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The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO) and work productivity data of the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) +/- Ribavirin (RBV) in chronic hepatitis C virus (HCV) infected participants in Austria.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chronic infection of HCV GT1 or GT4 | Participants with confirmed chronic hepatitis C genotype (GT) 1 or 4, receiving combination therapy with the interferon-free ABBVIE REGIMEN (ombitasvir/paritaprevir/ritonavir +/- dasabuvir) ± Ribavirin (RBV) according to standard of care and in line with the current local label |
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug. | 12 Weeks after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants With Virological Response at End of Treatment (EoTR) | The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]). | Up to 24 weeks of treatment |
| Percentage of Participants With On-treatment Virologic Failure (Breakthrough) |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Planned Duration of Ribavirin (RBV) Taken | Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]). | Up to 24 weeks of treatment |
| Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire |
Inclusion Criteria:
Treatment-naïve or -experienced adult male or female patients with confirmed chronic hepatitis C, genotype (GT)1 or GT4, receiving combination therapy with the interferon-free ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label
If RBV is co-administered with the ABBVIE REGIMEN, it has been prescribed in line with the current local label (with special attention to contraception requirements and contraindication during pregnancy)
Patients must voluntarily sign and date a patient authorization to use and disclose his/her anonymized health data prior to inclusion into the study
Patient must not be participating or intending to participate in a concurrent interventional therapeutic trial
Exclusion Criteria:
none
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Patients with chronic infection of HCV Genotype 1 (GT1) or Genotype 4 (GT4)
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| Name | Affiliation | Role |
|---|---|---|
| Alexander P Dorr, PhD | AbbVie Austria | Study Director |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30739368 | Derived | Ferenci P, Bourgeois S, Buggisch P, Norris S, Curescu M, Larrey D, Marra F, Kleine H, Dorr P, Charafeddine M, Crown E, Bondin M, Back D, Flisiak R. Real-world safety and effectiveness of ombitasvir/paritaprevir/ritonavir +/- dasabuvir +/- ribavirin in hepatitis C virus genotype 1- and 4-infected patients with diverse comorbidities and comedications: A pooled analysis of post-marketing observational studies from 13 countries. J Viral Hepat. 2019 Jun;26(6):685-696. doi: 10.1111/jvh.13080. Epub 2019 Mar 5. |
| Label | URL |
|---|---|
| Related Info | View source |
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A total of 173 patients were enrolled in the study; 2 patients never started treatment and were excluded from the safety (SP; N=171); 6 patients were excluded from the core population (CP; N=165), defined as all SP patients who met eligibility criteria and were adequately treated according to the standard of care and local label recommendations.
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| ID | Title | Description |
|---|---|---|
| FG000 | ABBVIE REGIMEN +/- Ribavirin (RBV) | ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | ABBVIE REGIMEN +/- Ribavirin (RBV) | ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir |
| Units | Counts |
|---|---|
| Participants |
|
| 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 | Percentage of Participants Achieving Sustained Virological Response 12 Weeks Post-treatment (SVR12) | SVR12 is defined as hepatitis C virus ribonucleic acid (HCV RNA) levels < 50 IU/mL 12 weeks after the last actual dose of study drug. | The Core Population (CP) was defined as all patients in the safety population (SP; all enrolled subjects who received at least 1 dose of study drug) who met eligibility criteria and were adequately treated according to the standard of care and within local label recommendations. | Posted | Number | 95% Confidence Interval | percentage of participants | 12 Weeks after the last dose of study drug |
|
Treatment-emergent adverse events (TEAEs) and serious adverse events (TESAEs) were collected from the first dose of study drug until 30 days post-study drug dosing (up to 28 weeks).
TEAEs and TESAEs are defined as any adverse event (AE) with an onset date that is after the first dose of study drug until 30 days after the last dose of study drug.
