Diabetes Mellitus Clinical Trial
Official title:
A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
The purpose of this study is to 1) develop a well-conceived and feasible protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM, and 2) compare the costs and effectiveness of this DM-specific model with those of an effective subacute care model previously developed by our research team.
Clinical and scientific significance. Health outcomes, as well as physical and cognitive
function, have been shown to be negatively impacted by comorbidity beyond the bare sum of
effects due to the single diseases. One such comorbidity is diabetes mellitus (DM), a global
health issue and the fifth major cause of death in Taiwan from 1987 to 2001. Starting in
2002, DM has become the fourth. Hip-fractured elderly persons with DM were shown in our
previous studies to have significantly higher mortality and readmission rates and poorer
recovery in walking ability and various physical health outcomes than those without DM
during the first year after discharge. Clinical evidence has shown that elderly patients
with hip fracture can benefit from postoperative rehabilitation, early discharge-planning
programs, or transitional care programs. However, little is known about effective
interventions specifically for hip fractured patients with DM.
Research Purposes. The purpose of this study is to 1) develop a well-conceived and feasible
protocol for hospital discharge and subacute care for hip-fractured elderly persons with DM,
and 2) compare the costs and effectiveness of this DM-specific model with those of an
effective subacute care model previously developed by our research team.
Data and Methods. A clinical trial with 1-year follow-up will be used to compare the
cost-effectiveness of the DM-specific model in 88 hip-fractured elderly patients with that
of our subacute care model (n=88) and routine care (n=88). Patients will be recruited
through the emergency room of Chang Gung Memorial Hospital (CGMH) at Lin Kuo. Subjects will
be assessed before surgery, before discharge, at 1, 3, 6, and 12 months after discharge for
biometric measures, DM-related outcomes, clinical outcomes, self-care ability,
health-related quality of life, service utilization, and costs of care. To maximize outcomes
sensitive to the intervention, biometric measures of activity will be included, i.e., daily
energy consumption and arterial stiffness index. DM-related variables will include
haemoglobin A1c (HbA1c), tendon reflexes, superficial and deep sensation, peripheral pulses,
diabetic retinopathy, signs of "diabetic foot," use of medication, and clinical procedures.
The study has already been approved by the Institutional Review Board of CGMH. Trajectories
of the outcome variables and their predictors will be analyzed by the generalized estimating
equations (GEE) approach. The cost of the three care models will also be compared. Findings
of this study can contribute to current knowledge and practice for elderly patients with DM
recovering from hip-fracture surgery.
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