MultimorbidityNCT05985044
Living With Multimorbidity: CO-ORDINATE Program
A study testing Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention in people with Multimorbidity and Quality of Life, run by Johns Hopkins University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Multimorbidity, Quality of Life, Symptom Management
- What is being tested?
- Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Nov 2022to 30 May 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Who can not provide informed consent or have documented cognitive impairment
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Nursing
Baltimore, Maryland, 21205
About this study
Official title: Living With Multimorbidity: Symptom Management Across the Illness Trajectory
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.
Read the 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
- Symptom Burden
- Quality of Life
- Conditions
- Multimorbidity, Quality of Life, Symptom Management
- Being tested
- Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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).
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention Receives: Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline, 6-weeks post intervention, 3 months post intervention
Secondary outcomes (4)
Health-care Utilization - Total Healthcare Utilization
Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.
Measured: 3 months before and after entering the program
Health-care Utilization - Emergency Department (ED) Visit s
Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.
Measured: 3 months before and after entering the program
Health-care Utilization - Hospitalization
Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions.. Higher the numbers higher the healthcare utilization.
Measured: 3 months before and after entering the program
Health-care Utilization - Critical Care Admission
Health-care utilization data will be retrieved from electronic medical records. The study team is defining healthcare utilization by identifying no. of total healthcare utilization, hospitalizations, emergency visits, and critical care admissions. Higher the numbers higher the healthcare utilization.
Measured: 3 months before and after entering the program
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start16 Nov 2022
- Primary completion2 Mar 2024
- Study completion30 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MultimorbidityStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Responsible party
- Sponsor
- Investigators
- Binu Koirala, PhD, Principal investigator, Johns Hopkins School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05985044
- Sponsor's protocol ID
- IRB00244792
- Other IDs
- P30NR018093
- Status last verified
- Jan 2025
- First submitted
- 2 Aug 2023
- Last updated
- 28 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38110376
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living With Multimorbidity: Symptom Management Across the Illness Trajectory
- ClinicalTrials.gov ID
- NCT05985044
- Acronym / sponsor ID
- IRB00244792
- Conditions
- Multimorbidity, Quality of Life, Symptom Management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute of Nursing Research (NINR)
- Study start
- 16 Nov 2022 (actual)
- Primary completion
- 2 Mar 2024 (actual)
- Study completion
- 30 May 2024 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Posted 28 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Symptom Burden
- Quality of Life
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) InterventionA patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- Who can not provide informed consent or have documented cognitive impairment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) InterventionThe 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). | Other | Intervention |
Primary outcome
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 - 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 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 - 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.
4 secondary outcomes
Health-care Utilization - Total Healthcare Utilization
Time frame: 3 months before and after entering the program
Health-care Utilization - Emergency Department (ED) Visit s
Time frame: 3 months before and after entering the program
Health-care Utilization - Hospitalization
Time frame: 3 months before and after entering the program
Health-care Utilization - Critical Care Admission
Time frame: 3 months before and after entering the program
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38110376Koirala 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Binu Koirala, PhD principal investigator
Johns Hopkins School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention in people with Multimorbidity and Quality of Life, run by Johns Hopkins University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 28 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptom Burden Assessed by Edmonton Symptom Assessment System (ESAS) Score - Pain (time frame: Baseline, 6-weeks post intervention, 3 months post intervention). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05985044, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.