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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 | ABBVIE REGIMEN +/- Ribavirin (RBV) | ABBVIE REGIMEN ± Ribavirin (RBV) according to standard of care and in line with the current local label where ABBVIE REGIMEN included ombitasvir/paritaprevir/ritonavir +/- dasabuvir |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global Medical Services | AbbVie | 800-633-9110 | abbvieclinicaltrials@abbvie.com |
| ID | Term |
|---|---|
| D019698 | Hepatitis C, Chronic |
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
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The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]). |
| Up to approximately 24 weeks |
| Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up) | SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU). | 12 weeks after last dose of study drug |
| Percentage of Participants With Post-treatment Relapse | The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL) | Up to 12 weeks after last dose of study drug |
The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management. |
| Day 0 and End of Treatment (EoT) |
| Percentage of Participants With Concomitant Medications | Percentage of participants taking at least 1 concomitant medication | Day 0 to end of treatment (up to 24 weeks) |
| Percentage of Participants With Co-morbidities and/or Co-infections | Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0). | Day 0 |
| Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement. | Day 0 and post treatment week 12 |
| Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire | The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem | Day 0 to post treatment week 12 |
| Patient Support Program (PSP) Utilization and Satisfaction Assessment | The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP. | Up to 24 weeks of treatment |
| Percentage of Participants With Adherence to Planned RBV Target Dose Taken | Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%. | Up to 24 weeks of treatment |
| Percentage of Participants Deviating From the Target ABBVIE Regimen Duration | Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days. | Up to 24 weeks of treatment |
| Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken | Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%. | Up to 24 weeks of treatment |
| Death |
|
| Not further specified |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
|
|
| Secondary | Percentage of Participants With Virological Response at End of Treatment (EoTR) | The percentage of participants with virological response (HCV RNA <50 IU/mL) at end of treatment (EoT, defined as last intake of ABBVIE REGIMEN or ribavirin [RBV]). | Core Population (CP) | Posted | Number | 95% Confidence Interval | percentage of participants | Up to 24 weeks of treatment |
|
|
|
| Secondary | Percentage of Participants With On-treatment Virologic Failure (Breakthrough) | The percentage of participants with on-treatment virologic failure (breakthrough [defined as at least one documented HCV RNA <50 IU/mL followed by HCV RNA >= 50 IU/mL during treatment]). | Core Population (CP) | Posted | Number | percentage of participants | Up to approximately 24 weeks |
|
|
|
| Secondary | Percentage of Participants Achieving SVR12 (Core Population Sufficient Follow-up) | SVR12 is defined as HCV RNA levels < 50 IU/mL 12 weeks after the last actual dose of study drug in the Core Population Sufficient Follow-up (CPSFU). | CP subjects with evaluable HCV RNA data ≥70 days after last dose AbbVie Regimen, or HCV RNA value ≥50IU/mL at last measurement postbaseline, or HCV RNA <50IU /mL at last measurement postbaseline, but no HCV RNA value ≥70 days after last dose AbbVie Regimen due to safety or virologic failure (relapse reported but date/value of HCV RNA test missing). | Posted | Number | 95% Confidence Interval | percentage of participants | 12 weeks after last dose of study drug |
|
|
|
| Secondary | Percentage of Participants With Post-treatment Relapse | The percentage of participants with relapse (defined as HCV RNA <50 IU/mL at EoT followed by HCV RNA ≥50 IU/mL) | Core Population (CP) | Posted | Number | percentage of participants | Up to 12 weeks after last dose of study drug |
|
|
|
| Other Pre-specified | Percentage of Planned Duration of Ribavirin (RBV) Taken | Adherence to RBV is defined as percentage of target dose (adherence=cumulated dose taken/ [initially prescribed dose x planned duration]). | All participants in the Core Population (CP) who received RBV | Posted | Mean | Standard Deviation | percentage of planned RBV dose taken | Up to 24 weeks of treatment |
