 November 2022
Primary completion2 March 2024
Estimated completion30 May 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

55 and older, any sex, with Multimorbidity or Quality of Life. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Baseline
GroupValue95% CI
Intervention50 – 8
6-week
GroupValue95% CI
Intervention41 – 6
3-month
GroupValue95% CI
Intervention52 – 7
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Tiredness Primary · 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).

Baseline
GroupValue95% CI
Intervention32 – 5
6-week
GroupValue95% CI
Intervention33 – 4
3-month
GroupValue95% CI
Intervention63 – 7
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Drowsiness Primary · 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).

Baseline
GroupValue95% CI
Intervention20 – 5
6-week
GroupValue95% CI
Intervention30 – 4
3-month
GroupValue95% CI
Intervention52 – 6
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Nausea Primary · 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).

Baseline
GroupValue95% CI
Intervention00 – 0
6-week
GroupValue95% CI
Intervention00 – 0.3
3-month
GroupValue95% CI
Intervention10 – 2.5
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Lack of Appetite Primary · 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).

Baseline
GroupValue95% CI
Intervention00 – 0
6-week
GroupValue95% CI
Intervention10 – 6
3-month
GroupValue95% CI
Intervention3.31 – 4
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Shortness of Breath Primary · 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).

Baseline
GroupValue95% CI
Intervention00 – 4
6-week
GroupValue95% CI
Intervention31 – 4
3-month
GroupValue95% CI
Intervention53 – 5
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Depression Primary · 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).

Baseline
GroupValue95% CI
Intervention00 – 3
6-week
GroupValue95% CI
Intervention31 – 5
3-month
GroupValue95% CI
Intervention4.51 – 6
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Anxiety Primary · 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).

Baseline
GroupValue95% CI
Intervention00 – 5
6-week
GroupValue95% CI
Intervention20.5 – 6
3-month
GroupValue95% CI
Intervention2.50 – 5
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Well-being Primary · 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).

Baseline
GroupValue95% CI
Intervention50 – 7
6-week
GroupValue95% CI
Intervention43.3 – 6.5
3-month
GroupValue95% CI
Intervention3.32 – 5
Quality of Life Assessed by Short Form Survey (SF-36) Score - Physical Functioning Primary · 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.

Baseline
GroupValue95% CI
Intervention5012.5 – 62.5
6-week
GroupValue95% CI
Intervention4025 – 60
3-month
GroupValue95% CI
Intervention32.510 – 65
Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Physical Primary · 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.

Baseline
GroupValue95% CI
Intervention250 – 25
6-week
GroupValue95% CI
Intervention00 – 100
3-month
GroupValue95% CI
Intervention00 – 75
Quality of Life Assessed by Short Form Survey (SF-36) Score - Role Emotional Primary · 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.

Baseline
GroupValue95% CI
Intervention33.330 – 100
6-week
GroupValue95% CI
Intervention33.330 – 100
3-month
GroupValue95% CI
Intervention16.670 – 100

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Study protocol for Care cOORDInatioN And sympTom managEment (COORDINATE) programme: a feasibility study.
    Koirala B, Badawi S, Frost S, Ferguson C, et al · · 2023 · cited 1× · PMID 38110376 · DOI 10.1136/bmjopen-2023-072846

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Other recruiting trials for Multimorbidity

Currently open trials in the same condition.

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Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05985044.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing