Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00155597
Status:
COMPLETED
Last Update Posted:
2010-01-12
First Post:
2005-09-09
Brief Title:
The Outcome and Cost Analysis of Home-care Physical Therapy for Postoperative Hip Fracture Patients
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2009-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aims of this study are
1 To develop a disease-specific questionnaire for hip fractures
2 To find the influences of physical therapy PT on patients function and health-related quality of life HRQL
3 To estimate the quality adjusted life years QALY of cases of hip fracture with or without the PT program by a quality-adjusted survival QAS method
4 To perform cost effectiveness analysis CEA to evaluate the effectiveness of PT and as a base to compare it with other health intervention programs
At the beginning of the study the investigators will develop the disease-specific questionnaire for hip fractures Cases of patients with hip fractures hospitalized in orthopedic wards of the National Taiwan University Hospital NTUH and Chung-Hsing Hospital of Taipei from August 1 1989 to July 31 1999 are the study population during the first year of this study According to their receiving PT or not during hospitalization the patients are assigned to a PT or non-PT group The identification ID numbers will be matched with the death certificate file of the Department of Health to verify the survival status Furthermore 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fractures Combining the survival function and HRQL the QALY could be estimated Cases of hip fracture admitted to the orthopedic ward of NTUH and receiving a PT program from January 1 2000 will be the second-year study population in this study They will be randomly assigned to a group of follow-up PT group I or non-follow-up PT group II The patients assigned to group I will have a 4-time PT evaluation and treatment at home after discharge from the hospital 1 week 1 month 3 months and 6 months after discharge All patients will be evaluated at discharge 1 month 6 months and 1 year after discharge to follow their survival status functional status and HRQL The expected results of this study will be to develop the disease-specific questionnaire for hip fractures to show the functional outcomes of cases of hip fracture and to estimate the QALY of them
1 To develop a disease-specific questionnaire for hip fractures
2 To find the influences of physical therapy PT on patients function and health-related quality of life HRQL
3 To estimate the quality adjusted life years QALY of cases of hip fracture with or without the PT program by a quality-adjusted survival QAS method
4 To perform cost effectiveness analysis CEA to evaluate the effectiveness of PT and as a base to compare it with other health intervention programs
At the beginning of the study the investigators will develop the disease-specific questionnaire for hip fractures Cases of patients with hip fractures hospitalized in orthopedic wards of the National Taiwan University Hospital NTUH and Chung-Hsing Hospital of Taipei from August 1 1989 to July 31 1999 are the study population during the first year of this study According to their receiving PT or not during hospitalization the patients are assigned to a PT or non-PT group The identification ID numbers will be matched with the death certificate file of the Department of Health to verify the survival status Furthermore 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fractures Combining the survival function and HRQL the QALY could be estimated Cases of hip fracture admitted to the orthopedic ward of NTUH and receiving a PT program from January 1 2000 will be the second-year study population in this study They will be randomly assigned to a group of follow-up PT group I or non-follow-up PT group II The patients assigned to group I will have a 4-time PT evaluation and treatment at home after discharge from the hospital 1 week 1 month 3 months and 6 months after discharge All patients will be evaluated at discharge 1 month 6 months and 1 year after discharge to follow their survival status functional status and HRQL The expected results of this study will be to develop the disease-specific questionnaire for hip fractures to show the functional outcomes of cases of hip fracture and to estimate the QALY of them
Detailed Description:
Hip fracture from fall is the most important cause of disability of the aged Most of the victims receive surgery internal fixation or arthroplasty as the primary treatment However during the hospitalization of post-surgery not all the patients receive physical therapy PT The program of PT during hospitalization and after discharge affects the functional recovery and the health-related quality of life HRQL significantly in our knowledge Therefore the aims of this study are
1 To develop the disease-specific questionnaire for hip fracture
2 To find the influences of PT on patients function and HRQL
3 To estimate the QALY of cases of hip fracture with or without PT program by quality-adjusted survival QAS method
4 To perform CEA to evaluate the effectiveness of PT and as a base to compare with other health intervention program
At the beginning of the study we will develop the disease-specific questionnaire for hip fracture And cases of hip fracture hospitalized in orthopedic wards of National Taiwan University Hospital NTUH and Chung-Hsing Hospital of Taipei from August 1 1989 to July 31 1999 are the study population of the first year in this study According to their receiving PT or not during hospitalization the patients are assigned to PT or non-PT group Basic data such as ID number age sex comorbidity pre-injury physical status operation date operation type length of hospitalization complication are extracted from their charts The identification ID numbers will be matched with the death certificate file of the Department of Health to make sure the survival status Furthermore 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fracture Combining the survival function and HRQL the QALY could be estimated Cases of hip fracture admit to the orthopedic ward of NTUH and receive PT program from Jan 1 2000 will be the second-year study population in this study They will be randomly assigned to group of follow-up PT group I or non-follow-up PT group II The patients assigned to group I will have 4-time PT evaluation and treatment at home after discharge from hospital 1 week 1-month 3-month and 6-month after discharge All patients will be evaluated at discharge 1-month 6-month and 1-year after discharge to follow their survival status functional status and HRQL The patients younger than 65 years old will be further evaluated for their working capacity at the last evaluation In the third year of this study medical cost and estimated QALY will be collected to perform the CEA for the effectiveness of PT program during hospitalization and after discharge
The expected results of this study will be to develop the disease-specific questionnaire for hip fracture to show the functional outcome of cases with hip fracture to estimate the QALY of them and to perform a CEA to demonstrate the effectiveness of PT
1 To develop the disease-specific questionnaire for hip fracture
2 To find the influences of PT on patients function and HRQL
3 To estimate the QALY of cases of hip fracture with or without PT program by quality-adjusted survival QAS method
4 To perform CEA to evaluate the effectiveness of PT and as a base to compare with other health intervention program
At the beginning of the study we will develop the disease-specific questionnaire for hip fracture And cases of hip fracture hospitalized in orthopedic wards of National Taiwan University Hospital NTUH and Chung-Hsing Hospital of Taipei from August 1 1989 to July 31 1999 are the study population of the first year in this study According to their receiving PT or not during hospitalization the patients are assigned to PT or non-PT group Basic data such as ID number age sex comorbidity pre-injury physical status operation date operation type length of hospitalization complication are extracted from their charts The identification ID numbers will be matched with the death certificate file of the Department of Health to make sure the survival status Furthermore 30 cases per group per year will be randomly sampled to interview their HRQL and evaluate their function with the disease-specific questionnaire for hip fracture Combining the survival function and HRQL the QALY could be estimated Cases of hip fracture admit to the orthopedic ward of NTUH and receive PT program from Jan 1 2000 will be the second-year study population in this study They will be randomly assigned to group of follow-up PT group I or non-follow-up PT group II The patients assigned to group I will have 4-time PT evaluation and treatment at home after discharge from hospital 1 week 1-month 3-month and 6-month after discharge All patients will be evaluated at discharge 1-month 6-month and 1-year after discharge to follow their survival status functional status and HRQL The patients younger than 65 years old will be further evaluated for their working capacity at the last evaluation In the third year of this study medical cost and estimated QALY will be collected to perform the CEA for the effectiveness of PT program during hospitalization and after discharge
The expected results of this study will be to develop the disease-specific questionnaire for hip fracture to show the functional outcome of cases with hip fracture to estimate the QALY of them and to perform a CEA to demonstrate the effectiveness of PT
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None