|
|
|
| Other Pre-specified | Total Score of Participant Activation According to the Patient Activation Measure (PAM-13) Questionnaire | The PAM-13 item scale is a measure used to assess the patient knowledge, skill, and confidence for self-management. Each of the 13 items can be answered with one of four possible response options, which are "disagree strongly" (1), "disagree" (2), "agree" (3), "agree strongly" (4). Responses are summed and averaged to come up with an overall score of level 1 through level 4. The responses to the 13 questions are summed and transformed into a PAM Score between 0 and 100; a higher score indicates more knowledge and confidence to take action for self-management. | Core Population (CP) | Posted | Mean | Standard Deviation | score on a scale | Day 0 and End of Treatment (EoT) |
|
|
|
| Other Pre-specified | Percentage of Participants With Concomitant Medications | Percentage of participants taking at least 1 concomitant medication | The safety population (SP) was defined as enrolled patients who received at least 1 dose of ABBVIE REGIMEN. | Posted | Number | percentage of participants | Day 0 to end of treatment (up to 24 weeks) |
|
|
|
| Other Pre-specified | Percentage of Participants With Co-morbidities and/or Co-infections | Percentage of participants with co-morbidities and/or co-infections at baseline (Day 0). | Core Population (CP) | Posted | Number | percentage of participants | Day 0 |
|
|
|
| Other Pre-specified | Quality of Life Measured With the EuroQol 5 Dimension 5 Level (EQ-5D-5L) Questionnaire | The EQ-5D-5L is a health state utility instrument that evaluates preference for health status (utility). The 5 items in the EQ-5D-5L comprise 5 dimensions (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) to describe the subject's current health state. Each dimension comprises 5 levels with corresponding numeric scores, where 1 indicates no problems, and 5 indicates extreme problems. A unique EQ-5D-5L health state is defined by combining the numeric level scores for each of the 5 dimensions and the total score is normalized from -0.594 to 1.000, with higher scores representing a better health state. An increase in the EQ-5D-5L total score indicates improvement. The EQ-5D visual analogue scale (VAS) records the participant's self-rated health status on a vertical graduated scale from 0 to 100, with 0 indicating the worst imaginable health state and 100 indicating the best imaginable health state. An increase in EQ-5D-5L VAS score indicates improvement. | Core Population (CP) | Posted | Mean | Standard Deviation | score on a scale | Day 0 and post treatment week 12 |
|
|
|
| Other Pre-specified | Change in Mean Score From Baseline to 12 Weeks After End of Treatment (EOT) in Work Productivity and Activity Impairment (WPAI) Version 2: Hepatitis C Questionnaire | The WPAI questionnaire was used to measure work absenteeism, work presenteeism, work productivity impairment and daily activity impairment. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity: Presenteeism - percentage of impairment while working due to health problem; Total work productivity impairment - percentage of overall work impairment due to health problem Absenteeism - percentage of work time missed due to health problem; Total activity impairment - percentage of general (non-work) activity impairment due to health problem | Core Population (CP) | Posted | Mean | Standard Deviation | percentage | Day 0 to post treatment week 12 |
|
|
|
| Other Pre-specified | Patient Support Program (PSP) Utilization and Satisfaction Assessment | The AbbVie PSP included educational and information material (including printed, online, pillbox), digital and mobile resource (web-portal), digital and mobile resources (reminders). The PSP utilization and satisfaction assessment evaluated the frequency of utilization (usually daily, several times per week, usually once weekly, less than once weekly) and patient's overall satisfaction (very good, good, satisfactory) with their respective PSP. | Core Population (CP) | Posted | Number | percentage of participants | Up to 24 weeks of treatment |
|
|
|
| Other Pre-specified | Percentage of Participants With Adherence to Planned RBV Target Dose Taken | Adherence to RBV is defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% - <=105%, >80% - <=95%, >50% - <=80%, <=50%. | All participants in the Core Population (CP) who received RBV | Posted | Number | percentage of participants | Up to 24 weeks of treatment |
