A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus Hip Fracture |
Other: Diabetes interdisciplinary program Other: Rehabilitation program, nursing care |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus |
- Quality of life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
- Activities of Daily life [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 264 |
| Study Start Date: | January 2010 |
| Estimated Study Completion Date: | December 2014 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Interdisciplinary group
Diabetes intervention and rehabilitation program
|
Other: Diabetes interdisciplinary program
Diabetes consulting, rehabilitation program
Other Name: Diabetes interdisciplinary program
|
| No Intervention: Control group | |
|
Sham Comparator: Subacute group
Only apply rehabilitation program
|
Other: Rehabilitation program, nursing care
Rehabilitation program, nursing care
Other Name: Rehabilitation program, nursing care
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 60 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Age 60 years or older (this criterion is based on our previous NHRI-funded study: Intervention program for elderly patients with hip fracture, 2001-2003),
- Diagnosed with DM,
- Admitted to CGMH from its emergency room due to hip fracture, and
- Living in northern Taiwan (i.e.,greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).
Exclusion Criteria:
- Clinical diagnosis of Cancer
- Can't communicate with researchers
Contacts and Locations| Contact: Yueh-Fang Huang, Master | +886-3-2118999 ext 3203 | yfhuang@mail.cgit.edu.tw |
| Taiwan | |
| Chang Gung Memorial Hospital, Taiwan | Recruiting |
| Taipei, Taoyuan, Taiwan | |
| Contact: Yueh-Fang Huang, Master +886-3-2118999 ext 3203 yfhuang@mail.cgit.edu.tw | |
| Principal Investigator: | Yea-Ing L Shyu, PhD | Chang Gung University |
More Information
No publications provided
| Responsible Party: | Yea-Ing Lotus Shyu, Professor, Chang Gung University |
| ClinicalTrials.gov Identifier: | NCT01051830 History of Changes |
| Other Study ID Numbers: | 98-0327B-P04I99N, CGMH-98-0327B |
| Study First Received: | January 17, 2010 |
| Last Updated: | February 10, 2012 |
| Health Authority: | Taiwan: Institutional Review Board |
Additional relevant MeSH terms:
|
Diabetes Mellitus Hip Fractures Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Femoral Fractures Fractures, Bone Wounds and Injuries Hip Injuries Leg Injuries |
ClinicalTrials.gov processed this record on May 22, 2013