Cirrhosis, Liver
Conditions
Brief summary
To address the health care system's lack of care coordination, the Institute of Medicine and Centers for Medicare and Medicaid Services recommend the development of collaborative care models (CCM) in a wide range of clinical settings. CCMs are intended to provide coordinated, personalized care pragmatically using care coordinators. CCMs have successfully improved care in multiple patient populations, ranging from frail older adults to depression. In contrast, for patients with cirrhosis, there is a paucity of data to support the benefit of CCM in this medically complex and vulnerable population. At Indiana University, researchers have over 20 years of experience in developing, testing, and implementing CCMs successfully for patients living with dementia or depression. Building on these successes, we have customized the CCM to best meet the unique and complex biopsychosocial needs of patients with cirrhosis: the Cirrhosis Medical Home.
Detailed description
In the Cirrhosis Medical Home, a care coordinator, supported by an interdisciplinary clinical team, will deliver a personalized intervention guided by a set of innovative tools: (i) patient-centered care protocols, (ii) a mobile office, (iii) care coordination support software, and (iv) dynamic feedback measures. The overall goal is to improve quality of life of patients discharged from the hospital with cirrhosis and to reduce acute health care utilization for patients with cirrhosis. Additionally, up to 40 caregivers will be enrolled in the trial.
Interventions
OTHERCare Coordinator Intervention for Direct Intervention Group
The First Visit: The care coordinator will conduct a visit within 72 hours of hospital discharge to assess the patient's physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These measures will be used to guide the use of care protocols and development of the individualized care plan. The care plan will be developed with an emphasis on coordinating services with the patient's providers. The Second Visit: During the second visit, the coordinator will review the individualized care plan with both the patient and the family caregiver and will make revisions to the plan based on assessment outcomes. The 6-month Interaction Period: Approximately every 2 weeks, the coordinator will meet with the participant to revisit the care plan and to facilitate care. At the end of 6 months, all patients will be transitioned to receive full care by their primary care and specialty physicians.
OTHERCare Coordinator Intervention for Standard of Care Group
For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm.
Caregivers of the participants will be assessed for caregiver burden at 3 time points.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Indiana University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
TRIPLE (Subject, Caregiver, Investigator)
Masking description
One member of the study team will randomize the participants and all other study personnel will remain blinded.
Intervention model description
Block randomization will be utilized to ensure balancing of treatment groups throughout enrollment. 20 participants will be assigned to the direct home interventions group and 20 will be assigned to standard of care. Caregivers (40) belong to a single arm of the study with no randomization. All receive the same study procedures.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
for patients: * Age ≥18 years * Cirrhosis based on: * biopsy * characteristic clinical, laboratory, and imaging findings * Decompensated cirrhosis as denoted by either: * active ascites requiring paracentesis during hospitalization or * active overt hepatic encephalopathy requiring lactulose during hospitalization * Poor quality of life as defined by: * SF-36 Physical and/or Mental Component Summary scale \<40 (1SD below the mean of healthy subjects) * Discharged to home, skilled nursing facility, sub-acute rehabilitation care, or long-term acute care * Able to be consented, either in person or through legally authorized representative * Access to a telephone Inclusion criteria for caregivers: * Age ≥18 years * Identified caregiver of patient * Able to be consented, either in person or through legally authorized representative * Access to a telephone
Exclusion criteria
for patients: * Solid organ transplant of any organ * Life expectancy of less than 6 months * Anticipated liver transplant within 6 months * History of dementing illnesses and other neurodegenerative diseases such as Alzheimer's disease, Parkinson's disease, or vascular dementia * Unable to complete study questionnaire due to hearing loss * Legally blind * Pregnant or nursing * Incarcerated * Concurrent enrollment in a related interventional research study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment Rate | Time of Enrollment | The proportion of screened patients eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics. |
| Number of Participants Who Dropped Out or Are Lost to Follow-up | At drop out date or lost to follow-up date, which every comes first an average of 6 months | This is the proportion of enrolled participants (patients) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics. |
| Number of Participants With Complete Data | Through study completion, an average of 6 months | Completeness of the data collection for enrolled subjects and reasons for incomplete data will be recorded. This is an internal assessment relating not to participants but to department specific metrics. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Physical Performance | measure was completed at initial enrollment by patients only | Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument. |
| Anxiety Symptoms | measure was completed at initial enrollment by patients only | Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score. |
| Acute Health Care Utilization | 6 months | This is an assessment of patient use of health care resources, including hospitalizations and Emergency room visits. For the patient only, data will be gathered from the patient and medical record relating to the participant's emergency room visits and hospital admissions/inpatient stays during the course of their enrollment in the study. |
| Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | measure was completed at initial enrollment by patients only | Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is \> -4 (better). \<= -5 is abnormal (worse). |
| Caregiver Burden | caregivers completed at initial enrollment--while the plan was to complete at 3 and 6 months, none of the participants with liver disease for whom these people cared were alive at the 3 and 6 month mark so the instruments were not completed | Assessment from caregivers only through data collection from the Zarit Burden Interview-12 (ZBI-12) instrument; a lower score is generally indicative of a lower amount caregiver fatigue or perception of burden; a higher score generally correlates to a greater level of caregiver fatigue/perceived burden. 0-10 no burden, 10-20 mild-moderate burden, \>20 high burden. Minimum: 0 Maximum: 48 |
| Cognitive Assessment With 3D CAM (Confusion Assessment Method) | measure was completed at initial enrollment by patients only | Assessment of overall levels of cognitive status, including hepatic encephalopathy |
| Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | measure was completed at enrollment by patients only | Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers. |
| Depression Symptoms | measure was completed at initial enrollment by patients only | Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score. |
Countries
United States
Participant flow
Pre-assignment details
The protocol allowed for up to 40 caregivers to enroll in this trial. We enrolled 4 caregivers. The protocol called for 40 participants with liver disease to be enrolled and we enrolled 40. Total enrollment is 44.
Participants by arm
| Arm | Count |
|---|---|
| Direct Intervention Initial Evaluation: Prior to discharge, the care coordinator will review the hospital discharge plan, obtain the approval of the patient's physicians to co-manage the patient's care, and schedule a visit at the place of discharge.
Participants receive direct interaction with a care coordinator to develop an individualized care plan. Frequent assessments will occur to continue to follow or to modify the care plan based on the needs of the patient.
At the end of 6 months, all patients will be transitioned to full care by their primary care and specialty physicians and their participation in this study will be ended.
Care Coordinator Intervention for Direct Intervention Group: The coordinator will conduct a visit within 72 hours of discharge to assess the physical, cognitive, and psychological status, and will complete a needs assessment for both the patient and family caregiver. These will be used to guide the care protocols and development of the individualized care plan. The care plan is developed with an emphasis on coordinating services with the patient's providers.
During the second visit, the individualized care plan is reviewed with the patient and family caregiver and revisions are made based on assessment outcomes.
The 6-month Interaction Period: The coordinator and participant meet to revisit the care plan and to facilitate care. At the end of 6 months, all patients are transitioned to full care by their primary care and specialty physicians. | 20 |
| Standard of Care Prior to hospital discharge, the care coordinator will identify the primary care and/or hepatology provider of patients in the usual care group and will ensure follow up appointments at the time of hospital discharge. The coordinator will compose and send a letter to the primary care and/or hepatology provider summarizing the patient's diagnosis, hospital course, discharge medications, and the plan of follow-up care. If the patient does not already have a primary care or hepatology provider, the coordinator will work with the patient to identify a new provider. Subjects in this group will receive no further intervention.
Care Coordinator Intervention for Standard of Care Group: For participants randomized to this arm, a consultation with the care team will be arranged prior to hospital discharge. Outcome measures will be obtained by blinded research staff from all enrolled subjects at baseline, 3 months, and 6 months. This is the extent of interventions received for participants in this arm. | 20 |
| Caregiver The caregivers of people with cirrhosis will be enrolled in the study. They will complete the assessments at baseline, 3 months and 6 months.
Caregiver Intervention: Caregivers of the participants will be assessed for caregiver burden at 3 time points. | 4 |
| Total | 44 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 7 | 6 | 0 |
| Overall Study | liver transplant | 2 | 2 | 0 |
| Overall Study | Lost to Follow-up | 7 | 3 | 0 |
| Overall Study | transitioned to hospice care | 0 | 5 | 0 |
Baseline characteristics
| Characteristic | Direct Intervention | Standard of Care | Caregiver | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 1 Participants | 12 Participants |
| Age, Categorical Between 18 and 65 years | 14 Participants | 15 Participants | 3 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 20 Participants | 20 Participants | 4 Participants | 44 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 19 Participants | 19 Participants | 4 Participants | 42 Participants |
| Region of Enrollment United States | 20 participants | 20 participants | 4 participants | 44 participants |
| Sex: Female, Male Female | 12 Participants | 15 Participants | 2 Participants | 29 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 2 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 7 / 20 | 6 / 20 | 0 / 4 |
| other Total, other adverse events | 0 / 20 | 0 / 20 | 0 / 4 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 4 |
Outcome results
Primary
Enrollment Rate
The proportion of screened patients eligible, approached and enrolled will be calculated. This is an internal assessment relating not to participants but to department specific metrics.