|
|
|
| Other Pre-specified | Percentage of Participants Deviating From the Target ABBVIE Regimen Duration | Deviations from the target dose of the ABBVIE REGIMEN were defined as the actual duration is shortened/prolonged (exceedence) for more than 7 days. | Core Population (CP) | Posted | Number | percentage of participants | Up to 24 weeks of treatment |
|
|
|
| Other Pre-specified | Percentage of Participants With Adherence to Planned ABBVIE Regimen Target Dose Taken | Adherence to the ABBVIE REGIMEN was defined as percentage of target dose (adherence=cumulated number of pills taken / [initially prescribed number of pills x planned duration]) and categorized as follows: >105%, >95% to <=105%, >80% to <=95%, >50% to <=80%, <=50%. | Core Population (CP) | Posted | Number | percentage of participants | Up to 24 weeks of treatment |
|
|
|
| 5 |
| 171 |
| 27 |
| 171 |
| Vomiting | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Cardiac Failure | Cardiac disorders | MedDRA 19.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 19.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 19.1 | Systematic Assessment |
|
| Drug Hypersensitivity | Immune system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 19.1 | Systematic Assessment |
|
| Hepatocellular Carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 19.1 | Systematic Assessment |
|
| Chronic Kidney Disease | Renal and urinary disorders | MedDRA 19.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 19.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 19.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 19.1 | Systematic Assessment |
|
AbbVie requests that any investigator or institution that plans on presenting/publishing results disclosure, provide written notification of their request 60 days prior to their presentation/publication. AbbVie requests that no presentation/publication will be instituted until 12 months after a study is completed, or after the first presentation/publication whichever occurs first. A delay may be proposed of a presentation/publication if AbbVie needs to secure patent or proprietary protection.
| D006525 |
| Hepatitis, Viral, Human |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
| D012327 | RNA Virus Infections |
| D006521 | Hepatitis, Chronic |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Title | Measurements |
|---|---|
|
| Beta blocking agents |
|
| Calcium channel blockers |
|
| Thyroid therapy |
|
| Vitamins |
|
| Blood glucose lowering drugs |
|
| Drugs used in addictive disorders |
|
| ACE inhibitors |
|
| Angriotensin II antagonists |
|
| Anti-asthmatics |
|
| Benzodiazepine derivatives |
|
| Antithrombotic |
|
| Drugs for peptic ulcer/gastroesophageal reflux dis |
|
| Angiotensin II Antagonists |
|
| Antipsychotics |
|
| Diuretics |
|
| ACE inhibitors, combinations |
|
| Insulin and analogues |
|
| Mineral supplements |
|
| Antieplieptics |
|
| Anti-inflammatory and antirheumatic products |
|
| Drugs used in benign prostatic hypertrophy |
|
| Herbal medicine |
|
| Vasodilators for cardiac diseases |
|
| Anti-dementia drugs |
|
| Antibacterials |
|
| Anti-gout preparations |
|
| Drugs for functional gastrointestinal disorders |
|
| HMG COA reductase inhibitors |
|
| Hypnotics and sedatives |
|
| Immunosuppressive agents |
|
| Lipotropics |
|
| Vasoprotectives |
|
| Anti-adrenergic antihypertensives |
|
| Antibiotics for dermatological use |
|
| Antiemetics and anti nauseants |
|
| Antigloucoma |
|
| Antihistamines |
|
| Antineoplastic/immunomodulating agents, cytostatic |
|
| Title | Measurements |
|---|---|
|
| Chronic kidney disease |
|
| Psychiatric disorders |
|
| Diabetes mellitus |
|
| Lipid disorder |
|
| Hyperthyroidism |
|
| Hypothyroidism |
|
| Cardiovascular disease |
|
| Immunologically medicated disease |
|
| Psychoactive substance dependency |
|
| Other |
|
|
| EQ-5D-5L: VAS Score Basline |
|
|
| EQ-5D-5L: VAS Score 12 Weeks EOT |
|
|
|
| Change from baseline in total work impairment |
|
|
| Change from baseline in total activity impairment |
|
|
| Title | Measurements |
|---|---|
|
| Personal support satisfaction - Satisfactory |
|
| Title | Measurements |
|---|---|
|
| >50% - <=80% Adherence |
|
| <=50% Adherence |
|
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|
| >50% - <=80% Adherence |
|
| <=50% Adherence |
|