A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01051830|
Recruitment Status : Completed
First Posted : January 20, 2010
Last Update Posted : February 8, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus Hip Fracture||Other: Diabetes interdisciplinary program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||176 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus|
|Study Start Date :||January 2010|
|Actual Primary Completion Date :||December 2014|
|Actual Study Completion Date :||December 2014|
Experimental: Interdisciplinary group
Diabetes intervention and rehabilitation program. The rehabilitation program includes geriatric consultation, the rehabilitation program (interventions to improve ROM, muscle strength and endurance, proprioceptive enhancement, balance capacity, aerobic and anaerobic capacity, flexibility, and body composition), and discharge-planning services. The DM intervention includes: dietary and DM education, blood pressure control, dyslipidemia management, a glycemic treatment regimen, and exercises.
Other: Diabetes interdisciplinary program
Diabetes consulting, rehabilitation program
No Intervention: Control group
- Quality of life [ Time Frame: 2 years ]
- Activities of Daily life [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01051830
|Chang Gung Memorial Hospital, Taiwan|
|Taipei, Taoyuan, Taiwan|
|Principal Investigator:||Yea-Ing L Shyu, PhD||Chang Gung University|