Skip to content

A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus

A Care Model for Hip-fractured Elderly Persons With Diabetes Mellitus

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01051830
Enrollment
176
Registered
2010-01-20
Start date
2010-01-31
Completion date
2014-12-31
Last updated
2017-02-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Hip Fracture

Brief summary

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.

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.

Interventions

OTHERDiabetes interdisciplinary program

Diabetes consulting, rehabilitation program

Sponsors

National Health Research Institutes, Taiwan
CollaboratorOTHER
Chang Gung Memorial Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. 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), 2. Diagnosed with DM, 3. Admitted to CGMH from its emergency room due to hip fracture, and 4. Living in northern Taiwan (i.e.,greater Taipei area, Keelung, Taoyuan, or Shin-Ju Province).

Exclusion criteria

1. Clinical diagnosis of Cancer 2. Can't communicate with researchers

Design outcomes

Primary

MeasureTime frame
Quality of life2 years

Secondary

MeasureTime frame
Activities of Daily life2 years

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026