- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02883348
Satisfaction With Care and Quality of Life (SATISQOL)
Satisfaction With Care and Quality of Life After Hospital Stay for Chronic Disease
Study Overview
Status
Conditions
Detailed Description
Background: Evaluating the impact of complex procedures of patient care for chronic disease patients is one of the objectives and priorities defined in the French framework of the Public Health Act of August 2004. The relevant indicators that predict the impact of the medium-term hospitalization on the quality of life remain to be explored.
Preliminary data showed that care satisfaction, usual indicator of quality of care, was associated with quality of life away from the hospital, especially in the field of orthopedics (prosthetic surgery). Satisfaction is an indicator currently collected in routine periodic surveys in all establishments. This project will test the hypothesis of the prognostic role of this satisfaction after a medical or a surgical treatment in people hospitalized for chronic disease.
Objective: The objective of this research is to investigate the prognostic value of satisfaction with care on the quality of life of patients with chronic disease hospital, at 6 months and 1 year of discharge.
Patients and methods: A multicenter cohort of 1520 patients hospitalized in medical and surgical units for chronic disease (in the field of cardiovascular, musculoskeletal, nephrology, urology, digestive, pulmonary or endocrine). Patients will respond to PJHQ satisfaction questionnaire at the waning of their hospital stay. The quality of life (SF-36) will be measured at 6 months and 1 year after hospitalization.
The socio-demographic characteristics, diagnosis, anxiety state (HAD), optimistic / pessimistic personality (LOT-R), comorbidities (Charlson and Functional comorbidity index), major health events (rehospitalization, death ) and the characteristics of the stays and care structure (cluster services) who welcomed them will be saved.
The number of subjects required was calculated based on a cluster sampling (13 poles or services between institutions) to highlight with a power of 80% a difference of 5 points of quality of life among the satisfied and less satisfied subjects.
Statistical analysis will study the relationship of satisfaction scores with QoL dimensions at 6 months and 1 year, in hierarchical regression multilevel models adjusted for confounding variables.
Study Type
Enrollment (Actual)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Age: 40-75 years
- Patients hospitalized for treatment of chronic disease, defined as a disease lasting for more than 6 months, and confirmed by a validation committee
Hospitalization motivation is:
- A care of an acute episode of a chronic disease
- A car of a worsening of chronic disease
- A new therapeutic of a chronic disease
Exclusion Criteria:
- Patients who did not have a therapeutic intervention during their hospitalization (i.e., diagnostic analysis or medical follow-up without change of their treatment)
- Patients with more than 5 hospitalizations during the previous 5 years (more than 1 per year)
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Change in quality of life score
Time Frame: 6 months and 1 year
|
6 months and 1 year
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Satisqol
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
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