Time frame: Time of Enrollment
Population: Participants were screened prior to being approached for enrollment. Only after informed consent was obtained were participants randomized to a group. The numbers reported are in the aggregate for those with liver disease only and not for a particular group. Data for caregivers were not tracked.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Intervention | Enrollment Rate | 20 Participants |
| Standard of Care | Enrollment Rate | 20 Participants |
Primary
Number of Participants Who Dropped Out or Are Lost to Follow-up
This is the proportion of enrolled participants (patients) who drop out of the study before completion. This is an internal assessment relating not to participants but to department specific metrics.
Time frame: At drop out date or lost to follow-up date, which every comes first an average of 6 months
Population: Data for caregivers was not tracked. Of note we had no participants withdraw but a number were lost to follow-up.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Intervention | Number of Participants Who Dropped Out or Are Lost to Follow-up | 3 Participants |
| Standard of Care | Number of Participants Who Dropped Out or Are Lost to Follow-up | 7 Participants |
Primary
Number of Participants With Complete Data
Completeness of the data collection for enrolled subjects and reasons for incomplete data will be recorded. This is an internal assessment relating not to participants but to department specific metrics.
Time frame: Through study completion, an average of 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Intervention | Number of Participants With Complete Data | 4 Participants |
| Standard of Care | Number of Participants With Complete Data | 4 Participants |
| Caregiver | Number of Participants With Complete Data | 4 Participants |
Secondary
Acute Health Care Utilization
This is an assessment of patient use of health care resources, including hospitalizations and Emergency room visits. For the patient only, data will be gathered from the patient and medical record relating to the participant's emergency room visits and hospital admissions/inpatient stays during the course of their enrollment in the study.
Time frame: 6 months
Population: Information not measured for caregivers in this outcome.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Direct Intervention | Acute Health Care Utilization | 17 Participants |
| Standard of Care | Acute Health Care Utilization | 18 Participants |
| Caregiver | Acute Health Care Utilization | 0 Participants |
Secondary
Anxiety Symptoms
Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.
Time frame: measure was completed at initial enrollment by patients only
Population: scores at initial enrollment by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Anxiety Symptoms | 7 units on a scale | Standard Deviation 0.11 |
| Standard of Care | Anxiety Symptoms | 9 units on a scale | Standard Deviation 0.11 |
Secondary
Anxiety Symptoms
Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.
Time frame: measure was completed at 6 months by patients only
Population: scores at 6 months by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Anxiety Symptoms | 16 units on a scale | Standard Deviation 0.2 |
| Standard of Care | Anxiety Symptoms | 16 units on a scale | Standard Deviation 0.2 |
Secondary
Anxiety Symptoms
Assessment from patient only through data collection from the Generalized Anxiety Disorder Scale (GAD-7) instrument. This 7 item instrument that assess anxiety has a minimum score of 0 and a maximum score of 21, with a lower score indicating no or lesser anxiety than a higher score.
Time frame: measure was completed at 3 months by patients only
Population: scores at 3 months by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Anxiety Symptoms | 14 units on a scale | Standard Deviation 0.11 |
| Standard of Care | Anxiety Symptoms | 14 units on a scale | Standard Deviation 0.15 |
Secondary
Caregiver Burden
Assessment from caregivers only through data collection from the Zarit Burden Interview-12 (ZBI-12) instrument; a lower score is generally indicative of a lower amount caregiver fatigue or perception of burden; a higher score generally correlates to a greater level of caregiver fatigue/perceived burden. 0-10 no burden, 10-20 mild-moderate burden, \>20 high burden. Minimum: 0 Maximum: 48
Time frame: caregivers completed at initial enrollment--while the plan was to complete at 3 and 6 months, none of the participants with liver disease for whom these people cared were alive at the 3 and 6 month mark so the instruments were not completed
Population: Caregivers of patients with liver disease who enrolled in the Cirrhosis Medical Home study were eligible for study enrollment.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Caregiver Burden | 10 units on a scale | Standard Deviation 0.5 |
Secondary
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Time frame: measure was completed at 3 months by patients only
Population: measurement was not administered so no outcome data are available
Secondary
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Time frame: measure was completed at initial enrollment by patients only
Population: measurement was not administered so no outcome data are available
Secondary
Cognitive Assessment With 3D CAM (Confusion Assessment Method)
Assessment of overall levels of cognitive status, including hepatic encephalopathy
Time frame: measure was completed at 6 months by patients only
Population: measurement was not administered so no outcome data are available
Secondary
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is \> -4 (better). \<= -5 is abnormal (worse).
