Health Condition 1: D578- Other sickle-cell disorders
Conditions
Interventions
Intervention1: Not Applicable: Not Applicable
Control Intervention1: Not Applicable: Not Applicable
Sponsors
Novartis Healthcare Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults and paediatric patients >=2 years of age visiting health care setup. 2. Male and female patients with confirmed diagnosis (Laboratory Diagnosis) of SCD with any genotype. 3. Diagnosed with SCD at least 12 months prior to the index visit 4. Patients (or legally authorized representatives in case of paediatric patients) who provide informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients who are not willing to provide informed consent 2. Pediatric patients who do not have a legally authorized representative (LAR) to provide the consent 3. Patients receiving crizanlizumab or any other investigational product for managing Vaso-occlusive during and previous 12 months from the day of study enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.The proportion of the SCD patients reporting at least one VOC among all the SCD patients visiting the study centres during the study period. 2.The total number of VOCs resulting in health care visit among all the health care visits of SCD patients during the study period.Timepoint: 1.All the study visits during the study period. 2.All health care visits during the study period. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.The proportion of patients with complicated VOCs and presenting with severe VOC in patients visiting the health care centre.Timepoint: 1.All the study visits during the study period.;2. The proportion of patients treated with oral opiates, parenteral opioid medications, oral NSAIDs, parenteral NSAIDs, supportive treatments, chronic transfusion program, currently on complementary/ alternative therapies.Timepoint: 2. For 7 years age: The severity of the current episode of VOC will be assessed using validated Pain Severity Assessment Scale.;3. The frequency of VOC in the past one year leading to - any health care visit, an emergency department visit, outpatient visit, inpatient admission, community physician visit, total number of days of inpatient admissions.Timepoint: 3.At Baseline visit;4. The frequency of VOC occurrence at home and The reasons for managing the crisis at home in the past one year.Timepoint: 4. At Baseline visit;5. a. The frequency of VOC occurrence in the past one year (both at home and hospitals) b. The proportion of patients having â?? 0 VOCs, 1-2 VOCs, 3-5 VOCs, 5-10 VOCs and 10VOCs.Timepoint: 5.a. At Baseline visit b. All the study visits during the study period.;6. The proportion of patients currently on HU therapy, treated with HU in the past who are currently not on HU and The reason for discontinuation of HU.Timepoint: 6. At Baseline visit and all the study visits during the study period;7.a.The proportion of SCD patients with chronic complications and/or EOD (including lab parameters as per routine practice) among all the SCD population. b.The age-wise distribution of chronic complications and EOD (including any laboratory parameters as per routine practice)Timepoint: 7.At Baseline visit and all the study visits during the study period;8. QOL of SCD patients using validated QOL and the impact of VOC on QOL.Timepoint: 8. At baseline;9. The cost incurred among patients and the healthcare system for management of VOC a. Direct cost | — |
Countries
India
Contacts
Public ContactDr Manish Mistry
Novartis Healthcare Private Limited
Outcome results
None listed