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| ID | Type | Description | Link |
|---|---|---|---|
| P30NR018093 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Nursing Research (NINR) | NIH |
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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention | Experimental | A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 3 months before and after entering the program |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Binu Koirala, PhD | Johns Hopkins School of Nursing | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Nursing | Baltimore | Maryland | 21205 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38110376 | Derived | 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. |
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Out of the 27 participants who signed the informed consent, 25 completed the baseline survey and received the intervention. Two participants did not complete the baseline data collection and could not be reached after signing the consent form.
The participant was approached and recruited in the Intermediate Care Unit (IMCU) of an academic teaching hospital while the participants are in-patient before discharge. The recruitment of eligible participant took approximately 9 months from November 16, 2022 to August 2, 2023.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention | The participants received the Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention, which includes the following four components: i) needs assessment, ii) question prompt list, iii) goals discussion, and iv) symptom assessment and tracking. The intervention comprises one in-person pre-discharge visit by the study team and four follow-up telephone calls conducted at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | The participants received the Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention, which includes the following four components: i) needs assessment, ii) question prompt list, iii) goals discussion, and iv) symptom assessment and tracking. The intervention comprises one in-person pre-discharge visit by the study team and four follow-up telephone calls conducted at 48 hours, 1 week, 4 weeks, and 6 weeks post-discharge. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
|
Up to 18 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | A patient-centered Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) intervention Care cO-ORDInatioN And sympTom managEment (CO-ORDINATE) Intervention: 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). |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr.Binu Koirala | Johns Hopkins University School of Nursing | 707-225-2166 | bkoiral1@jhu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 22, 2022 | Nov 12, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 22, 2022 | Nov 12, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D010166 | Palliative Care |
| D008722 | Methods |
| ID | Term |
|---|---|
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
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|
| 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 |
| 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. | 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. | 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. | 3 months before and after entering the program |
| Withdrawal by Subject |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Symptom burden - Pain | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Tiredness | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Drowsiness | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Nausea | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Lack of appetite | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Shortness of breath | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Depression | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Anxiety | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Symptom burden - Well-being | The Symptom burden assessed by Edmonton Symptom Assessment System (ESAS) score; with ratings ranging from 0 (none, best) to 10 (worst). Mean of participant choice is reported. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Physical functioning | Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Role Physical | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life -Role Emotional | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Vitality | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Mental Health | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Social Functioning | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - Social Functioning | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
| Quality of Life - General health | The Quality of Life assessed by Short Form Survey (SF-36) score; score range 0 to 100. Higher score is better quality of life. | Mean | Standard Deviation | units on a scale |
|
|
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
|
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
|
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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). | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who competed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who completed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who completed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Primary | 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. | Participants who completed the survey at each time point are reported. | Posted | Median | Inter-Quartile Range | score on a scale | Baseline, 6-weeks post intervention, 3 months post intervention |
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| Secondary | 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. | One outlier was excluded from the data. | Posted | Median | Inter-Quartile Range | Care utilization events | 3 months before and after entering the program |
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| Secondary | 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. | Participants who had data available are reported. | Posted | Median | Inter-Quartile Range | Care utilization events | 3 months before and after entering the program |
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| Secondary | 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. | Participants who had data available are reported. | Posted | Median | Inter-Quartile Range | Care utilization events | 3 months before and after entering the program |
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| Secondary | 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. | Participants who had data available are reported. | Posted | Median | Inter-Quartile Range | Care utilization events | 3 months before and after entering the program |
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| 6 |
| 25 |
| 0 |
| 25 |
| 0 |
| 25 |
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| D008919 | Investigative Techniques |
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