Time frame: measure was completed at 6 month enrollment by patients only
Population: scores at 6 month enrollment by patients only; caregivers were not included in this measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 2 Participants |
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 0 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 1 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 1 Participants |
Secondary
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is \> -4 (better). \<= -5 is abnormal (worse).
Time frame: measure was completed at 3 month enrollment by patients only
Population: scores at 3 month enrollment by patients only; caregivers were not included in this measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 3 Participants |
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 0 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 3 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 1 Participants |
Secondary
Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score)
Assessment of overall levels of cognitive status, including hepatic encephalopathy. PHES range is -18 to +6. Normal is \> -4 (better). \<= -5 is abnormal (worse).
Time frame: measure was completed at initial enrollment by patients only
Population: scores at initial enrollment by patients only; caregivers were not included in this measure
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 11 Participants |
| Direct Intervention | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 7 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score >-5 | 3 Participants |
| Standard of Care | Cognitive Assessment With PHES (The Psychometric Hepatic Encephalopathy Score) | score ≤-5 | 14 Participants |
Secondary
Depression Symptoms
Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.
Time frame: measure was completed at 3 months by patients only
Population: scores at 3 months by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Depression Symptoms | 14 score on a scale | Standard Deviation 0.15 |
| Standard of Care | Depression Symptoms | 14 score on a scale | Standard Deviation 0.11 |
Secondary
Depression Symptoms
Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.
Time frame: measure was completed at 6 months by patients only
Population: scores at 6 months by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Depression Symptoms | 12 score on a scale | Standard Deviation 0.2 |
| Standard of Care | Depression Symptoms | 18 score on a scale | Standard Deviation 0.18 |
Secondary
Depression Symptoms
Assessment from patient only through data collection from the Patient Health Questionnaire-9 (PHQ-9) instrument. This 9 item instrument that assesses depression and has a minimum score of 0 and a maximum score of 27; a lower score generally indicates no or a lesser amount of depression/anxiety than a higher score.
Time frame: measure was completed at initial enrollment by patients only
Population: scores at initial enrollment by patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Depression Symptoms | 11 score on a scale | Standard Deviation 0.044 |
| Standard of Care | Depression Symptoms | 14 score on a scale | Standard Deviation 0.11 |
Secondary
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.
Time frame: measure was completed at 3 months by patients only
Population: scores at 3 month enrollment for patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 84 score on a scale | Standard Error 0.8 |
| Standard of Care | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 88 score on a scale | Standard Error 0.4 |
Secondary
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.
Time frame: measure was completed at 6 months by patients only
Population: scores at 6 month enrollment for patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 102 score on a scale | Standard Error 0.5 |
| Standard of Care | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 100 score on a scale | Standard Error 0.7 |
Secondary
Health Related Quality of Life: Medical Outcome Study Short Form (SF-36)
Assessment from the patient only through data collection from the Medical Outcome Study Short Form (SF-36) instrument. This 36 item questionnaire has a minimum score of 36 with a maximum score of 180; a higher score generally correlates to poorer health. This assessment was for patients only and not for caregivers.
Time frame: measure was completed at enrollment by patients only
Population: scores at initial enrollment for patients only; caregivers were not included in this measure
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Direct Intervention | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 56 score on a scale | Standard Error 0.7 |
| Standard of Care | Health Related Quality of Life: Medical Outcome Study Short Form (SF-36) | 58 score on a scale | Standard Error 0.7 |
Secondary
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Time frame: measure was completed at 6 months by patients only
Population: measurement was not administered so no outcome data are available
Secondary
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Time frame: measure was completed at 3 months by patients only
Population: measurement was not administered so no outcome data are available
Secondary
Physical Performance
Assessment from the patient only through data collection from the Short Physical Performance Battery (SPPB) instrument.
Time frame: measure was completed at initial enrollment by patients only
Population: measurement was not administered so no outcome data are available